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Launching Your Own Contract Research Organization: A Step-By-Step Guide

In today’s rapidly evolving pharmaceutical and healthcare industries, Contract Research Organizations (CROs) play a crucial role in supporting the development of new drugs and medical treatments. As an aspiring entrepreneur, launching your own CRO can be a rewarding and lucrative venture. This step-by-step guide will provide you with the necessary insights and strategies to successfully establish and grow your CRO business.

Table of Contents

Definition of a Contract Research Organization (CRO)

A Contract Research Organization, commonly known as a CRO, is a specialized company that provides research and development services to pharmaceutical, biotechnology, and medical device companies. CROs offer a wide range of services, including clinical trials management, regulatory compliance, data management, and statistical analysis. These organizations act as strategic partners, assisting their clients in navigating the complex process of bringing new drugs and medical treatments to market.

Importance of launching your own CRO

Launching your own CRO can be a highly rewarding endeavor for several reasons. Firstly, the demand for CRO services is steadily increasing as the pharmaceutical industry continues to grow. With the rising costs and complexities associated with drug development, pharmaceutical companies are increasingly outsourcing their research and development activities to CROs. This presents a significant opportunity for aspiring entrepreneurs to enter the market and establish a successful CRO business.

Secondly, the CRO industry offers attractive profit margins. As a CRO, you can charge premium fees for your specialized services, making it a financially lucrative business. Additionally, the recurring nature of contracts and long-term client relationships can provide a stable revenue stream for your CRO.

Lastly, launching your own CRO allows you to make a meaningful impact on the healthcare industry. By supporting the development of new drugs and medical treatments, you contribute to improving patient outcomes and advancing medical science. This sense of purpose and fulfillment can be a driving force behind your entrepreneurial journey.

Overview of the step-by-step guide

This step-by-step guide will provide you with a comprehensive roadmap to launch and grow your CRO business. Each step will cover essential aspects of establishing a successful CRO, including market analysis, defining your business model, setting up your CRO, building a team, developing strategic partnerships, marketing and branding, ensuring regulatory compliance, managing finances, securing clients and projects, and scaling your CRO.

By following this guide, you will gain valuable insights into the CRO industry, learn how to define your niche and target clients, understand the legal and regulatory considerations, build a competent team, develop strategic partnerships, implement effective marketing strategies, ensure regulatory compliance, manage your finances, secure clients and projects, and ultimately scale and grow your CRO.

In conclusion, launching your own CRO can be a highly rewarding and profitable venture. This step-by-step guide will equip you with the knowledge and strategies needed to navigate the complexities of the CRO industry and establish a successful business. So, let’s dive into the first step: understanding the CRO industry through market analysis and research.

Step 1: Understanding the CRO Industry

The Contract Research Organization (CRO) industry plays a crucial role in the development of new drugs and medical treatments. CROs provide a wide range of services to pharmaceutical companies, biotechnology firms, and research institutions, helping them conduct clinical trials, collect data, and navigate regulatory requirements. If you are considering launching your own CRO, it is essential to have a deep understanding of the industry. In this step, we will explore the key aspects of the CRO industry and how to position your business for success.

Market Analysis and Research

Before diving into the CRO industry, it is crucial to conduct thorough market analysis and research. This will help you identify the current market trends, potential clients, and the demand for CRO services. Start by examining the size of the market and its growth rate. Look for reports and studies that provide insights into the industry’s future prospects.

Additionally, research the specific therapeutic areas or niches within the CRO industry. Understanding which areas are in high demand can help you tailor your services and target the right clients. For example, oncology, neurology, and rare diseases are often areas where CROs are in high demand.

Identifying Target Clients and Services

Once you have a clear understanding of the CRO industry, it is essential to identify your target clients and the services you will offer. Consider the types of organizations you want to work with, such as pharmaceutical companies, biotech startups, or academic research institutions. Understanding your target clients will help you tailor your marketing efforts and develop a compelling value proposition.

Next, determine the specific services you will provide as a CRO. This can include clinical trial management, data collection and analysis, regulatory compliance, and project management. Assess the demand for these services in your target market and ensure that you have the necessary expertise and resources to deliver high-quality results.

Assessing Competition and Market Trends

Competition in the CRO industry can be fierce, so it is crucial to assess your competitors and stay updated on market trends. Research other CROs operating in your target market and analyze their strengths, weaknesses, and service offerings. This will help you identify gaps in the market that you can capitalize on and differentiate your business from the competition.

Additionally, staying informed about market trends is essential for long-term success. Keep an eye on emerging technologies, regulatory changes, and shifts in client preferences. This will allow you to adapt your services and stay ahead of the curve.

By thoroughly understanding the CRO industry, identifying target clients and services, and assessing competition and market trends, you will be well-equipped to launch your own CRO. This knowledge will help you make informed decisions, develop a compelling value proposition, and position your business for success in this dynamic and rapidly evolving industry.

Stay tuned for the next step in our guide, where we will explore how to define your business model and choose a niche or specialization within the CRO industry.

Step 2: Defining Your Business Model

In the process of launching your own Contract Research Organization (CRO), it is crucial to define a solid business model that will guide your operations and ensure long-term success. This step involves making important decisions regarding your niche or specialization, the scope of services you will offer, and your pricing strategy. Let’s delve deeper into each aspect:

Choosing a niche or specialization

To stand out in the competitive CRO industry, it is essential to choose a niche or specialization that aligns with your expertise and market demand. By focusing on a specific area, you can establish yourself as an expert and attract clients who require specialized services.

Consider conducting market research to identify gaps or emerging trends in the industry. This will help you determine which niche has the potential for growth and profitability. For example, you might specialize in oncology research, medical device trials, or clinical data management.

Determining the scope of services

Once you have chosen your niche, it is important to define the scope of services you will offer. This includes identifying the specific research and development activities you will undertake for your clients.

Your scope of services may include clinical trial management, regulatory affairs, data management, statistical analysis, or medical writing. It is crucial to align your services with the needs of your target clients and ensure that you have the necessary expertise and resources to deliver high-quality results.

Developing a pricing strategy

Pricing your services appropriately is a critical aspect of your business model. It is important to strike a balance between being competitive in the market and ensuring profitability.

Consider factors such as the complexity of the research projects, the level of expertise required, and the resources and infrastructure needed to deliver the services. Additionally, take into account the pricing strategies of your competitors and the value you bring to your clients.

You may choose to offer different pricing models, such as fixed project fees, hourly rates, or retainer-based contracts. It is important to clearly communicate your pricing structure to potential clients and highlight the value they will receive in return.

By defining your business model in terms of niche, scope of services, and pricing strategy, you will be able to position your CRO effectively in the market. This clarity will not only attract the right clients but also ensure that you can deliver high-quality services that meet their specific needs.

Remember, your business model is not set in stone and can evolve as your CRO grows and adapts to market demands. Regularly evaluate and refine your business model to stay competitive and meet the evolving needs of your clients.

In the next step, we will explore the process of setting up your CRO, including legal considerations, necessary licenses, and establishing a physical or virtual presence. Stay tuned for Step 3: Setting Up Your CRO.

Step 3: Setting Up Your CRO

Setting up your Contract Research Organization (CRO) is a crucial step in launching your own business in the pharmaceutical and healthcare industry. This step involves various legal considerations, securing necessary licenses and certifications, and establishing a physical location or virtual office. Here’s a detailed guide on how to set up your CRO effectively.

Legal considerations and business registration

Before starting your CRO, it’s essential to understand the legal requirements and regulations that govern the industry. Consult with a legal professional to ensure compliance with local, state, and federal laws. Here are some key legal considerations:

Business structure : Decide on the most suitable business structure for your CRO, such as a sole proprietorship, partnership, limited liability company (LLC), or corporation. Each structure has its own advantages and disadvantages, so choose the one that aligns with your long-term goals and risk tolerance.

Business registration : Register your CRO with the appropriate government authorities. This typically involves obtaining a business license and registering for taxes. Research the specific requirements in your jurisdiction to ensure a smooth registration process.

Contracts and agreements : Develop legally binding contracts and agreements to protect your interests and establish clear terms and conditions with clients, employees, and vendors. Consult with a lawyer to draft these documents to ensure they are comprehensive and enforceable.

Securing necessary licenses and certifications

To operate a CRO, you may need to obtain specific licenses and certifications depending on the services you offer and the regulations in your region. Here are some common licenses and certifications to consider:

Good Clinical Practice (GCP) certification : GCP certification ensures that your CRO follows ethical and scientific standards when conducting clinical trials. It demonstrates your commitment to patient safety and data integrity.

Institutional Review Board (IRB) approval : If your CRO conducts human subject research, you may need to obtain IRB approval. The IRB ensures that research involving human participants is conducted ethically and in compliance with regulations.

Laboratory certifications : If your CRO provides laboratory services, you may need to obtain certifications such as Clinical Laboratory Improvement Amendments (CLIA) certification or accreditation from organizations like the College of American Pathologists (CAP).

Establishing a physical location or virtual office

Decide whether you want to establish a physical location or operate your CRO as a virtual office. Consider the following factors when making this decision:

Physical location : If you choose to have a physical location, consider factors such as accessibility, proximity to research institutions and pharmaceutical companies, and availability of necessary infrastructure. Lease or purchase a suitable space that meets your requirements.

Virtual office : Operating as a virtual office allows you to save on overhead costs and provides flexibility. Ensure you have the necessary technology infrastructure, including secure data storage and communication systems, to support remote work.

Equipment and supplies : Depending on the services you offer, you may need to invest in specialized equipment and supplies. Research the specific requirements for your CRO and budget accordingly.

Setting up your CRO requires careful planning and attention to legal and operational details. By understanding the legal considerations, securing necessary licenses and certifications, and establishing a physical location or virtual office, you can lay a solid foundation for your CRO’s success.

Step 4: Building a Team

Building a strong and capable team is crucial for the success of your Contract Research Organization (CRO). Your team will be responsible for conducting research, managing projects, and delivering high-quality results to your clients. Here are the key steps to building a team for your CRO:

Identifying key roles and responsibilities

Before you start hiring, it’s important to identify the key roles and responsibilities that are essential for your CRO. This will help you determine the specific skills and expertise you need in your team members. Some of the key roles in a CRO may include:

• Project Manager: Responsible for overseeing and managing research projects, ensuring they are completed on time and within budget.
• Clinical Research Associate (CRA): Conducts and monitors clinical trials, ensuring compliance with protocols and regulations.
• Data Manager: Manages and analyzes research data, ensuring accuracy and integrity.
• Regulatory Affairs Specialist: Ensures compliance with regulatory requirements and assists in obtaining necessary approvals.
• Quality Assurance Specialist: Implements quality control measures and ensures adherence to industry standards.

By clearly defining these roles and responsibilities, you can effectively communicate your expectations to potential team members and ensure that you have the right people in place to deliver quality services.

Hiring qualified professionals

Once you have identified the key roles, it’s time to start hiring qualified professionals. Look for candidates who have relevant experience and expertise in the field of clinical research. Consider their educational background, certifications, and previous work experience. Conduct thorough interviews to assess their skills, knowledge, and ability to work in a team.

It’s also important to assess their communication and problem-solving skills, as these are essential for effective collaboration within your team. Look for individuals who are detail-oriented, organized, and have a strong work ethic.

Consider partnering with recruitment agencies or posting job openings on relevant platforms to attract a pool of qualified candidates. Networking within the industry can also help you find potential team members who have a good reputation and track record.

Training and development programs

Once you have hired your team members, it’s important to provide them with the necessary training and development opportunities. This will help them enhance their skills, stay updated with industry trends, and deliver high-quality work.

Develop a comprehensive training program that covers the specific processes and procedures followed by your CRO. Provide training on regulatory requirements, data management, project management, and other relevant areas. Encourage your team members to attend industry conferences, workshops, and webinars to expand their knowledge and network with other professionals.

Investing in the professional development of your team members will not only enhance their skills but also boost their motivation and job satisfaction. This, in turn, will contribute to the overall success of your CRO.

In conclusion, building a strong and capable team is essential for the success of your CRO. By identifying key roles and responsibilities, hiring qualified professionals, and providing training and development opportunities, you can ensure that your team is equipped to deliver high-quality services to your clients. Remember, your team is the backbone of your CRO, so invest time and effort in building a team that is skilled, motivated, and aligned with your organization’s goals.

Step 5: Developing Strategic Partnerships

In the highly competitive Contract Research Organization (CRO) industry, developing strategic partnerships is crucial for the success and growth of your business. By collaborating with pharmaceutical companies, research institutions, industry experts, and associations, you can expand your network, gain credibility, and attract more clients. In this step, we will explore the key strategies to establish and nurture these partnerships.

Collaborating with Pharmaceutical Companies and Research Institutions

One of the most effective ways to build strategic partnerships is by collaborating with pharmaceutical companies and research institutions . These organizations often require the services of CROs to conduct clinical trials, research studies, and data analysis. By positioning your CRO as a reliable and competent partner, you can attract their attention and secure valuable contracts.

To initiate these partnerships, start by conducting thorough market research to identify potential pharmaceutical companies and research institutions that align with your niche or specialization. Reach out to them through networking events, conferences, or direct communication. Highlight your expertise, experience, and the unique value proposition your CRO brings to the table.

When collaborating with pharmaceutical companies and research institutions, it is essential to establish clear communication channels and maintain transparency throughout the partnership. Regularly update your partners on the progress of projects, address any concerns promptly, and deliver high-quality results within the agreed-upon timelines. By consistently exceeding expectations, you can build trust and foster long-term relationships.

Networking with Industry Experts and Associations

Networking with industry experts and associations is another effective way to develop strategic partnerships for your CRO. These professionals and organizations have extensive knowledge and experience in the field, and their endorsement can significantly enhance your credibility and reputation.

Attend industry conferences, seminars, and workshops to connect with experts and professionals in the CRO industry. Engage in meaningful conversations, exchange ideas, and showcase your expertise. Actively participate in industry associations and organizations to gain visibility and access to potential partnership opportunities.

Collaborating with industry experts and associations can also provide access to valuable resources, such as training programs, industry insights, and best practices. By staying updated with the latest trends and advancements, you can position your CRO as a leader in the industry and attract clients who value innovation and expertise.

Building a Strong Referral Network

A strong referral network can be a game-changer for your CRO. By establishing relationships with satisfied clients, industry partners, and professionals, you can leverage their networks to generate new business opportunities. Word-of-mouth recommendations and referrals carry significant weight in the CRO industry, as clients often rely on the experiences and opinions of others when selecting a CRO.

To build a strong referral network, prioritize client satisfaction and deliver exceptional results. Regularly communicate with your clients, address their concerns, and go above and beyond to exceed their expectations. Happy clients are more likely to recommend your services to others and provide testimonials that can attract new clients.

Additionally, foster relationships with other professionals in the industry, such as physicians, researchers, and regulatory experts. Collaborate on projects, share knowledge, and refer clients to each other when appropriate. By nurturing these relationships, you can create a mutually beneficial network that drives growth and success for all parties involved.

In conclusion, developing strategic partnerships is a vital step in launching and growing your CRO. Collaborating with pharmaceutical companies, research institutions, industry experts, and associations can expand your network, enhance your credibility, and attract more clients. By implementing the strategies outlined in this step, you can position your CRO for long-term success in the competitive CRO industry.

Step 6: Marketing and Branding

Marketing and branding play a crucial role in the success of any business, and a Contract Research Organization (CRO) is no exception. In this step, we will explore the key strategies and tactics you can implement to effectively market your CRO and build a strong brand presence in the industry.

Creating a Compelling Brand Identity

To stand out in a competitive market, it is essential to create a compelling brand identity for your CRO. This involves developing a unique value proposition that clearly communicates the benefits and advantages of working with your organization. Consider the following elements when crafting your brand identity:

Mission and Vision : Define your CRO’s mission and vision statements, which will serve as guiding principles for your business. These statements should reflect your commitment to excellence, innovation, and client satisfaction.

Brand Personality : Determine the personality traits you want your brand to embody. Are you reliable, trustworthy, and professional? Or are you more innovative, agile, and forward-thinking? Align your brand personality with the values and expectations of your target clients.

Logo and Visual Identity : Design a visually appealing and memorable logo that represents your CRO’s unique identity. Choose colors, fonts, and imagery that resonate with your target audience and convey professionalism and credibility.

Developing a Website and Online Presence

In today’s digital age, having a strong online presence is crucial for attracting clients and establishing credibility. Here are some steps to develop your CRO’s website and online presence:

Website Design : Create a user-friendly and visually appealing website that showcases your services, expertise, and client success stories. Ensure that your website is mobile-responsive and optimized for search engines to improve visibility.

Content Marketing : Develop high-quality content, such as blog posts, whitepapers, and case studies, that demonstrates your expertise and provides value to your target audience. Share this content on your website and through social media channels to attract and engage potential clients.

Search Engine Optimization (SEO) : Optimize your website with relevant keywords, meta tags, and descriptions to improve its ranking on search engine results pages. This will increase your visibility and drive organic traffic to your website.

Social Media Marketing : Leverage social media platforms, such as LinkedIn, Twitter, and Facebook, to connect with your target audience, share industry insights, and promote your services. Engage in conversations, join relevant groups, and establish yourself as a thought leader in the field.

Implementing Marketing Strategies to Attract Clients

To attract clients and generate leads, it is important to implement effective marketing strategies. Here are some tactics you can employ:

Targeted Advertising : Identify your ideal clients and create targeted advertising campaigns to reach them. Utilize platforms like Google Ads or LinkedIn Ads to display your ads to specific demographics or industries.

Referral Programs : Encourage satisfied clients to refer your services to others by offering incentives or rewards. Word-of-mouth referrals can be a powerful marketing tool in the CRO industry.

Partnerships and Collaborations : Collaborate with pharmaceutical companies, research institutions, and other industry experts to expand your network and gain exposure. This can lead to mutually beneficial partnerships and increased client referrals.

Attend Industry Conferences and Events : Participate in industry conferences, trade shows, and networking events to connect with potential clients and stay updated on the latest trends and developments in the field. Consider speaking at these events to establish yourself as an industry expert.

By implementing these marketing and branding strategies, you can effectively promote your CRO and attract clients. Remember to continuously evaluate and refine your marketing efforts to ensure they align with your business goals and resonate with your target audience.

Step 7: Ensuring Regulatory Compliance

Ensuring regulatory compliance is a crucial step in the success of a Contract Research Organization (CRO). Compliance with industry regulations not only helps maintain ethical standards and data integrity but also builds trust with clients and regulatory authorities. In this step, we will explore the key aspects of regulatory compliance and how to implement them effectively.

Understanding and Adhering to Industry Regulations

The first and foremost aspect of regulatory compliance is understanding and adhering to industry regulations. The CRO industry is highly regulated, and it is essential to stay updated with the latest guidelines and requirements. Regulatory bodies such as the Food and Drug Administration (FDA) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provide guidelines and standards that CROs must follow.

To ensure compliance, it is crucial to establish a robust regulatory intelligence system. This involves regularly monitoring and analyzing regulatory updates, guidelines, and best practices. By staying informed, you can proactively implement necessary changes and ensure that your CRO operates within the legal framework.

Implementing Quality Assurance and Control Measures

Quality assurance and control measures are vital for maintaining regulatory compliance. These measures ensure that the processes and procedures followed by your CRO meet the required standards. Implementing a comprehensive quality management system (QMS) is essential to achieve this.

A QMS includes standard operating procedures (SOPs) that outline the step-by-step processes for various activities within your CRO. These SOPs should cover areas such as data management, document control, project management, and quality control. Regular audits and inspections should be conducted to assess the effectiveness of your QMS and identify areas for improvement.

Additionally, implementing a robust training program for your staff is crucial. Training should cover topics such as regulatory requirements, good clinical practice (GCP), and data integrity. By ensuring that your team is well-trained and knowledgeable, you can minimize the risk of non-compliance and maintain high-quality standards.

Maintaining Ethical Standards and Data Integrity

Maintaining ethical standards and data integrity is of utmost importance in the CRO industry. Clients rely on CROs to conduct research and trials with integrity and transparency. To ensure ethical conduct, it is essential to establish clear guidelines and policies for your CRO.

Data integrity is a critical aspect of maintaining regulatory compliance. It involves ensuring that data generated during research and trials is accurate, complete, and reliable. Implementing data management systems and processes that adhere to industry standards, such as electronic data capture (EDC) systems, can help maintain data integrity.

Furthermore, it is crucial to establish a culture of ethical conduct within your CRO. This includes promoting transparency, accountability, and responsible behavior among your staff. Regular training and communication on ethical guidelines and standards can help reinforce these values.

In conclusion, ensuring regulatory compliance is a vital step in the success of a CRO. By understanding and adhering to industry regulations, implementing quality assurance and control measures, and maintaining ethical standards and data integrity, you can build a reputable and compliant CRO. Compliance not only helps you meet legal requirements but also instills confidence in your clients and stakeholders.

Step 8: Managing Finances

Managing finances is a crucial aspect of running a successful Contract Research Organization (CRO). It involves budgeting, financial planning, pricing services competitively, and tracking expenses and revenue. By effectively managing your finances, you can ensure the financial stability and growth of your CRO. Here are some key steps to consider:

Budgeting and Financial Planning

Creating a budget and financial plan is essential for the smooth operation of your CRO. Start by estimating your expenses, including overhead costs, salaries, equipment, and marketing expenses. It’s important to be realistic and consider both fixed and variable costs.

Next, determine your revenue projections based on your pricing strategy and expected number of clients and projects. This will help you set financial goals and make informed decisions about resource allocation and investment opportunities.

Regularly review and update your budget to reflect any changes in your business operations. This will help you identify areas where you can cut costs or invest more strategically.

Pricing Services Competitively

Pricing your services competitively is crucial for attracting clients and ensuring profitability. Conduct market research to understand the pricing trends in the CRO industry and analyze your competitors’ pricing strategies.

Consider factors such as the complexity of the project, the expertise required, and the value you provide to clients. It’s important to strike a balance between offering competitive prices and maintaining profitability.

You may also consider offering different pricing models, such as fixed fees, hourly rates, or project-based pricing, depending on the nature of the services you provide. This flexibility can attract a wider range of clients and increase your revenue streams.

Tracking Expenses and Revenue

Accurate tracking of expenses and revenue is essential for financial management. Implement a robust accounting system to record all financial transactions and maintain organized financial records.

Regularly review your financial statements, including income statements, balance sheets, and cash flow statements, to gain insights into your CRO’s financial health. This will help you identify any financial inefficiencies or areas for improvement.

Additionally, track your revenue and expenses on a project-by-project basis. This will allow you to evaluate the profitability of each project and make informed decisions about resource allocation and pricing adjustments.

Consider using financial management software or hiring a professional accountant to streamline your financial tracking processes and ensure compliance with tax regulations.

In conclusion, managing finances effectively is crucial for the success of your CRO. By creating a budget, pricing services competitively, and tracking expenses and revenue, you can ensure financial stability and make informed decisions to drive the growth of your business. Remember to regularly review and update your financial strategies to adapt to changing market conditions and optimize your financial performance.

Step 9: Securing Clients and Projects

In the highly competitive Contract Research Organization (CRO) industry, securing clients and projects is crucial for the success and growth of your business. This step focuses on developing a client acquisition strategy, creating compelling proposals and contracts, and building long-term client relationships.

Developing a client acquisition strategy

To secure clients and projects, it is essential to have a well-defined client acquisition strategy in place. Here are some key steps to consider:

Identify your target market : Determine the specific industries, therapeutic areas, or research sectors that align with your CRO’s expertise and services. This will help you focus your marketing efforts and tailor your messaging to attract the right clients.

Build a strong online presence : Develop a professional website that showcases your CRO’s capabilities, experience, and success stories. Optimize your website for search engines to increase visibility and attract organic traffic. Leverage social media platforms and industry-specific online communities to engage with potential clients and establish your credibility.

Attend industry conferences and events : Participate in conferences, trade shows, and networking events to connect with key decision-makers in the pharmaceutical, biotech, and medical device industries. These events provide valuable opportunities to showcase your expertise, build relationships, and generate leads.

Leverage referrals : Encourage satisfied clients to refer your services to their colleagues and industry contacts. Word-of-mouth recommendations can be a powerful tool for acquiring new clients. Consider implementing a referral program that incentivizes clients to refer your CRO to others.

Creating compelling proposals and contracts

Once you have identified potential clients, it is crucial to create compelling proposals and contracts that clearly outline the scope of work, deliverables, timelines, and pricing. Here are some tips to make your proposals stand out:

Tailor your proposals : Customize each proposal to address the specific needs and requirements of the client. Demonstrate your understanding of their research objectives and how your CRO can add value to their projects.

Highlight your expertise : Showcase your CRO’s experience, capabilities, and track record of successful projects. Include case studies, testimonials, and references to build trust and credibility.

Provide a clear pricing structure : Clearly outline the pricing structure, including any additional costs or fees. Offer different pricing options or packages to cater to different client budgets and project requirements.

Emphasize your unique selling points : Differentiate your CRO from competitors by highlighting your unique selling points, such as specialized expertise, advanced technologies, or exceptional customer service.

Building long-term client relationships

Securing clients is not just about winning projects; it is also about building long-term relationships that result in repeat business and referrals. Here are some strategies to foster client loyalty:

Deliver exceptional service : Consistently exceed client expectations by delivering high-quality work, meeting deadlines, and providing excellent customer service. Regularly communicate with clients to keep them informed about project progress and address any concerns promptly.

Maintain open lines of communication : Establish regular communication channels with clients to understand their evolving needs and provide proactive solutions. Actively listen to their feedback and incorporate it into your processes to continuously improve your services.

Offer value-added services : Identify additional services or solutions that can benefit your clients and help them achieve their research goals. This could include data analysis, regulatory consulting, or specialized expertise in a specific therapeutic area.

Seek feedback and testimonials : Regularly seek feedback from clients to gauge their satisfaction and identify areas for improvement. Request testimonials or case studies that highlight the positive outcomes and impact of your CRO’s services.

By implementing a robust client acquisition strategy, creating compelling proposals and contracts, and building long-term client relationships, you can secure clients and projects that contribute to the growth and success of your CRO. Remember, client satisfaction and reputation are key drivers of business growth in the CRO industry.

Step 10: Scaling and Growing Your CRO

As a Contract Research Organization (CRO) entrepreneur, your ultimate goal is to scale and grow your business. This step is crucial for long-term success and sustainability. By expanding your service offerings or entering new markets, you can attract more clients and increase your revenue. Here are some key strategies to help you scale and grow your CRO:

Evaluating performance and identifying areas for improvement

To effectively scale your CRO, it’s essential to regularly evaluate your performance and identify areas for improvement. This involves analyzing your business operations, client satisfaction, and financial metrics. By conducting thorough assessments, you can pinpoint any weaknesses or inefficiencies in your processes and make necessary adjustments. This continuous improvement mindset will enable you to provide better services and attract more clients.

Expanding service offerings or entering new markets

One way to scale your CRO is by expanding your service offerings or entering new markets. This allows you to cater to a wider range of clients and increase your revenue streams. Consider diversifying your services by adding new capabilities or specialties that align with industry trends and client demands. Additionally, explore opportunities to enter new geographical markets where there is a high demand for CRO services. This expansion can significantly contribute to the growth of your business.

Investing in technology and innovation

To stay competitive and facilitate growth, it’s crucial to invest in technology and innovation. Embrace digital solutions that streamline your processes, enhance data management, and improve efficiency. Implementing electronic data capture systems, cloud-based platforms, and artificial intelligence tools can revolutionize your operations and provide a competitive edge. By staying at the forefront of technological advancements, you can attract more clients and position your CRO as a leader in the industry.

Scaling and growing your CRO requires careful planning, strategic decision-making, and continuous adaptation to market trends. By evaluating your performance, expanding your service offerings or entering new markets, and investing in technology and innovation, you can position your CRO for long-term success.

Remember, scaling a business takes time and effort. It’s important to be patient and persistent in your pursuit of growth. Stay focused on providing exceptional services, building strong client relationships, and staying ahead of industry developments. With dedication and the right strategies in place, your CRO can thrive and make a significant impact in the field of clinical research.

In conclusion, launching and growing a Contract Research Organization (CRO) requires careful planning, strategic decision-making, and continuous adaptation to market trends. By following the step-by-step guide outlined in this article, you can establish a successful CRO and position it for long-term growth. From understanding the CRO industry and defining your business model to building a team, developing strategic partnerships, and ensuring regulatory compliance, each step is crucial for your CRO’s success. Remember to evaluate your performance, expand your service offerings or enter new markets, and invest in technology and innovation to scale and grow your CRO. With determination, perseverance, and a commitment to excellence, you can build a thriving CRO that contributes to advancements in clinical research. Good luck on your entrepreneurial journey!

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Guide to Choosing & Collaborating with a CRO

Last Updated on 

January 19, 2023

In the life sciences industry, the name of the game is often getting through preclinical studies and clinical trials. However, this feat is easier said than done. Many biotech, biopharma, pharma, and medical device companies need support to successfully conduct studies and trials.

Not every organization has the in-house capabilities, resources, and time to perform every trials-related task effectively and efficiently. When this is the case, businesses can rely on contract research organizations (CROs) for support with different stages of research and development.

This guide to CROs will help biotechnology, biopharmaceutical, and pharmaceutical companies select and collaborate with the right contract research organization, ensuring teams understand how CROs work, how to pick a good partner, and how to get full value out of these partnerships.

We’ll also review when it can make sense to lease lab equipment for in-house research and development alongside or in place of working with a CRO.

Need new or refurbished lab equipment? Excedr leases.

See our equipment list and browse a sample selection of what we can source. Or, if you’re ready, request an estimate.

What Is a Contract Research Organization?

A CRO is an individual or team that provides research services on a contract basis to other organizations in the life sciences, including pharmaceutical companies, biotechs, biopharmas, medical device companies, and even research institutions, government agencies, and foundations.

The services CROs provide to help develop drugs, medical devices, biologics, and other healthcare-based products include clinical trial support, laboratory testing, regulatory support, and more. Which services an organization or team offers will depend on their areas of focus and expertise, as well as the organization’s size and capabilities.

Outsourcing certain tasks and duties can allow companies to skip maintaining staff for these functions while still moving a drug or device from conception and development to FDA approval.

Contract research organizations typically work on a contract basis, providing services for specific projects or for a set period of time. This business model is designed to reduce drug development costs for companies and simplify entry into drug markets, and usually present a cost-effective alternative to in-house research and development for a wide variety of research-based labs and organizations that do not have the resources or expertise needed to perform certain research tasks on their own.

Working with a CRO can be an effective and efficient option if you’re working towards getting a product to market, but unsure if you want to take on the financial costs of building out an entire research team in addition to acquiring the necessary equipment and facilities to perform the tasks related to your clinical trials in-house.

In addition to a variety of services, CROs range in company size. This means, depending on your needs, you can find a small, specialized group or a larger, full-service organization that can handle all aspects of conducting research and clinical trials.

CROS will also carry out all of its work according to Good Clinical Practices (GCPs) that ensure high-quality studies and full compliance throughout your preclinical studies and clinical trials.

What Types of Services Do Contract Research Organizations Provide?

CROs offer a wide range of services to support the pharmaceutical, biotechnology, and medical device industries, from project, data, and site management, to clinical study management, research compliance and education, medicine and disease coding, validation, product development and commercialization, quality control, biostatistics, and much more.

Depending on the organization, the list can be quite extensive. Review the exact services each can provide. Understanding your requirements first and then assessing the scope of their services and resources needed can help you find a contract research organization that’s right for you.

Providing Laboratory Testing Services

CROs can provide specialized laboratory testing services, such as toxicology testing, microbiology testing, and pharmacokinetic studies. These services help companies assess the safety and efficacy of their products.

Supporting the Regulatory Process

Contract researchers can assist with the regulatory process and quality assurance, including preparing and submitting regulatory documents, such as registration and marketing applications, and providing guidance on compliance with regulatory requirements.

Conducting Preclinical Research

Contract researchers can also support drug discovery, product development, and conduct preclinical research on the safety and efficacy of new drugs, medical devices, and other products. This research typically involves animal testing and helps companies assess the potential risks and benefits of their products before they are tested in humans.

Conducting Clinical Trials

CROs can help design and manage clinical trials on behalf of other companies, from the initial planning stages to the analysis of the results. This may involve recruiting participants, collecting data, and monitoring the progress of the trial. When an organization offers clinical trial services and support, they might refer to themselves or be referred to as a clinical research organization.

Additional Research & Development Services

In addition to the services above, CROs can even help with other areas of research, including formulation development, process development, and analytical testing. These additional services can help laboratories improve the quality and effectiveness of their products.

What Types of Contract Research Organizations are There?

There are numerous types of CROs actively supporting the life sciences today. Their differences can range from the level of specialization—which types of studies they specialize in—the types of services they offer, company location or size, and much more.

Some organizations offer end-to-end services, providing support with preclinical studies, phase I, II, and III clinical research, and even commercialization They also tend to have expertise in a wider variety of therapeutic areas. Others tend to specialize in a certain stage of research and development, or may have expertise in a specific therapeutic area or industry.

Below are a few examples of different ways you can categorize contract research organizations.

Clinical Research Organizations

Clinical research organizations are CROs that specialize in conducting clinical trials on behalf of a client. They are usually responsible for designing the trial, recruiting participants, collecting data, and analyzing the results. In other words, they will handle clinical trial planning, data management, project management, site management, and trial monitoring.

These types of organizations can differ from other CROs who might provide services outside of clinical trials. Simply put, a contract research organization provides support to companies through a broad range of research support services, including study design, data management, and statistical analysis. These services can sometimes fall outside of clinical research and trials.

Laboratory Testing Organizations

Laboratory testing CROs provide specialized laboratory testing services, and may not provide clinical trial support. Instead, they’ll likely focus on a specific type of testing, such as toxicology or microbiology, or offer a range of services related to testing your product for a variety of reasons.

Regulatory Affairs Organizations

Some CROs specialize in regulatory affairs. This means they can provide support with a variety of the regulatory processes pharmaceutical, biotechnology, and medical device companies have to undertake and comply with. They can typically help companies prepare and submit regulatory documents, such as registration and marketing applications, and provide guidance on compliance with regulatory requirements.

Preclinical Research Organizations

Preclinical research CROs can help conduct research on the safety and efficacy of new drugs, medical devices, and other products before they are tested in humans during clinical trials. This type of research can involve animal testing and relies on a range of techniques, such as toxicity testing and pharmacokinetic studies. Some CROs that specialize in preclinical research can also help you when it comes time to conduct clinical trials, and vice versa.

How Are CROs Staffed?

Contract research organizations are staffed by a range of professionals with expertise in the pharmaceutical, biotechnology, and medical device industries. This can include clinical research professionals, laboratory technicians, regulatory affairs managers, preclinical research associates and scientists, and much more.

Clinical Research Professionals

Clinical research professionals, such as clinical research associates, clinical trial coordinators, and clinical trial managers, are responsible for planning, conducting, and managing a client’s clinical trials.

Regulatory Affairs Professionals

CROs that provide support with the regulatory process employ regulatory affairs professionals to help prepare and submit various regulatory documents. Regulatory affairs associates and managers can also provide guidance on compliance with different regulatory requirements the client will face.

Lab Professionals

Some CROS may employ laboratory professionals that are responsible for conducting tests and analyzing results. This can include laboratory technologists and technicians.

Preclinical Research Professionals

CROs that conduct preclinical research typically employ preclinical research professionals, such as preclinical research associates and preclinical research scientists. Like a clinical research coordinator or associate, these staff members are responsible for designing and conducting a client’s preclinical studies.

Additional Research & Development Professionals

In addition to various research associates, technicians, managers, and coordinators, CROs may also employ other types of R&D professionals. This can include formulation scientists, process engineers, and analytical chemists, who provide specialized research and development services for clients.

When Should You Use a Contract Research Organization?

There are several situations in which it can make sense to use a CRO to help with your business: lack of expertise or resources and cost or timeline inefficiencies are just two important reasons.

If you do not have the expertise or resources to conduct research and development in-house, CROs can provide the specialized expertise and resources needed to accelerate your research and fill in the gaps. This can be especially useful if you are a small company or if you are entering a new market or product area.

If you need to outsource research and development activities to save time and money, a contract researcher can—depending on the fees the organization charges—provide cost-effective R&D support, freeing up your team to focus on other tasks. Outsourcing can help you save time and money, and potentially help you get to market faster.

If you need support with the regulatory process, a contract research organization can provide guidance and support throughout the regulatory process, including preparing and submitting regulatory documents. With proper regulatory support, you’ll ensure you are in compliance with regulatory requirements and avoid costly delays or mistakes.

If you need to conduct clinical trials but lack the resources to do so, a CRO can design and manage the clinical trials on your behalf, from the initial planning stages to analysis of the results, making it easier to effectively and efficiently gather the data you need to support the safety and efficacy of your products.

Or, if you need to conduct preclinical research, a contract service provider can help conduct preclinical research on your products to assess their safety and efficacy before you go to clinical trials. Working with a CRO during your preclinical studies can help you more effectively identify any potential risks or benefits before moving on to test in humans, potentially saving you time and money in the long run.

How Do You Choose a CRO to Work With?

When it comes time to choose a CRO to partner with, there will be several factors you’ll want to consider, including their level of organizational expertise and experience, the quality and compliance of their work, the cost and value for money, the organization’s ability to communicate and collaborate, and its timeliness and flexibility.

You will also need to find a contract research organization that has a proven track record supporting R&D in your specific therapeutic area or industry. Working with a contractor that doesn’t have experience doing so may inevitably lead to failure in preclinical or clinical research.

Expertise & Experience

The CRO should have extensive expertise and experience in the specific area you are looking for support in, whether it’s conducting clinical trials or running laboratory tests. It can be helpful to look at each organization’s track record or the types of clients they have worked with in the past to assess their level of expertise.

Quality & Compliance

The organization should demonstrate a strong commitment to quality and compliance, and should be able to provide evidence of their compliance with relevant regulations and standards. Like assessing their track record or client list, you can review a CRO’s quality management system and any certifications they have, such as ISO 9001 certification, to determine their levels of quality and compliance.

Cost & Value for Money

A contract researcher’s fees should be competitive and provide real value for money. In other words, the fees you pay should align with what you receive in return. To assess whether or not the organization’s worth their prices, you can sometimes ask for cost estimates for the services you are interested in and compare them to other CROs.

Communication & Collaboration

The CRO should be able to communicate effectively and collaborate with your team throughout the project. Poor communication and collaborative efforts can result in poor results and failed trials, so it’s important to establish whether or not the CRO is a strong communicator. If possible, you can ask for references from other clients and to speak with the CRO’s team directly to assess their communication and collaboration skills.

Timeliness & Flexibility

An organization should also be able to deliver the services you need in a timely manner and should be flexible enough to adapt to any changing needs or requirements. Ask about the CRO’s availability and their approach to managing project timelines to get a better idea of whether or not they can meet deadlines and remain flexible in the face of changes.

Facility Locations

A CROs location can also be an important consideration when selecting a partner. If the drug or device you are developing together is expected to be approved in a variety of nations or locations, it will be beneficial—perhaps even necessary—to hire a CRO that has experience with the approval process in each location.

They may have facilities and staff positioned in the target location and will have knowledge about local regulations for clinical studies and approval.

Furthermore, because you’re outsourcing the work, you can easily lose oversight of the project. When a CRO’s team is conducting day-to-day tasks in another location, supervision can be more difficult, or even impossible.  Comparing global CROs and local CROs and assessing how much supervision will be needed can help you understand whether or not location will be important in your selection.

Advantages & Disadvantages of Working with a CRO

Similar to working with a contract manufacturing organization (CMO), there are several advantages and disadvantages to working with a contract research organization.

The decision to use a CRO should be carefully considered, taking into account the potential drawbacks as well as the potential benefits.

• CROs have expertise and resources that may not be available in-house, such as specialized laboratory equipment or regulatory affairs experts. This can help you access the knowledge and capabilities you need to conduct research and development effectively.
• They can provide cost-effective support for research and development tasks, saving you time and money compared to conducting these activities in-house.
• They provide services on a contract basis, which can be more flexible than hiring permanent staff. This is especially useful if you have a specific project or a short-term need for research and development support.
• They typically have a strong commitment to quality and compliance, and are typically subject to strict regulatory requirements. This can help you ensure that your research and development activities are conducted according to the highest standards.
• They can often help you get to market faster by providing timely support for research and development activities, helping you stay ahead of the competition and capitalize on new opportunities.
• Using a CRO can sometimes be more expensive than conducting research in-house, as CROs typically charge a fee for their services.
• You may have less control over the research process, as the CRO will be responsible for conducting the study and collecting the data.
• If communication is poor, it can lead to misunderstandings and delays. Effective communication and collaboration between your company and the CRO is essential for the success of the research project.
• The quality of the research conducted by a CRO may vary depending on the experience and expertise of the individual CRO. It is important for the sponsoring company to carefully evaluate the CRO’s qualifications and track record before engaging them.

Lease with Excedr to Support In-House Research

Biotechnology, biopharmaceutical, and pharmaceutical companies often need support when it comes to preclinical, clinical trials, and other areas of research and development. There are a wide range of tasks, and not every company has systems and staff in place for every task or step.

However, rather than conduct the research in-house—spending the money to build out a team and acquire the necessary facilities and equipment and securing all the necessary compliance certifications—laboratories can outsource the research to contract research organizations.

CROs come in quite handy when startups, small- and medium-sized businesses, and even large enterprises need to increase R&D efficiencies and decrease the time and cost to approval and market. Using a CRO, on the other hand, can be a good option if you don’t have the expertise or resources to conduct the research yourself, or if you need access to specialized equipment or facilities.

CROs typically have extensive experience and expertise in conducting research studies, and can provide a range of services, including study design, data management, and statistical analysis.

However, using a CRO can be more expensive than conducting the research in-house, and you may have less control over the research process. If you do conduct research in-house, you will undoubtedly need to keep a variety of high-quality research equipment on-hand to gather and manage your data.

Not having the proper lab equipment, as you well know, can greatly affect the results of your work, making it necessary to keep up with technology and equip your lab with the right instrumentation.

Leasing lab equipment with Excedr can be a cost-effective option for life sciences and biotech companies when you want to reduce the upfront costs on the equipment, protect it with comprehensive service coverage, and remain flexible when a new and better technology inevitably becomes available.

Rather than sink your money into a fixed asset and take a huge chunk out of your R&D budget, leverage our leasing program instead. Doing so is an excellent choice when or if you need a specific piece of equipment that you don’t have in-house, or if you need to expand your existing laboratory facilities.

Home >   Contract Research Organization

Contract Research Organization

A contract research organization (CRO), also called a clinical research organization, is a service business that provides outsourced clinical study and clinical trial support to life sciences companies. CROs also support non-profit organizations, foundations, research institutions, universities, and government and non-government organizations.

CROs specialize in consulting services for pharmaceutical, biotech, and medical devices. They range from large, international, full-service organizations to small, niche, specialty businesses. 

Contract research organizations provide life sciences companies with experience and expertise for parts of or all of the work required to move a drug or medical device from ideation through regulatory approval processes (e.g., Food and Drug Administration or FDA, European Medicines Agency or EMA).

Let’s jump in and learn:

• Regulatory Aspects of CROs
• How Contract Research Organizations Work
• Types of Services at Contract Research Organizations
• Pros and Cons of Contract Research Organizations
• Tips for Working with a CRO
• Contract Research Organizations Provide Elasticity

Three criteria for selecting a CRO include:

• 1. Capability
• 2. Compatibility

In some cases, CROs assume responsibility for regulatory aspects of a clinical trial or clinical study. Sponsors may transfer any or all clinical trial tasks and obligations to CROs through a Transfer of Regulatory Obligations (TORO). Based on obligations detailed in a contract, the regulatory aspects of CROs include being held responsible for any sponsor obligations it assumes for studies conducted under an investigational new drug application.

Regulations and guidelines set forth by both the FDA and ICH-GCP define how sponsors engage with CROs and associated responsibilities.

Food and Drug Administration (FDA)

Code of Federal Regulations - Title 21 - Food and Drugs (21 CFR) Sec. 312.52 Transfer of obligations to a contract research organization.

• A sponsor may transfer responsibility for any or all of the obligations set forth in this part to a contract research organization. Any such transfer shall be described in writing. If not all obligations are transferred, the writing is required to describe each of the obligations being assumed by the contract research organization. If all obligations are transferred, a general statement that all obligations have been transferred is acceptable. Any obligation not covered by the written description shall be deemed not to have been transferred.
• A contract research organization that assumes any obligation of a sponsor shall comply with the specific regulations in this chapter applicable to this obligation and shall be subject to the same regulatory action as a sponsor for failure to comply with any obligation assumed under these regulations. Thus, all references to "sponsor" in this part apply to a contract research organization to the extent that it assumes one or more obligations of the sponsor.

International Conference on Harmonization (ICH)’s Good Clinical Practice: Consolidated Guideline (ICH-GCP)

• (5.2.1) A sponsor may transfer any or all of the sponsor's trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should implement quality assurance and quality control.
• (5.2.2) Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in writing. The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor's contracted CRO(s).
• (5.2.3) Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the sponsor.
• (5.2.4) All references to a sponsor in this guideline also apply to a CRO to the extent that a CRO has assumed the trial-related duties and functions of a sponsor.

A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions. ICH-GCP (E6 1.20) definition of a Contract Research Organization (CRO)

Life sciences companies increasingly engage contract research organizations to complement, augment, or use in place of internal teams. By outsourcing this function, drug or device sponsors do not have to maintain and manage staff for key functions, including discovery, preclinical, clinical, and laboratory services. How contract research organizations work with sponsor organizations varies by project.

Three ways that sponsor organizations commonly use contract research organizations are:

• 1. Maximum outsourcing The CRO is used for nearly all of the clinical development activities.
• 2. Strategic outsourcing The sponsor conducts phase I and early phase II studies, and the CRO is engaged to conduct follow-on studies.
• 3. Tactical outsourcing Sponsors use the CRO for individual studies or specific parts of a study.

Contract research organizations offer everything from end-to-end, full-service offerings to niche services focused on a particular type of work or distinct therapeutic area. Some sponsors use CROs to initiate and monitor clinical trials, while others have them take responsibility for running the trial in its entirety.

Following are several of the many types of specific services available from contract research organizations.

• Biologic assay development
• Biopharmaceutical development
• Biostatistics
• Case report forms
• Clinical monitoring
• Clinical research
• Clinical trial management
• Commercialization
• Data management
• Data research
• Identify and address adverse events
• Formulation development
• Logistics management
• Medical writing, including study documentation
• Pharmacokinetic studies
• Pharmacovigilance
• Preclinical research
• Preparation and submission of regulatory materials 
• Project management
• Protocol design
• Recruitment support
• Regulatory affairs
• Sample selection
• Site management
• Site selection and activation
• Stability programs
• Trial logistics

Pros of Contract Research Organizations

• Allows sponsors to focus on their core business 
• Bring proven people, processes, and equipment to support all phases of trials
• Come prepared to start work as soon as a contract is signed—no delays related to hiring or set up
• Know the best clinical sites and investigators in a specific region to ensure high patient enrollment rates
• Offer experience and local knowledge of regulations and approval processes in a variety of nations and locations 
• Provide ready access to resources needed to conduct a clinical trial 
• Saves sponsors money ramping up for and running clinical trials 

Cons of Contract Research Organizations

• Exposure to significant regulatory risks because sponsors are ultimately responsible for the quality and integrity of the trial data 
• Have to conduct multiple audits before and during every step of the trial
• Lack of direct oversight with a team that is in another location 
• Requires sharing intellectual property and other confidential information with an outside organization
• 1. Agree on performance metrics to measure progress and quality.
• 2. Clarify roles and responsibilities—specify which tasks will be performed in-house and which by the CRO.
• 3. Clearly define realistic timelines for start, duration / end data, as well as timing for key milestones.
• 4. Conduct audits throughout the study.
• 5. Create an accurate and detailed list of activities required to initiate, conduct, analyze, and report the results of a clinical study.
• 6. Define content and format requirements for various reports (e.g., status reports, interim analysis reports, final report).
• 7. Establish communication channels and protocols between internal teams and the CRO’s teams.
• 8. Assign dedicated internal resources to manage the study.
• 9. Identify key contacts on both sides.
• 10. Treat the CRO as a partner.

CROs have become a fundamental part of clinical trials because they offer a wide range of services to support all phases. Sponsor organizations have the option of outsourcing studies to CROs or using point solutions to fill gaps or leverage unique expertise.

The CRO’s knowledge and experience can help sponsors reduce workload and expedite trials. Partnering with contract research organizations has proven beneficial to life sciences organizations of all sizes.

Egnyte has experts ready to answer your questions. For more than a decade, Egnyte has helped more than 16,000 customers with millions of customers worldwide.

Last Updated: 10th October, 2021

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How to Start a Clinical Research Contracting Business

by Roy Sylvan

Published on 26 Sep 2017

Opportunities for startup clinical research companies are more prevalent in niche areas not covered by large clinical research organizations (CROs). Your smaller company can best succeed by locating individuals or small development companies with new pharmaceuticals, nutriceuticals, medical and dental devices requiring clinical testing before they can be marketed. Pharmaceutical corporations pass on many testing opportunities because they calculate their profit will not exceed development costs. Large CROs frequently refuse these same projects if the product developer doesn’t have the capital to pay their fees. CROs and pharmaceutical manufacturers know that more than 80 percent of products they test never make it to market.

Business plan

Marketing plan

Professional staff

Support staff

Develop a business plan. Your plan needs a statement of the legal structure and describes how you intend to operate. It should include the qualifications of the major personnel who will supervise the research, your understanding of the market opportunity, competition and financing needs.

You may want to incorporate to protect yourself, corporate officers and the board of directors from legal liability. A person or company hiring your firm to do their clinical studies may sue you for a variety of shortcomings, including incompetence, if your test findings show their product to be ineffective.

Your qualifications and those of other employees, including your board members, give investors, banks and potential clients confidence in your startup’s capacity to succeed. Find the best people available. A stirring rod broken by a careless technician can ruin a batch of test material that may take a month and thousands of dollars to replace.

How large an office and how much staff you need depends on the clients you obtain. Conducting a clinical trial requires professional staff to collate input from physicians who examine study participants. You will need record keeping personnel, computer technicians, office and accounting staff. Plan for hiring technical employees and consultants, including statisticians, doctors and pharmaceutical scientists.

Create a realistic marketing strategy that accounts for the number, size and specialties of your competitors. Make trips to scientific conferences, visits with research companies and laboratories that may be able to give you leads on newly developing potential products. Explore product areas where profits may be small enough that larger competitors may not pursue them.

Thoroughly research the financial needs of your business venture. You will require substantial amounts of money to put in place the infrastructure needed to become a viable CRO. One way to obtain that infrastructure is to get a client to help underwrite cost. Investors, venture capitalists and banks may help if you present a good business plan.

Always protect yourself and your company with sufficient insurance.

What Is a CRO?

Pharmaceutical, biotechnology and medical device companies initiate, manage and fund clinical trials and are ultimately responsible for the clinical trial process. They are referred to as sponsors. Clinical trial sponsors also include government agencies, such as the National Institutes of Health (NIH) in the United States, and non-profit organizations.

The research and development process for a single drug can require the participation of thousands of people. It may take as long as 15 years to bring a new drug to market and the average cost can exceed $1 billion. It is a long, complex and expensive process, and many sponsors are not equipped, resourced or prepared to perform all trial-related duties and functions themselves.

For this reason, sponsors may choose to outsource all or part of the trial-related tasks to a company called a clinical research organization or contract research organization (CRO) to manage the clinical trial on their behalf, without sponsors having to maintain a staff for these services. CROs have the capacity to conduct the day-to-day research activities that are either not possible or too expensive for a sponsor to achieve in-house. CROs are experts in the space and active partners in clinical research.

• A CRO's Role in Pharmaceutical Development
• Functions of a CRO
• Clinical Research and Trial Management
• Global and Specialized CRO Services

“ It may take as long as 15 years to bring a new drug to market and the average cost can exceed $1 billion . “

CROs in the United States

the size that the global CRO market size is expected to reach, in dollars, in 2023

What Is a CRO’s role in pharmaceutical development?

CROs play a major role in ensuring safe, ethical clinical trials that are essential to developing new, life-changing drugs and medical devices that benefit millions of patients worldwide .

The services that a CRO may offer can cover the full timeline of the study:

• The development and revision of protocols for trials
• The adaptation of the necessary documentation to the applicable rules
• Obtaining the necessary approvals from clinical research ethics committees and regulatory authorities
• The design and preparation of case report forms
• The determination of the sample
• The selection of the best researchers and research centers
• The final negotiation of the contracts among all parties (the CRO, vendors and sites).
• Once regulatory approval is obtained and the trial begins with site selection and patient recruitment, the CRO can provide monitoring , which consists of controlling compliance with the protocol and the procedures established for the development of the study. Likewise, pharmacovigilance services include detection and action in case of any adverse event (AE).
• The last steps to ensure the success of any clinical study are the statistical analysis and management of the trial data , the generation of reports (including the clinical study report for submission to regulatory authorities for drug approval) and the control and storage of the documentation.

CRO structure

A Contract Research Organization (CRO) acts as a bridge between the sponsor, the one who contracts the services, and the rest of the actors involved in the clinical trial.

(Leon Research, https://leonresearch.com/what-is-a-cro-and-how-can-it-help-you-in-your-clinical-trial/ )

Functions of a Clinical Research Organization

Typically, a CRO provides scientific, clinical and business continuity for clinical trial sponsors. The CRO can be involved in a range of services from pre-clinical research (which takes place before human trials) to post-marketing surveillance (which takes place after a product has been approved for use).

Other administrative activities may include strategic consulting and protocol development, laboratory and analytical services, project management, trial logistics, medicine and disease coding, statistical analysis and reporting, validation programming, safety and efficacy summaries and the final study report.

Clinical research and trial management

A sponsor hires a CRO to plan, coordinate, execute and manage the life cycle of the clinical trial safely and efficiently. Serving as the main contact between the sponsor and other stakeholders throughout the trial, the CRO communicates with ethics and compliance committees, regulatory personnel, vendors, physicians and research coordinators.

Clinical trials conducted by CROs are completed on average 30 days faster than those conducted by sponsor companies. 1

Every day counts for both patients (who may be anxiously waiting on therapies that could improve or even save their lives) and sponsors (because time spent in the development process counts against the patent protection period after the drug goes to market, affecting sales revenue).

With more than 35 years of experience, the PPD clinical research business of Thermo Fisher Scientific offers an established drug development platform, patient enrollment expertise and robust laboratory services . Our broad range of clinical development, analytical and patient and advisory services – including full service to functional service provider services , digital and decentralized trials, and laboratories – enables customers to drive innovation and increase drug development productivity. We are recognized for accelerating promising medicines from early development through regulatory approval and market access. Our flexible, custom-tailored solutions serve pharmaceutical, biotech, medical device, academic, government and public health organizations in clinical research and development .

Global and specialized CRO services

Most large CROs are full-service, providing complete clinical trial management support, but there are some companies specializing in a specific type of study (e.g., research with medical devices or observational studies) and also CROs specializing in a specific therapeutic area, such as oncology or ophthalmology.

Global CROs, large companies with operations all over the world, provide greater, integrated geographical coverage, with more service offerings and capabilities, while local companies may sometimes have more in-depth knowledge of a particular country’s nuances and demographics as they relate to clinical development.

The global network consisting of clinical sites within the PPD clinical research business of Thermo Fisher Scientific and non-owned partner sites offers access to a diverse pool of healthy volunteers and specialty populations around the world. Our experienced staff provides external oversight of a trial, working directly with the institutions where clinical studies are conducted – hospitals and clinics, called investigational sites. We provide training to the principal investigator and the site staff, and ensure that the safety, rights and well-being of patients are protected; that the conduct of the trial is in compliance with regulatory requirements; and that reported trial data are accurate and complete.

What is the difference between a CRO and a sponsor?

Although the sponsoring company may transfer the trial functions to a CRO, the sponsor owns the investigational product and needs to ensure results are factual and scientifically backed. 

According to the definition of the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) , a CRO is: “A person or an organization (commercial, academic or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions.” 

The sponsor maintains a central role throughout the clinical trial process. Although regulatory tasks differ globally, they include initiating the trial process by submitting an application and ensuring approval is obtained (directly or indirectly).

The ICH Guideline for GCP specifies the responsibilities a CRO can take over from a sponsor : 

• 5.2.1: A sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should implement quality assurance and quality control.
• 5.2.2: Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in writing. The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor’s contracted CRO(s).
• 5.2.3: Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the sponsor.
• 5.2.4: All references to a sponsor in this guideline also apply to a CRO to the extent that a CRO has assumed the trial-related duties and functions of a sponsor.

What are the advantages of outsourcing to a CRO?

A CRO can offer substantial cost savings for a sponsor by reducing the time it takes to conduct a trial compared to a sponsor doing so in-house. This also eliminates the need for staff, infrastructure and lab and office space for the sponsor to run the trials themselves. Finally, a full-service CRO can provide access to a global network of clinical research sites, meaning it can quickly identify suitable sites for clinical trials in multiple countries. Geographical reach or therapeutic focus can be important in patient recruitment, especially in specific populations, such as underserved and diverse , or for rare diseases that affect a small subset of people.

Working with a CRO gives sponsors access to the most advanced technology and systems for data management, product development, research analysis and other clinical research services. CROs are quick to adopt the latest technologies, enabling them to provide strategic insights and advice, and to offer novel and distinctive ways to use advanced tools and adapt them to each sponsor’s needs to ensure optimal clinical trial performance. Given that CROs work with many different sponsors, they often have a breadth of experience beyond even a single large pharmaceutical company.

CROs adhere to clinical compliance on a daily basis, which requires intricate in-house knowledge of regulatory requirements and audits such as GCP (Good Clinical Practice) or GLP (Good Laboratory Practice) audits.

Sponsors conducting clinical research in a niche area such as rare disease may choose to work with a specialty CRO or a global CRO with offering such services.

Global Network

The PPD clinical research business of Thermo Fisher Scientific has an extensive global network of investigators, clinicians and partners with a wide range of products, technologies and services that can be leveraged for clinical trial conduct. Our goal is to deliver considerable time and cost savings in drug development, critical to accelerating the delivery of life-changing therapies. Our experts consider the end before the beginning by envisioning and planning for commercialization and market acceptance well before the first patient is enrolled in a clinical trial. And before trials are underway, we design for post-approval, real-world patient observation that provides support for payer authorizations and may lead to new ideas and products .

How does a sponsor select a CRO?

When selecting a CRO, here are some questions to consider:

• Can the CRO offer the services that the sponsor needs?
• Does the CRO have related experience and a good track record (i.e., similar projects and references or testimonials from satisfied clients)?
• Is the CRO financially stable?
• Does the CRO have a good system for employee training and a low staff turnover rate?
• Does the CRO have the key staff members required and can it set up a team to deliver qualified results?
• Does the CRO have the required infrastructure?
• Does the CRO have a robust quality assurance system?
• Is the CRO’s team responsive and willing to work with you and communicate throughout the project?
• Does the CRO have specialty services, laboratories, digital and decentralized solutions, a clinical supplies network and other capabilities important to your drug development program?
• Will the CRO help you recruit and manage safety boards or committees?
• Will the CRO conduct audits to help you prepare to pass FDA inspections?
• Can the CRO provide general site support and project management help in addition to clinical monitoring?
• Does the CRO function as a vendor or a true partner ?

Drive your drug development program forward

Partner with a leading, global CRO that leverages a proven track record and deep expertise to keep the patient at the forefront of your trial.

The PPD clinical research business of Thermo Fisher Scientific accelerates your success with a dynamic, forward-thinking approach, a comprehensive suite of capabilities and true partnership with our customers.

What can Lindus Health do for your study?

How to set up a contract research organization (cro), how to set up a contract research organization (cro): a comprehensive guide.

In the world of life sciences, bio-pharmaceuticals, and medical device development, Contract Research Organizations (CROs) play a pivotal role. Their services ranging from research and development, preclinical and clinical trials, to regulatory support and compliance solutions are instrumental for businesses. But, the question arises: How to set up a contract research organization that stands out in the market? Let's delve into the details.

Understanding Contract Research Organizations

A Contract Research Organization (CRO) is a company that provides research services to other entities in the life science sector, including pharmaceuticals, biotech, medical devices, and even research institutions, on a contractual basis. They help businesses expedite the process of preclinical studies, drug development, and clinical trials, thereby saving time, resources, and money.

Types of CROs

CROs are classified based on the services they offer and their focus areas. Some CROs are full-service, offering end-to-end support for preclinical studies, clinical trials, and commercialization. Others specialize in specific areas like clinical research, preclinical research, laboratory testing, or regulatory affairs.

Analyzing the Need for a CRO

The decision to set up a CRO should be based on understanding the market needs. Many companies lack the resources or expertise to conduct certain research tasks. In such cases, outsourcing these tasks to a CRO becomes a cost-effective and efficient solution.

Laying the Foundation: Planning

The first step in setting up a CRO is planning. This includes defining the CRO's scope, identifying the services to be offered, deciding the location, and estimating the initial costs. This stage also involves understanding and complying with the regulatory requirements like Good Clinical Practice (GCP) and the Clinical Trial Directive.

Infrastructure and Equipment

The next step involves setting up the physical infrastructure. This includes finding a suitable location, designing the space as per GMP requirements, and procuring the necessary laboratory equipment. It's essential to choose a location considering factors like environmental infrastructure and cost.

Building a Competent Team

A CRO is as good as its team. It's crucial to hire skilled professionals with expertise in the pharmaceutical, biotechnology, and medical device industries. This may include clinical research professionals, laboratory technicians, regulatory affairs managers, preclinical research associates and scientists, and more.

Regulatory Compliance and Certification

A crucial aspect of setting up a CRO is complying with the regulatory requirements and obtaining the necessary certifications. This includes preparing and submitting regulatory documents and ensuring compliance with GCP and other regulations.

Developing a Training Plan

To ensure high-quality service, a robust training plan for the staff is essential. This plan should focus on enhancing the technical and managerial skills of the employees and should be dynamic to accommodate changes in the industry.

Costing and Investment

Setting up a CRO requires substantial investment. This includes the cost of infrastructure, equipment, salaries of the employees, regulatory certifications, and more. It's essential to have a clear financial plan and secure the necessary funding.

Marketing and Client Acquisition

Once the CRO is set up, the next step is to market the services and acquire clients. This can be achieved through networking, attending industry events, digital marketing, and more.

Continuous Improvement and Scaling Up

As the CRO grows, it's essential to continuously improve the services, invest in employee training, and scale up the operations. This will help the CRO stay competitive and meet the changing needs of the clients.

In conclusion, setting up a contract research organization involves careful planning, investment, and continuous effort. However, with the right approach, it can prove to be a profitable venture that contributes significantly to the advancement of life sciences.

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CATEGORY GUIDE

Cro contract research organisations explained: a guide to cros.

An overview of the Contract Research Organisation (CRO) market and its significance in the pharmaceutical and biotech industries.

This guide provides you with the overall market size and trends, key drivers, opportunities and challenges, key suppliers in the category and how to improve strategic supplier partnerships. 

The pharmaceutical and biotech industries are witnessing rapid growth and innovation, driving the need for efficient research and development (R&D) processes. Contract Research Organisations (CROs) have emerged as key partners providing outsourced services across various domains such as preclinical services, clinical trials management, regulatory affairs, and more.

Contract Research Organisations, are external service providers that offer specialised support to pharmaceutical and biotech companies. They play a critical role in accelerating drug development, reducing costs, and enhancing operational efficiency for their clients.

Breakdown of main services offered by CROs:

1. Preclinical Services Preclinical testing, including in vitro and in vivo studies, to assess the safety and efficacy of drug candidates before human trials.

2. Clinical Trials Management Planning, execution, and oversight of clinical trials, ensuring adherence to protocols, data collection, and regulatory compliance.

3. Clinical Data Management Collection, validation, and analysis of clinical trial data, ensuring accuracy and compliance with regulatory standards.

4. Biostatistics and Statistical Analysis Application of statistical methods to analyze clinical trial data, providing insights on efficacy, safety, and patient outcomes.

5. Regulatory Affairs Expertise in navigating complex regulatory requirements, ensuring compliance with local and international regulations.

6. Pharmacovigilance and Drug Safety Monitoring, evaluation, and reporting of adverse events and side effects associated with investigational drugs and marketed products.

7. Medical Writing Preparation of regulatory documents, study protocols, investigator brochures, and other scientific and medical documents.

Contract Research Organisation Market Trends

The global CRO market has experienced significant growth in recent years, driven by increasing outsourcing trends and the need for specialised expertise. According to industry reports, the CRO market was valued at $41.98 billion in 2023, and it is projected to grow to $57.95 billion by 2028 at a CAGR of 6.66%.

Market size value in 2023

$41.98  Billion (USD)

Revenue forecast 2028

$57.95 Billion (USD)

Growth Rate

6.66.% CAGR from 2023 to 2028

Source:  Market Data Forecast

Market trends and key drivers 

1. Increasing Outsourcing of R&D Activities

Pharma and biotech companies are outsourcing a larger portion of their R&D activities to CROs to leverage their expertise, reduce costs, and accelerate drug development timelines.

2. Growing Focus on Specialised Therapeutic Areas

There is a rising demand for CROs with expertise in specialised therapeutic areas, such as oncology, neurology, rare diseases, and gene therapies.

3. Technological Advancements and Data-Driven Approaches

CROs are adopting advanced technologies, such as artificial intelligence (AI), machine learning (ML), and big data analytics, to enhance efficiency, data quality, and decision-making capabilities.

4. Regulatory Complexities and Compliance Requirements

The pharmaceutical industry is subject to stringent regulatory frameworks, necessitating CROs to maintain expertise in regulatory affairs and ensure compliance throughout the drug development process.

5. Global Expansion and Emerging Markets

CROs are expanding their presence in emerging markets, such as Asia-Pacific and Latin America, to tap into growing opportunities and leverage cost advantages.

SWOT Analysis

The contract research market presents both significant opportunities and challenges for suppliers, as this SWOT analysis shows:

• Expertise in Clinical Research and Development. CROs possess deep domain knowledge and expertise in clinical research, ensuring high-quality execution of R&D projects.
• Access to Specialized Knowledge and Resources. CROs provide access to a wide range of scientific, medical, and technical resources, including specialised investigators, advanced technologies, and global networks.
• Flexibility and Scalability. CROs offer flexible and scalable solutions, allowing pharmaceutical companies to adapt to changing project requirements and resource needs.
• Quality Control Challenges. Ensuring consistent quality across multiple projects and sites can be challenging for CROs due to the complexity of operations and varying standards.
• Pricing Pressure and Margin Erosion. The CRO industry is highly competitive, leading to pricing pressure and potential erosion of profit margins, requiring efficient cost management strategies.
• Talent Acquisition and Retention. Attracting and retaining top talent is a constant challenge for CROs, particularly in specialised therapeutic areas and emerging technologies.

Opportunities

• Rising Demand for Personalized Medicine. The shift towards personalised medicine opens opportunities for CROs to support tailored clinical trials and companion diagnostic development.
• Increased Adoption of Virtual Trials and Decentralised Approaches. The COVID-19 pandemic has accelerated the adoption of virtual trials and decentralised approaches, creating opportunities for CROs to provide innovative solutions and virtual trial management services.
• Expansion into Emerging Markets. Emerging markets offer untapped potential for CROs, as pharmaceutical companies increasingly focus on global expansion and access to diverse patient populations.
• Regulatory Uncertainties. Evolving regulations and regulatory uncertainties pose challenges for CROs in maintaining compliance and adapting to changing requirements.
• Intense Competition and Consolidation. The CRO market is highly competitive, with numerous players vying for market share, leading to potential consolidation and increased competitive pressures.
• Data Security and Privacy Concerns. Handling sensitive patient data and ensuring data security and privacy present ongoing threats for CROs, requiring robust data protection measures.

Key Suppliers

Here is a list of some of the top contract research organizations around the world, in alphabetical order:

• Advanced Clinical
• Charles River Laboratories
• KCR Kiecana Clinical Research
• PPD (Thermo Fisher)
• PRA Health Sciences
• Syneos Health
• Worldwide Clinical Trials
• WuXi AppTec

How to partner better with Contract Research Organisations 

In order to establish better partnerships with PAT suppliers and effectively manage costs without compromising quality, pharmaceutical procurement teams can consider the following strategies:

Clearly Define Project Requirements and Expectations

Clearly communicate project goals, timelines, deliverables, and quality expectations to ensure alignment between the pharmaceutical company and the CRO.

Foster Open Communication Channels

Establish regular communication channels, such as project meetings and status updates, to foster collaboration, address concerns, and ensure transparency.

Establish Performance Metrics and Key Performance Indicators (KPIs):

Define measurable performance metrics and KPIs to monitor the CRO’s performance, track progress, and address any deviations from agreed-upon standards.

Conduct Thorough Cost-Benefit Analyses

Evaluate the value proposition of engaging with a CRO by conducting comprehensive cost-benefit analyses, considering factors such as expertise, quality, timelines, and cost.

Explore Flexible Pricing Models and Contracts

Negotiate flexible pricing models, such as milestone-based payments or risk-sharing arrangements, to align incentives and optimize cost structures.

Streamline Processes and Eliminate Inefficiencies

Collaborate with CROs to identify and streamline inefficient processes, eliminating redundancies, and optimizing resource utilization.

Leverage Technology and Automation

Embrace technological advancements  and automation solutions to improve operational efficiency, data quality, and cost-effectiveness.

Develop Long-Term Partnerships for Cost Optimization

Establish long-term partnerships with preferred CROs to leverage economies of scale, improve cost predictability, and foster continuous process improvement initiatives.

Contract Research Organisations

Antibiotice sa, aragen life sciences, astatech (chengdu) biopharmaceutical corp., biodeal pharmaceuticals., chemelectiva, conscio group, coriolis pharma research, dadachanji group of companies, enzymicals ag, eurofins advinus, global pharma healthcare, gulf biotech, hunan jiudian pharmaceutical, intertek pharmaceutical services, jay chemicals, kaisha lifesciences., laboratorios salvat,, microinnova engineering, nanomol technologies, pharma targeting, pharma-data, more category guides.

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What is a contract research organization plus, top 5 cros to check out in 2022.

What is a CRO?

A contract research organization, or CRO, is a company that provides outsourced research services to pharma companies and similar entities (also known as sponsors), supporting them in all aspects of developing and bringing new drugs/medical devices to market.

Keep reading to learn more about what CROs do, how they are different from clinical research organizations and why sponsors work with them. We’ve also included the top 5 CROs at the end and what you need to ask before signing the contract with a CRO.

What Do CROs Do?

The main role of CROs is to carry out activities that the sponsoring pharmaceutical company cannot or chooses not to do in-house.

Pharmaceutical companies often count on both internal and external resources, but sometimes they need assistance with tasks that fall outside of their core capabilities. The main services that CROs typically provide are running clinical trials and managing data, although they can also help with other tasks like recruiting patients, protocol development, drug manufacturing, and more. CROs might themselves partner with other companies to provide robust services across the full spectrum of clinical trial activities. For example, CROs might partner with Power as a part of a multi-layered recruitment strategy for a trial.

The goal of a CRO is to provide pharmaceutical companies with the services and resources they need in order to get their new drugs approved by regulatory bodies like the FDA.

For example, if a company is working on developing a promising new drug, it may decide to hire a CRO to conduct clinical trials. The CRO would then be responsible for recruiting patients to participate in the trial as well as overseeing the trial itself and reporting the results back to the pharmaceutical company.

See the image below for some example services offered by CROs:

Are Contract Research Organizations the Same as Clinical Research Organizations?

Contract research organizations (CROs) are involved in all aspects of the clinical development process, from initial drug discovery through pre-clinical and clinical trials and regulatory approval.

They also often offer post-marketing support services such as phase-IV studies and safety surveillance. CROs may also help design a study, recruit patients for the study, perform laboratory tests on samples taken from patients in the study, monitor patient health during the study, analyze study data, prepare study reports, and present reports or summaries to the relevant regulatory bodies like the FDA.

A clinical research organization , on the other hand, is a specific type of CRO that specializes in conducting clinical trials for pharmaceutical companies and other organizations.

While some clinical research organizations do offer preclinical services, most focus primarily on phase-I through phase-IV studies for new drugs and medical devices. These trials are designed to test the safety and effectiveness of drugs, devices, or medical procedures in humans. The purpose of a clinical trial is to gather data that can be used to determine whether a drug or device should be approved for human use by the FDA.

Although clinical and contract research organizations may differ in some ways, they can both be contracted to conduct clinical trials.

Both types of organizations need to be certified by the FDA in the USA (or by the relevant regulatory agency in other countries). However, the certification process differs depending on the type of organization. For example, a clinical research organization must go through an extensive accreditation process before it can begin conducting clinical trials on humans. CROs may not necessarily need to pass this accreditation process if they are not involved in conducting clinical trials involving humans.

Why do sponsors work with CROs?

CROs play an important role in pharmaceutical and biotechnology product development. Here are just some of the reasons why sponsors (pharma, biotech and similar entities) may decide to work with CROs.

1. Specialized operations and cost control

Building and managing clinical trial operations completely in house is complicated, expensive and requires specialization in a multitude of areas. The entrance of CROs meant that pharmaceutical companies no longer needed to own all of their own scientific and clinical research facilities. Full-service CROs offer sponsors a complete set of solutions covering all requirements from before clinical trials even start, to launching the final drug or device on the market.

2. Improved access to technology

CROs offer various technology solutions to support sponsors in designing, conducting and managing clinical trials. Sponsors can choose to leverage these technologies depending on the needs of each unique study. Here are some example categories of technologies that sponsors may use: planning tools (protocol design, patient enrollment etc.), site management (activation, payments etc.), recruitment tools (e.g., Power ), trial management tools, clinical data analytics etc.

3. Ability to handle large amounts of data

There are a lot of moving pieces involved in successfully running a clinical trial. CROs are often used by pharmaceutical companies because of their ability to handle large amounts of data in a short amount of time.

4. Handling regulatory affairs (i.e., following FDA guidelines)

CROs typically have experience working with regulatory agencies such as the Food and Drug Administration (FDA). The FDA regulates the entirety of clinical drug trials, from design to implementation and final analysis. This means that CROs must work within the FDA’s guidelines when conducting any type of clinical trial. It also means that CROs can help pharmaceutical companies get their products to the market faster, as they do not need to hire internal experts specializing in these stringent and ever-changing regulations.

5. Multi-disciplinary expertise leading to quicker and more effective trials

CROs have access to a large pool of employees specialized in different areas, which means that they can provide pharmaceutical companies with the appropriate expertise needed to complete any type of clinical trial quickly and effectively.

Another benefit of contracting an outside supplier for research is that the contracting company does not have to hire someone internally who is up-to-date on all the latest trends and regulations regarding the product development process (thereby avoiding potentially long delays for training). Independent third-party contractors are often more experienced than in-house employees in terms of familiarity with clinical trials and regulatory compliance.

What Are The Top CROs in 2022?

The contract research organization (CRO) industry is rapidly growing, and it's easy to see why due to the roles they fulfill in pharmaceutical and biomedical research. As of 2022, there are over 2,700 CROs in the US and that number is growing.

The following list identifies some of the top contract research organizations (CROs) in 2022:

IQVIA is a healthcare technology company providing integrated services in clinical research, market access, and health outcomes. It works with pharmaceutical companies to develop new medicines and therapies for the treatment of diseases including cancer, diabetes, heart disease, hepatitis C, and HIV/AIDS.

IQVIA provides clinical trial support services through its subsidiary Quintiles Transnational Holdings Inc., which was formed in 2017 when Quintiles Transnational merged with IMS Health Holdings Incorporated.

2. Labcorp Drug Development

Labcorp Drug Development, formerly Covance, is a contract research organization that offers drug development, clinical trial, and laboratory services to the pharmaceutical industry. The company's mission is to help advance patient care by providing clients with high-quality services and solutions.

Labcorp was founded in 1996 and has since grown into one of the world's largest CROs, with over 40 offices worldwide. In addition to its global presence, Labcorp also maintains a strong presence in the USA, which is one of the largest national markets in the pharmaceutical industry.

3. Pharmaceutical Product Development (PPD)

Pharmaceutical Product Development, or PPD for short, is an international company known for developing drug delivery systems and pharmaceuticals to help patients around the world.

The company has been working in the pharmaceutical industry since 1985 and operates in numerous countries. Their headquarters are located in North Carolina, U.S.A., but they also have offices in Europe, Asia, Africa, and South America.

ICON offers a full range of consulting, clinical development and commercialisation services to pharma, biotech, medical device and government organizations. ICON has a global team of experts and extensive experience in a wide range of therapeutic areas.

ICON was founded in Dublin, Ireland in 1990 and has offices in 46 countries worldwide.

Medpace provides full-service clinical development services to biopharma and medical device sponsors. Founded in 1992, they have always held to a model of providing full-service clinical trial outsourcing. Medpace operates in 6 continents and has medical, operational, and regulatory specialists with country-specific expertise.

CROs in the Healthcare Industry - What You Need to Ask Before Signing the Contract

1. Get information from multiple sources. It's important to gather as much information as possible before making any decisions. The website of the CRO itself will not tell the whole story; it is a good idea to look for real reviews and feedback from other companies who have contracted the CRO to which you are considering outsourcing tasks.

2. Make sure that the CRO you are considering has an established track record of success with clients.

3. Check that the CRO has an active online presence and transparent contact information so you can contact them and research them further before signing anything.

4. Check that the company is up-to-date with regulatory standards and accreditations. These are renewed frequently as this is a rapidly changing industry, so verify that the CRO in question has up-to-date authorization and accreditation for the specific tasks you are considering contracting them for. If you can’t find this information on the website, contact them to get clear answers.

5. Make sure that the CRO has a good reputation among other firms in the industry as well as among current and past employees. A large number of sub-par reviews or complaints is a red flag, as are complaints by employees about protocols not being followed, internal uncleanliness or disorganization, etc.

6. Verify that the CRO has expertise in the specific task you wish to outsource! This may seem obvious, but just because a given CRO is world-renowned in conducting clinical trials, this does not mean they will be experts in analyzing your specific data. You should contract a contract research organization specializing in the tasks you will give them.

CROs play important roles in pharmaceutical and biotechnology product development. They essentially manage every aspect of the clinical research process while also providing access to state-of-the-art technology and facilities, thus also keeping costs down for the sponsor. If you are looking for a CRO to partner with to streamline or enhance your research, development, or clinical trial processes, a little bit of research to understand what they are capable of and what tasks they are specialized in will help you make an informed decision.

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Popular guides.

What is a contract research organization (CRO)?

Clinical trial services.

What does a CRO do?

CROs are hired by sponsors who want to run a clinical trial. This eliminates the need to hire full time staff to complete the project and provides an opportunity to work with the CRO on a project-by-project basis. The CRO is hired to plan, coordinate, execute, and manage the lifecycle of the clinical trial, safely and efficiently. Serving as the main contact between the sponsor and other stakeholders throughout the trial, the CRO communicates with ethics and compliance committees, regulatory personnel, vendors, physicians, and research coordinators.

What does a CRO mean in clinical trials?

CROs have the knowledge, capabilities, processes and procedures that are needed to develop and run a successful clinical trial, while ensuring trial quality and compliance with national and international standards. Working with a contract research organization can offer innovative tools that can increase efficiencies, leading to decreased timelines and cost. Choosing the right CRO to run your clinical trial is crucial to the trial success. In addition to consideration of their own project needs, requirements, and budget when selecting a CRO, Sponsors should evaluate the qualification, experience, and quality system processes of the CRO.

Our CRO services

MED Institute is a full service contract research organization with over 35 years of experience designing and executing clinical trials, ranging from early feasibility studies  to multinational, controlled pivotal trials to post-market registries. Our clinical trial services include clinical trial planning, clinical data management, clinical project management, and clinical trial monitoring.  Our MED team is able to support your clinical study from start to finish or is able to help with one specific aspect of the clinical study (e.g., monitoring).

Clinical trial planning and study start-up include the process of creating the clinical plan and clinical protocol and obtaining the necessary approvals from regulatory authorities and ethics committees. We can help you design a clinical study tailored to your product’s specific needs, to collect data efficiently while meeting all regulatory requirements. Our protocol development process involves working in collaboration with clinical experts and other study stakeholders to identify reasonable performance goals, to determine appropriate examinations and procedures, and to define the right patient population. It ensures the clinical study protocol will successfully implement the study plan and maintain compliance with all applicable regulatory requirements. A well-written protocol is essential to maximizing efficiency and minimizing risks in gathering the necessary clinical data for your product.

Clinical data management is critical to the clinical trial process. We are dedicated to providing high quality clinical data management services to support your product development needs, obtaining clinical trial data you can trust to save time and resources. We can create case report forms (CRFs) that ask the right questions to achieve your clinical trial’s goals in a simple and intuitive way. These CRFs are customized to suit the project type and individual requirements for streamlined data entry, avoiding the unnecessary delays and potentially inaccurate data that often result from poorly designed CRFs.  We can generate paper or electronic CRFs based on the clinical trial and Sponsor requirements.

Drawing from our experiences working with hundreds of investigators worldwide, we are able to build efficient, intuitive electronic data capture (EDC) systems that are simple for investigators to learn and use. The benefits of a well-designed, well-built EDC system contribute to minimizing the time and cost to run a clinical trial. Learn more about designing and building an EDC system in our “Considerations for designing and building an electronic data capture (EDC) system” blog series-  Part 1: with users in mind  and  Part 2: with sponsors/CRO in mind .

Clinical project management is important to ensure that your trial runs as smoothly as possible. Our clinical project management team has decades of experience managing trials ranging from first-in-human proof of concept to multinational, multicenter, controlled pivotal trials. We emphasize efficiency in conducting clinical trials, while maintaining exemplary quality and compliance. Our team can complete clinical site assessments, help you prepare documentation for IRB/Ethics Committees, complete the site initiation and training, and complete the necessary steps for trial closeout. Our experience with a multitude of trial sites around the world has taught us how to evaluate potential sites, and the right questions to ask to determine the best fit for each clinical trial. We also strive to see that candidate sites learn enough about the requirements of the clinical trial to determine whether it is a good fit for them. Smart site selection contributes greatly to completing a clinical trial on time and on budget.

Clinical trial monitoring helps ensure that the trial is conducted, recorded, and reported in accordance to the protocol, ethics committees, and Good Clinical Practice (GCP) . We create comprehensive, but efficient, monitoring plans to manage clinical trials and engender confidence in clinical trial integrity. Analytics are used to implement a risk-based approach to monitoring, which reduces costs without sacrificing assurance of data reliability, investigator compliance, or meeting regulatory reporting obligations. Active clinical monitoring can help predict potential clinical trial challenges or at least identify issues early so they may be addressed before they lead to significant delays leading to increased costs, or derail the trial completely.

How to choose a good contract research organization

Choosing a good CRO is very important and contributes to the success of the study and helps the trial to run as smoothly as possible. Some of the questions to ask when choosing a CRO are:

• Do they have an established quality system, with procedures to address the assigned clinical study activities?
• Are they responsive and willing to work with you and communicate throughout the project?
• Do they have stable project teams is there high turnover?
• Can they assist with data management?
• Will they help you recruit and manage safety boards or committees?
• Will they be able to conduct audits to help you prepare to pass BIMO FDA inspections ?
• Can they provide general site support and project management help in addition to clinical monitoring?

CROs are hired by Sponsors who want to run a clinical trial and become a fundamental part of the trial. They offer a wide variety of services associated with conducting the study from start to finish. It is important to choose a good CRO as the success of your trial is dependent on the management and capabilities of the CRO.

We can partner with you to successfully take your clinical trial from start-up to trial close out. Contact us today to discuss your clinical trial needs 855.463.1633 | [email protected] | medinstitute.com.

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The CRO Industry in Flux: Navigating Technology, Business Models, and Trends in Pharma R&D Outsourcing

As the global pharmaceutical landscape continues to transform at a breathtaking pace, it becomes crucial to examine the phenomenon that is powering this change - Contract Research Organizations (CROs). With the burgeoning demands of the pharma R&D sector, we're seeing an uptick in the trend of outsourcing, and central to this discourse is understanding what a CRO is. At the core, these entities offer outsourced research services to their clients in the pharmaceutical, biotechnological, and medical sectors. This article aims to provide a comprehensive exploration into the intricate world of CROs, their burgeoning role, and the potential impacts they have on the evolving pharma R&D outsourcing industry. We delve into the various aspects of their operations, dissect the driving factors behind their growth, and evaluate the potential challenges they face in the current pharmaceutical environment.

Pharmaceutical companies are increasingly outsourcing their R&D activities , including early-stage research programs, to third party organizations -- academic institutions, biotech startups, and private CROs -- as a means to stay competitive, flexible, and profitable against all odds.   

Economically, there are factors such as increasing downward pressure on drug pricing by governments, an impending “patent cliff” threatening $198 billion worth of sales during 2019-2024 ), and downturns in income due to the increasing competition from generics and biosimilars. 

From the innovation's point of view, there is a boom in life sciences, stimulating the emergence of novel biological targets, therapeutic modalities, and even whole new areas of drug discovery -- adding opportunities, but also complexity and uncertainty to research programs. In fact, according to Deloitte’s report , return on late-stage pipelines dropped for the top 12 pharma companies from 10.1% in 2010 down to 3.7% in 2016.

Technologically, there is an unfolding “digital revolution”, bringing even further complexity and investment cost to the table -- in a form of artificial intelligence (AI), data mining and big data technologies, data-driven diagnostics, and digital health. 

Finally, the rise of the personalized medicine paradigm forces companies to rethink their research pipelines and “one-size-fits-all” product development programs, as well as reconsider their market strategies. 

The interplay of the above circumstances appears to be a favorable situation for the contract research market, leading to steady growth in this sub-sector. According to a report by Clearwater International (autumn 2019), the global CRO industry exhibits market growth of around 10% CAGR with projected acceleration up to 12% through to 2022, potentially reaching $45B market value. 

Another natural factor of growth for the CRO industry is the overall increase in the number of biotech companies and the volume of ongoing research projects in the pharma industry -- since 2007 the number of drug candidates under development almost doubled (15267 in 2018 vs 7737 in 2007). 

Pharmaceutical CRO industry at a glance 

The roots of the contract research business can be traced back to the mid-1900s when companies like Huntingdon Life Sciences and Charles River Laboratories emerged to offer basic animal experimentation services. The pharmaceutical CRO industry as we know it only started to shape in 1970-80s -- with the emergence of a regulatory frameworks for the pharmaceutical market, expansion of then-existing contract research companies into clinical trials and other functions, and foundation of new companies -- future CRO industry giants, like Quintiles (1982), Parexel (1982), and PPD (1985). 

Today, the CRO industry is fairly fragmented including more than 1000 organizations, although relatively few of them are global full-service companies. However, it is those few largest CRO industry players, like Covance, IQVIA, Syneos Health, Parexel, PPD, PRA Health Sciences, Charles River Labs, Wuxi Apptec, and Medpace, who control the lion’s share of the market. According to a study by the Tufts University Center for the Study of Drug Development (CSDD) , the top 10 largest CROs benefited from around 57% of outsourcing spend in 2018, which is 12% more than in 2011. 

Estimations by Objective Capital Partners suggest that the global contract research market in 2019 is valued at around $30B and growing. According to a 2016 report by Credit Suisse, the CRO industry can be roughly segmented into the four market categories with each having the following shares of the pie: central lab services -- 4%; preclinical services -- 9%; clinical stage services -- 42%; and post-approval activities -- 45%.   

According to David Widley, equity analyst at Jefferies consulting firm, currently, big pharma outsources around 40-45% of their activities to CRO industry players, and he expects this number grows up to 60% in the future. In contrast, small and medium-sized companies outsource substantially more of their activities -- up to 65-70% and the emerging biotech startups typically outsource up to 90%, some of them operating as “virtual” companies. 

Evolving business models of CRO industry players 

When outsourcing R&D services, a straightforward Fee-For-Service task-based model is utilized for separate well-defined services, like screening a library of compounds against a known target or synthesizing a reference compound, which can be performed for a pre-agreed price. 

Another option -- the Full-Time Equivalent (FTE) model, where a sponsor company, basically hires a science project team at CRO premises and pays for all the materials and other project expenses. The FTE model is suitable for multifaceted more complex projects, where flexible continuous discovery work is anticipated, as this model allows to minimize contractual bureaucracy. 

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Austin Ulrich

What is a Contract Research Organization (CRO)?

In a world where medical breakthroughs are becoming increasingly complex, Contract Research Organizations (CROs) are an invaluable resource for pharmaceutical and biotechnology companies. They provide services such as data management, clinical project management, biostatistics, medical writing , and regulatory compliance that enable businesses to develop more effective treatments faster and more efficiently.

By partnering with a CRO, companies can reduce costs while gaining access to specialized expertise—bringing life-saving treatments to the market in record time.

CROs are one of the most important and valuable assets when it comes to medical research organizations. They can provide clinical trial guidance and support for pharmaceutical, and biotechnology companies, and provide helpful resources and knowledge that can be key for your project to run smoothly.

Working with a CRO, businesses can save time and resources while also gaining access to valuable knowledge and technology. Working with the right CRO is key to ensuring success in drug development projects; by selecting a CRO that meets their needs.

Investing in the services of a CRO can be incredibly beneficial for your organization as they specialize in overseeing large portions of clinical trials on behalf of their clients. Read further to learn all about what makes up this type of medical research organization.

Definition of Contract Research Organizations/Clinical Research Organizations

Contract Research Organizations (CROs) and Clinical Research Organizations (CROs) are companies hired by pharmaceutical and biotech corporations or research centers to take over certain parts of running a clinical study and play a crucial role in the world of medical research and clinical trials.

These organizations help manage complex projects that involve testing new drugs, treatments, and medical devices. CROs provide a range of services, from project planning to data collection and analysis, and work alongside pharmaceutical and biotech companies to ensure that clinical trials are conducted safely, efficiently, and in compliance with regulations.

Through their expertise in project management, CROs help to accelerate the development of new treatments and bring them to market faster, ultimately benefiting patients in need.

Purpose and Role of CROs in the Pharmaceutical and Biotechnology Industries

CROs provide essential services to pharmaceutical and biotechnology companies in order to advance their research and drug development efforts.

Pharmaceutical and biotechnology industries rely heavily on clinical development and trials to ensure the safety and effectiveness of their products.

The clinical trial process, however, is not an easy feat. It requires precision, accuracy, and keen attention to detail. This is where contract research organizations come in.

CROs are important in helping these companies conduct clinical trials smoothly and efficiently. They assist in various aspects of the clinical trial process, including clinical monitoring, data management, and regulatory compliance. In doing so, they provide support in running successful clinical studies, accelerating the development of new drugs, and advancing medical research.

History and Evolution of CROs

The emergence of CROs has revolutionized the pharmaceutical and biotechnology industries, providing essential services to support companies in their development of more effective treatments.

In the ever-evolving world of drug development, Contract Research Organizations play an integral role in bringing new therapies to market. But how did CROs come to be?

Their history and evolution can be traced back to the early days of clinical trials, where pharmaceutical companies were responsible for conducting their own research. However, as the drug approval process became more complex and global regulations increased, the need for specialized services grew.

Today, CROs offer a range of expertise and support, from preclinical research to post-marketing studies. By partnering with CROs, pharmaceutical companies can accelerate the drug development timeline, while retaining the highest level of quality and compliance.

Current trends and future prospects

One of the current trends in CROs is the increased focus on global coverage and regulatory compliance. As regulations governing drug development become increasingly complex and varied across different markets, companies must ensure that their research processes meet these high standards.

CROs specialize in providing expertise and support to companies with regard to regulatory compliance, helping them stay ahead of the curve.

The future prospects of Contract Research Organizations (CROs) look incredibly promising. CROs are playing an increasingly important role in the development and production of new drugs and medical treatments. As the pharmaceutical industry continues to grow, so too will the demand for CRO services.

The prevalence of CROs in the pharmaceutical industry is on the rise. As drug development continues to evolve and companies strive for faster, more efficient, and cost-effective methods of research, CROs are becoming an invaluable asset to healthcare providers and researchers alike. In the near future, CROs are expected to continue to provide valuable services.

Services Offered by CROs

CROs, play a pivotal role in the development of new drugs and medical interventions. These organizations offer a wide range of services to pharmaceutical companies and other stakeholders in the healthcare industry. They can help with everything from the development of study protocols to the collection of data and publication. They also assist with statistical analysis and the management of regulatory issues.

By outsourcing these tasks to a CRO, companies can streamline their research efforts and focus their resources on core competencies. With the help of CROs, it’s possible to bring life-changing treatments to market faster and more efficiently than ever before.

Preclinical research

CROs provide a range of services related to preclinical research, including the design of study protocols, regulatory support and consulting, data management and biostatistics, medical writing, and publication support.

Preclinical studies involve the testing of drugs to determine safety and efficacy before progressing to clinical testing. The role of CROs in this is to evaluate and test a drug at the drug discovery stage. You can benefit from their knowledge and expertise in the testing stage before submission to the regulatory authorities.

Clinical trials

Clinical trials are studies of drugs or treatments that involve human participants. They are conducted to evaluate the safety and effectiveness of a drug or treatment in order to determine whether it should be approved by regulatory agencies for use in humans.

Clinical trials typically involve administering the drug or treatment to healthy volunteers or patients with a certain condition and then observing its effects.

CROs play a vital role in running a successful clinical trial. Working with a CRO can help ensure that these clinical trials are conducted according to the highest ethical standards and regulatory requirements, while also providing valuable data for decision-making.

Regulatory support and consulting

CROs provide essential support to pharmaceutical companies and other stakeholders in the healthcare industry when it comes to regulatory compliance and consulting services by providing guidance on how to develop protocols and processes that meet standards.

They also provide critical advice to facilitate product development. They are knowledgeable about the regulations and standards in place for drug development, and they use this expertise to assist companies with navigating the complex and ever-changing landscape of regulatory requirements.

Data management and biostatistics

CROs are experts in collecting, organizing, analyzing, and managing large amounts of data. Data management is a crucial element of any clinical trial, as it ensures that the data collected is valid and accurate data.

They provide specialized expertise and technology to help researchers design studies, analyze data, and develop models to explain observed phenomena and draw meaningful conclusions.

The use of CROs helps researchers better understand complex medical data and make evidence-based decisions

Furthermore, they use sophisticated statistical models to analyze complex medical information objectively. All of these services help pharmaceutical companies develop treatments more quickly and bring them to market faster. Ultimately, partnering with a CRO is essential for ensuring that the development process proceeds efficiently and effectively.

Medical writing and publication support

CROs play an important role in the publication of clinical trial research. In-house experts and medical writing teams at CROs are responsible for preparing documents that effectively and accurately summarize clinical trial results for submission to regulatory authorities and journals.

Alternatively, using automated tools like artificial intelligence (AI) for medical writing is another way to speed up the content creation process. In fact, using AI is one of the ways companies in the medical field can boost productivity .

By working with a CRO, companies can ensure that their clinical trial results are properly represented and presented in a clear, concise manner. These documents must be written in accordance with applicable standards, guidelines, and regulations to ensure accuracy and compliance.

Selecting the Right CRO for Your Project

Choosing the right CRO is crucial for the success of your project. The right CRO can cut down costs and ensure that your project runs smoothly, while the wrong one can cause costly delays and setbacks.

To select the right CRO, you need to consider various factors such as expertise, experience, cost, and communication skills. Look for an organization that has a good track record in your specific field of research, and that can provide you with a tailored approach that meets the needs of your project.

Additionally, if you are looking to work with a CRO that is located in a different country, you should pay attention to their language and cultural barriers, and ensure that your communication channels are effective.

By choosing the right CRO, you can increase your chances of success and ultimately bring your project to fruition.

Benefits of Working with a CRO

Access to specialized expertise and technology.

CROs have access to specialized expertise and technology that enable them to provide comprehensive services to companies. CROs are knowledgeable about the regulatory environment, can assist with data management and biostatistics needs, provide valuable support, and help ensure compliance with applicable standards.

Reduced costs and resources needed for research

When partnering with a CRO, companies gain access to specialist knowledge in order to reduce costs while speeding up development timelines. Ultimately this helps bring treatments to market faster and more efficiently as they already have the necessary resources in place to ensure a sped-up process.

Increased accuracy, validity, and objectivity in data collection and analysis

CROs have access to specialized technology and expertise that enable them to ensure quality control throughout the research process. This allows clinical trial results to be accurate, valid, and objective. They provide specialized experience which enables them to design studies that are comprehensive and compliant with applicable regulations. They also employ rigorous protocols to ensure the accuracy of data collected during clinical trials.

Challenges and Potential Drawbacks of Working with a CRO

Cros are often expensive to work with.

Although CROs can provide vast amounts of expertise, resources, and technology, this comes at a cost. Companies may have to pay for all services rendered upfront, making it difficult to budget for large-scale projects. It is important to take the time to understand the costs associated with working with a CRO and compare those against the benefits of outsourcing certain tasks.

Potential loss of control within the project

When partnering with a CRO there is a risk that it could lead to a loss of control over certain aspects of the project It is important for companies to ensure clear communication channels are established so that expectations are managed and all stakeholders remain informed.

Working with a contract research organization (CRO) can provide numerous benefits for businesses in need of research services. By outsourcing research tasks to a CRO, businesses can save time, money, and resources while also gaining access to specialized expertise and technology.

CROs can help design and execute studies, collect and analyze data, and provide valuable insights and recommendations. Additionally, working with a CRO can help businesses maintain objectivity and impartiality in their research while avoiding conflicts of interest.

These research organizations provide specialized expertise that enables them to design studies that comply with regulations, manage data, analyze complex medical information objectively, prepare documents for publication, and ensure compliance with applicable standards.

By working with a CRO, companies can reduce costs while speeding up development timelines which ultimately helps bring treatments to market faster and more efficiently. However, it is important for companies to establish clear communication channels so expectations remain managed throughout the project lifecycle.

Overall, partnering with a CRO is a smart choice for businesses looking to optimize their research efforts and maximize their return on investment.

Austin is a blogger, entrepreneur, and freelance medical writer. He spent 8 years in the pharmacy profession prior to going full-time with his business, Ulrich Medical Writing, LLC. As a blogger, he's passionate about helping others create freedom and time in their lives by earning and keeping more income. He enjoys running, music, and traveling with his wife and 4 kids.

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What is the Business Model of a Contract Research Organization?

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Taking a drug through the regulatory pathway can be challenging, time-consuming, and very costly. Owing to that, biotech and pharmacy companies prefer to outsource that work to contract research organizations. Note that a contract research organization, most often referred to as a clinical research organization or CRO, is a company that helps conduct research for a sponsor company. This research can include anything from pre-clinical development of new products to post-marketing research activities.

According to reports, CROs have been around for decades — they first appeared in the 1940s and 1950s with the likes of Huntingdon Life Sciences and Charles River Laboratories. Although CROs are the outsourcing partner for the life sciences sector, some other industries are gradually beginning to leverage this concept.

For instance, Tech companies have started outsourcing certain key proponents of their business. Some time ago, Skype made use of outsourcing services to establish the back-end development of its app, and Google still very much works with companies like Cognizant.

Note that the primary reason why a sponsor company utilizes the services of a contract research organization is that contract research organizations are experts in conducting research. Contract research organizations help pharmaceutical or biotechnology companies by helping them save costs and also lessen the time needed to conduct clinical trials.

Businesses may also outsource clinical trials once they feel they lack the complete know-how of regulatory affairs in a specific area of interest or if regulations mandate them to have a legal presence in that country before carrying out clinical trials.

Don’t forget that a contract research organization (CRO) can work with several sponsors. As experts, CROs are a valuable resource for pharmaceutical companies. They are fast to adopt the latest technologies, allowing them to offer unique insights and advice, spotting novel and exemplary ways of utilizing these advanced tools, and adapting them to each sponsor’s needs to ensure optimal clinical trial performance.

4 Business Models for Contract Research Organizations

Contract research organizations are mostly B2B establishments and everyone benefits from their efforts. While a good number of them stick to the variable pricing model, some adjustments are becoming prevalent in the industry. Here are a few business models being adopted by industry players in recent times.

1. Fixed Price Models

This business model, according to experts, remains very advantageous to projects with a detailed scope and a pronounced set of requirements. This sort of business model tends to put all of the risks associated with the project on the CRO because the sponsor won’t pay until the work is completed. Note that this model is more suitable for long-term projects with a high value to the sponsor because it makes the CRO complete the work efficiently.

Time and Materials (T&M)

One of the most popular business models in the world, the T&M requires contract research companies to bid for the project based on the sponsor’s requirements, depth of scope, and the amount of work that will be completed. Have it in mind that this model works really well if the teams involved are experts at noting the project needs. That way, the CRO will invest less time reworking problems, shortening the project completion time and saving the sponsor money.

Incentive-Based Pricing Models

Well renowned as an add-on to the more traditional models noted above, incentive-based models feature bonus payments to the CRO as a reward for meeting performance goals above and beyond what’s noted in the contract agreement. Have it in mind that these incentives can make up for shortcomings in fixed-price or T&M models ensuring your CRO’s motivations stay in line with the sponsor’s own.

Shared Risk-Reward Pricing Model

Note that this business and pricing model comes with enough flexibility that it is becoming hard to ignore amongst CROs. Like the Incentive-based model, this model features a flat rate and holds extra payments until the CRO achieves specific objectives. However, in this model, both the contract research company and the sponsor usually share funding for the development of new products, allowing the CRO to also share in the rewards for a specified period.

How Do Contract Research Organizations Make Money?

Note that the ways CROs make money vary based on their business model, type of client, job description, and contract signed. However, they generate revenue from each paying client. The needs of one customer will surely be different from another customer.

The revenue CROs generate also tends to be defined by their short and long-term goals, the size of the company, and their budget. However, the advantage CROs have is that they are directly benefiting regardless of the model or contract.

They are also directly benefiting from that long lead time. They also basically make money on a product regardless of what the outcome is. If a product fails to live up to its expectations, the CRO still gets paid for carrying out a trial.

In addition, if, for instance, a drug enters phase 1 clinical trial, by the time it gets through phase 3, that process can take many years. A CRO that started from phase 1 will likely have to see it through to phase 3. If a CRO lands a good deal early in its life cycle, they get a lot of revenue visibility as the drug develops, and that can be quite attractive.

Contract research organizations are known to partner with biotech and pharmacy companies, and they handle every aspect of the clinical trial process. Note that they can design the trial, get in contact with clinics to carry out the trial, run the tests, analyze the data, and aid with the regulatory submission.

Have it in mind that if a company intends to outsource that work, or even just partner to get consulting advice, CROs are a natural go-to partner for them. However, clearly understanding their expectations and choosing the right pricing model can go a long way to achieving success.

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Top five considerations when selecting a contract research organisation

by Kevin Coker

17 December 2021

Kevin Coker, co-founder and CEO of Proxima Clinical Research provides insight on what is needed to take your medtech, biotech or pharma product from concept to market, quickly. 

You’ve just discovered the next generation of technology to diagnose health conditions, provide better patient outcomes, or even save lives. But it’s a long way from where you are today to commercialising your product. Your near future includes finding investors, creating a sales deck and a regulatory pitch, collecting testimonials, achieving milestones, obtaining regulatory approval, refining your stories, building collateral material, conducting clinical trials, and the myriad of details along your journey to bring your innovative idea from concept to market and beyond; and it’s daunting. That’s where CROs come in.

What is a CRO?

A contract research organisation, or CRO, guides the birth of new medical product ideas and their subsequent emerging companies through the regulatory and clinical pathways to market. 

A CRO can benefit your organisation with a breadth of experience under one roof. A CRO should not only bring you experience, but also efficiency in working with the myriad of experts needed to get from concept to market. Go out and hire ten consultants to work with your company versus one or two service providers and you’ll see what I mean. Expertise that is usually found only in large companies with deep talent benches should be available to all companies, regardless of size, such as the expertise required in:

• Understanding which approval to seek for the quickest, most efficient way to market
• Communicating with regulatory agencies like the USA Food & Drug Administration and other regulatory agencies around the world
• Reaching, tracking, and analysing milestones
• Achieving regulatory requirements
• Setting up and managing clinical trials 
• Recruiting an effective board of directors
• Accessing contract resource expertise, resources, and tools to get to market quickly
• Gaining insight and expertise into the hidden aspects of the clinical trial and approval process.

Contract research organisations can play a significant role in just about every phase of the process when bringing a drug or device to market. That’s why  more and more innovators in pharma and biotech are hiring a CRO  to successfully navigate the process.

CROs can help innovators reduce delays in product launches, which is key for gaining an edge over competitors. And despite the upfront cost, CROs can ultimately help companies save money by streamlining processes, reducing repetition, and providing insight and expertise into the myriad of ways to limit costs and avoid expensive mistakes.

Finding the right CRO for your needs is a key element of your journey to success. Consider these five questions while selecting the right CRO for your needs. 

Beyond the obvious: Five questions to ask while selecting a CRO

Experience in the areas of your specific needs is a given. Consider these additional five questions when selecting which CRO will serve you best.

What size companies does the CRO tend work with most often?

Many contract research organisations work almost exclusively with large pharmaceutical companies. What this says about their approach:

• Their culture is likely to be more formal, corporate, and process-oriented, focussing less on individual innovators and their unique needs, and more on rote systems and processes. Nothing wrong with that. But if you are a three- to five-person team and get overwhelmed on calls with a lot of people on them, you should consider the fitment.
• They are used to working with larger contracts, larger budgets, extended timelines, and can rely on brand name recognition. Their experience can sometimes be misleading, too.  Having experience with multiple product approvals can be great, but don’t put too much comfort on the numbers they put in the marketing materials. CROs are usually a product of mergers, and they pool these numbers. Also, attrition can be an issue, as the people that worked on those projects may have moved on. Institutional knowledge is tough to retain.
• They are traditionally less likely to have the ability to flex or tailor their services per the needs of the client. 
• They are less likely to operate with agility to meet the quick, ever-changing needs that smaller, emerging companies require to meet their milestones and regulatory requirements get to market quickly and cost efficiently.

On the contrary, CROs that focus their solutions on start-up organisations, emerging companies, and smaller or solo innovators are more likely to meet the flexible needs and lower resources of the smaller guy. They are built with agility and focus their work on creating personal relationships, customised partnerships, and hand-holding collaborations to guide innovators through the journey to market. 

Is the CRO a good cultural fit for my needs?

Having a deep understanding and conveying the need, the market, and the solution for your product is a vital part of the role of the CRO. Find out if they have:

• Experience working with clients similar to you and your needs? 
• Overcome challenges and hurdles in your target market in the past? 
• A proven track record launching new drugs and devices? 
• Overused descriptive words such as “deep learning” or unparalleled processes.” 
• If they use these terms, ask what that is about. If they say the marketing team wrote it, ask what’s behind it. 
• Get curious and clarify rather than assume. 

Can they handle your full scope of regulatory and clinical services?

Some contract research organisations focus only on specific phases of regulatory and clinical processes. For example, they may be able to help you set-up and manage your clinical trials, but they won’t necessarily be able to source or help you in fundraising. Or they may be able to provide insight on how to gain market access, but they don’t have extensive experience communicating with the FDA or understanding which approval to seek for the quickest route to market.

To take your drug or device to market as quickly and efficiently as possible, you want a CRO that offers comprehensive services to guide every phase of your regulatory and clinical journey, including:

• Early-stage consulting. A CRO should be able to guide you through each phase of the process, with intent to avoid costly delays, misaligned approvals, and mistakes down the road. 
• Regulatory consulting and communicating with the FDA. A CRO should be able to guide you through every phase of the regulatory consulting process, including preparation for success at each meeting and liaising with the regulatory agencies such as the FDA.
• Reimbursement and market access. A contract research organisation should be able to consult on reimbursement and market access, to ensure that all potential patients who could benefit from your innovation can gain access to your product at the right price.
• Access to funding. If your product stalls out due to funding, you could lose valuable time to market which could cost the entirety of your company, not just market share. Access to the right funding in the right phases can make or break your success.

The bottom line? You want a CRO partner who can guide you through every phase of the journey and deliver specialised expertise, case management, and industry insight along the way.

How will working with the CRO accelerate my progress?

You should expect progress with each meeting, week by week. The CRO should be advancing momentum with your project, and you should always know where you are, why you’re at that stage, and the pieces needed next to advance further.

Take a close look at the CRO’s track record. Asking carefully detailed questions can give you critical insight into whether this CRO will save you time and money in the long run.

Ideally, CRO services should make you money. It’s more than the avoidance of headaches, confusion, delays, do-overs, and reduced costs. It’s their expertise in reducing liability; in making the process run more smoothly; in positioning your product and your company for success from the get-go rather than stumbling clumsily and expensively along. 

The contract research organisation should guide your regulatory meeting preparations, presentations, and supporting documents so that you hit a homerun in each meeting and understand the adjustments and requirements to continue forward to market. This takes a comprehensive understanding of what the regulatory team says it’s looking for and knowing the traps emerging companies often fall into that drains their finances, hopes, and motivation to keep going. Writing for a regulatory body is a very different pitch than persuading a thesis advisor, department chair, or investors. Many times, an entire rewrite is performed before the regulatory process begins. This may take 20-40 hours or more with guided expertise; imagine how long it could take without it. 

How much experience does the CRO have in communicating with regulatory agencies?

Be careful not to overvalue an individual’s or organisation’s consulting experience. What I mean by that is, often groups will tout their “relationship” with the FDA or have consultants that have worked at the FDA in the past. I’ve come across many people in the field that trade on their “time spent at the FDA,” yet they never worked on more than a couple of projects. Or they name drop people they know or are friends with. This might be more of a red flag than a differentiator.

Many people exaggerate their experience and influence to win your business. To protect your business against this, ask questions and place value where it will serve you best. How can they move your project forward? The CRO should be able to guide you with documentation, applications, planning and managing regulatory and clinical meetings, and securing funding to take you from concept all the way to market, and beyond.

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How to Reduce the Risk Associated With a Contract Research Organization

By: Hilary Jewhurst on September 19 2022

Third-party risk management processes can be overwhelming for many small healthcare organizations. The clinical trials process is demanding, as is working to mitigate the risks that could threaten the organization's reputation, production, and patient safety. For these reasons, many sponsoring organizations look to outsource their third-party risk management processes to contract research organizations (CROs).

While the best CROs provide a range of services to fit the healthcare organization's needs, outsourcing to a CRO doesn't remove a sponsoring organization's obligation and accountability for managing vendor risk. That accountability is why third-party due diligence is important for the sponsoring organization and those CROs selected to manage a sponsor's clinical trials .

Sponsoring organizations must ensure that prospective CROs have appropriate and effective processes including robust third-party risk management frameworks and policies. However, it’s up to the CROs to demonstrate rigorous third-party risk management that can make them stand out from their competition.

Vendor Risk Ratings and Due Diligence

Every vendor relationship involves different types and levels of risk, depending on the vendor and the services or products outsourced. The first step to understanding a vendor's risk is identifying and assessing it. Once the risk types and amounts are known, a risk rating or level can be assigned. These risk ratings are typically low, moderate, or high . The level of risk is an important factor for determining what level and type of due diligence is necessary.

For example, a low-risk vendor may only be required to provide basic information. In contrast, a high-risk vendor may be asked to provide extensive SOC reports and details regarding their information security policies. For this reason, it’s important to understand the vendor's level of risk and how it impacts the due diligence process. Remember: the higher the risk, the more rigorous the due diligence should be.

The Importance of Due Diligence for CROs

The process of due diligence involves collecting information about an organization's controls, identifying its inherent risks, and verifying its reputation. Since every vendor relationship involves certain levels and types of risks, it’s crucial to thoroughly evaluate each vendor and their products or services to understand the risks involved.

Performing effective due diligence is essential for identifying potential risks and setting expectations. When vendors access, transmit, process, or store sensitive data or PHI (Protected Health Information), sponsors must ensure they have controls in place to protect that information; this includes CRO vendors. When performing due diligence on their vendors, a CRO must look for weaknesses, vulnerabilities, and risks that the vendor might pose to the sponsor organization and its patients. Identifying these risks is crucial to avoid legal action, fines, and irreparable reputational damages.

During clinical trials, patient safety, privacy, and security are among the top priorities. So, a sponsor organization needs to ensure that the CRO performs robust due diligence on their vendors to protect the trial's integrity and identify any risks before issues arise. CROs that provide thorough due diligence will stand out to sponsors as a worthwhile investment to protect the organization from damages and ensure a healthy vendor relationship.

A Robust Due Diligence Process

During the due diligence process, the CRO may request that the vendor completes a vendor risk questionnaire, which will help develop a better understanding of any potential risks. The CRO should also request a series of documents from the vendor to verify the vendor's reputation , assess controls, and confirm that necessary licenses are up to date.

The documents requested may include:

• Basic information such as the vendor's full legal name, address, and website
• 3 years of audited financial information
• Procedures and policies
• List of subcontractors and fourth parties
• Reputational risk check
• Insurance certificates
• Third-party management policies
• Information security policy
• Biographies of key members of senior management and the organization's owners

The vendor documents and controls should be assessed by subject matter experts in each risk domain. It is common for subject matter experts to possess professional credentials and licenses, making them well suited to evaluate the vendor's control environment.

Although due diligence is a regulatory requirement, it’s also necessary to protect healthcare organizations and their patients from the potentially negative impacts of vendor relationships. Due to the increasing complexity of third-party risk management, smaller organizations may outsource clinical trials (and their associate third-party risk management) to a CRO organization. Sponsoring organizations must carefully vet potential CROs, and CROs seeking to differentiate themselves from their competitors must demonstrate robust processes for managing third-party risks, including risk-based vendor due diligence.

Due diligence is a fundamental component of any TPRM program. In this eBook, we'll break down how to review the most common reports.

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Putting contract research organisations on the radar

Mariëtte van huijstee.

1 Researcher, SOMO (Centre for Research on Multinational Corporations), Amsterdam, The Netherlands, email [email protected]

Nuria Homedes

2 Associate Professor, University of Texas, School of Public Health, USA

There is a trend for pharmaceutical companies to contract third parties to conduct the clinical trials that are needed to test their drugs. This trend is referred to as outsourcing , and the companies that carry out the work are called contract research organisations. In addition, clinical trials are increasingly conducted in non-traditional trial regions, which are mainly low- and middle-income countries. This trend is called offshoring . The combination of outsourcing and offshoring poses serious risks for the ethical treatment of participants in clinical trials.

It is widely agreed that the offshoring of clinical trials to non-traditional trial regions like India and Peru should be scrutinised from an ethical perspective because of the vulnerability of an important part of the trial population. In order to receive medical treatment, these participants often have no alternative but to participate in a clinical trial. Their vulnerability, combined with a lack of independent oversight in many of the countries, creates serious ethical risks.

What happens when offshoring is combined with outsourcing? Do additional ethical risks arise when clinical trials are contracted out? Virtually all pharmaceutical companies publicly declare that they test their drugs in accordance with the highest ethical guidelines, such as the Declaration of Helsinki. But how do pharmaceutical companies safeguard their commitments when they outsource clinical trial activities to contract research organisations (CROs) in poor regions? These are the central questions that are addressed in this paper, which draws on a recent research report that was based on interview and secondary data from India, Argentina, Peru and Brazil, as well as on interviews with pharmaceutical companies and clinical trial experts.

The market for CROs

Nearly 70% of the total research and development (R&D) costs for drugs are accounted for by clinical trials. In 2008, US pharmaceutical companies spent $32.2 billion on trials (Pharmaceutical Research and Manufacturers of America, 2010 ). Pharmaceutical companies are under pressure to bring more new drugs to the market while at the same time they have to cut their R&D budgets. Time is money: the faster a drug is brought to market, the longer the company can enjoy the financial benefits of a patent. The pharmaceutical industry is responding to these challenges by pursuing consolidations in the form of mergers and acquisitions, reducing head counts in R&D, and increasing the outsourcing of R&D to CROs.

The CROs offer pharmaceutical companies access to extra global capacity, to extra knowledge and to new technologies without their having to make huge investments, and enable them to convert large fixed costs into variable costs. Currently, about half of the clinical trial activities of pharmaceutical companies are outsourced to CROs. The worldwide CRO market was estimated to be $24 billion in 2010 (Kim & Kardum, 2010 ). In the past decade, the global spending by pharmaceutical companies on contract clinical services has been growing at an annual rate of 13.4% on average (Tufts Center for the Study of Drug Development, 2010 ).

The CRO sector is highly fragmented, with over 1100 CROs worldwide, although more than two-thirds of all CROs are based in the USA (Cipher, 2008 ). Contract research organisations come in many shapes and sizes. Some specialise in services in certain areas, and some offer the whole spectrum of services in a drug development process around the world. This latter group comprises the global full-service CROs, which have a presence in all emerging markets. The five largest CROs (Quintiles, Covance, PPD, Charles River Laboratories and ICON) hold 45% of the total market between them (Kim & Kardum, 2010 ).

The way the major CROs profile themselves reflects the drivers for outsourcing: they conduct clinical trials faster and at lower costs, and they have established facilities in all new popular trial locations – Latin America, India, China, Central and Eastern Europe and Russia (Jakovcic, 2009 ). These regions are popular for their fast recruitment of trial participants, the presence of a broad spectrum of diseases, the availability of human resources and technical skills, the availability of populations with differing ethnic responses to drugs, who may also be ‘treatment naïve’, and because of the tightening of testing regulations in the traditional test regions (Thomis & Smita, 2006 ).

In the past 5 years, 37.3% of the participants in pivotal trials used for marketing authorisation applications (MAAs) submitted in the European Union (EU) were recruited in non-traditional research countries. Compared with Western Europe and North America – the traditional trial regions – these regions are often less regulated (or offer a regulatory maze), have a less developed healthcare system and have a relatively vulnerable population. Furthermore, our research findings in Argentina, India and Brazil indicate inadequate oversight by authorities and ethics committees.

The clinical trial business is a welcome economic activity in most non-traditional trial regions. In India, as well as in Brazil, the regulatory process has recently been modified to expedite the approval of clinical trials, which is a decisive factor to attract CROs. These organisations can operate without registration or accreditation (or simply registration at the chamber of commerce may be enough to start testing drugs on humans). Currently, all the major CROs are present in the popular trial locations. In Peru, 70% of all trials are conducted by CROs and in Argentina the figure is about 30%.

Ethical risks associated with outsourcing

Clinical trials inherently bring up many ethical issues, irrespective of where the trials are conducted or who is conducting them. This is because they involve exposing humans to health risks for the health benefits of other humans in the future. Clinical trials are crucial for the development of new drugs that might save millions of lives in the future. But certainly not all clinical trials serve this ‘higher’ goal of health for all. Many interests – both economic and non-economic – play a role in clinical trials: those of the sponsor, of the principal investigators, of the CROs, of participants and of future patients. These interests are weighed time and again, and create so-called ethical ‘minefields’ in which participants may suffer.

Experts and practitioners have serious concerns over trade-offs between costs, speed and quality of clinical trials. In many outsourcing models, CROs must bid against other CROs to win research contracts. In competing for contracts, ‘all the incentives are to do [the work] fast’, with the risk of compromising quality. The CROs’ predominant interest is simply to deliver a product (often clinical data that meet market entrance requirements) on time and under budget (Mirowski & Van Horn, 2005 ; Shuchman, 2007 ).

Experts and practitioners are worried about the ‘commodification’ of clinical trials by means of functional outsourcing to CROs: CROs meet their deadlines by breaking the conduct of each study into discrete steps and emphasising their speedy completion. As CRO critics have said, the ‘commodification’ of research projects has begun to ‘kill’ clinical research, and a CRO is reduced to a ‘data-production sweatshop’, where ‘everyone’s very focused on the data’, rather than on the totality of the knowledge required to determine whether a drug is worth pursuing further (Shuchman, 2007 ). Tasks are further scattered and oversight is further burdened when CROs themselves subcontract parts of the clinical trial work. The interview data indicated that such subcontracting does take place, sometimes without regulatory agencies and sponsors being informed.

Oversight by pharmaceutical companies

In our interviews, the pharmaceutical companies that sponsor trials confirmed they had concerns about the performance of CROs. In response they have developed elaborate mechanisms to select, monitor and evaluate CROs in order to guarantee compliance with relevant laws and ethical standards. In fact, these mechanisms greatly increase the costs of CRO–sponsor contracts, which affect the business case for working with CROs, and make some sponsors wary of outsourcing clinical trial management altogether. The fact that some companies refrain from outsourcing because of high monitoring costs leaves us wondering about the stringency of the oversight by those companies that do choose to contract CROs.

At the policy level, the protection of participants in clinical trials managed by CROs in non-traditional trial regions often seems to be in order, but what happens in practice is hard to verify independently, as monitoring reports are not public. Furthermore, European MAA procedures for drugs that have involved testing outside Europe do not include independent verification of the ethical conduct of the trials. This situation of lacking independent oversight obviously leaves a lot of room for improvement in the protection of clinical trial participants in non-traditional trial regions.

Notwithstanding the claims of sponsors, interviews with CROs indicate that the stringency of monitoring mechanisms varies widely among sponsors, which obviously creates opportunities for underperforming CROs. Indeed, stories continue to surface about unethical trials, which supports such concerns (Jenkins, 2010 ; Wemos, 2010 ; Lakhani, 2011 ).

There is no proof that clinical trials executed by CROs breach ethics guidelines more often than other trials. However, the blurring of responsibilities and fragmentation of clinical tasks through contracting and subcontracting, combined with cost and time pressures, clearly increases the risk that ethical treatment of clinical trial participants is given the lowest priority. In this context it remains an area of grave concern that the parties that earn most money with the trials – CROs and sponsors – seem to be the most important monitors in non-traditional trial regions.

• Cipher (2008) Global Contract Research Organization (CRO) Industry: Overview and Trends, 2008 . Available at http://www.cipher-sys.com/Global%20Contract%20Research%20Organizations.pdf (accessed 6 March 2012).
• Jakovcic, K. (2009) The CRO market outlook: emerging markets, leading players and future trends . Business Insights . Available at http://www.marketresearch.com/Business-Insights-v893/CRO-Outlook-Emerging-leading-players-2428184 (accessed 6 March 2012).
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Parexel Announces CEO Succession Plan

DURHAM, N.C., March 18, 2024 (GLOBE NEWSWIRE) -- Parexel, one of the world’s largest clinical research organizations (CROs) providing the full range of Phase I to IV clinical development services, today announced that Jamie Macdonald will retire and transition his role as Chief Executive Officer (CEO) to the company’s Chief Operating and Growth Officer Peyton Howell effective May 15, 2024. Ms. Howell, who joined Parexel in 2018 as Chief Commercial and Strategy Officer, will be appointed to the company’s Board of Directors May 15. Mr. Macdonald will continue on the Board through Dec. 31, 2024, and will remain an industry advisor to EQT and the largest individual investor in Parexel.

“On behalf of EQT, Goldman Sachs Asset Management and the Parexel Board of Directors, I want to congratulate Peyton and thank Jamie for his contributions and outstanding leadership over the past six years,” said Sheri McCoy, Chairperson of the Board. “Jamie guided Parexel through a pivotal time in the company’s evolution, leading it through its successful acquisition by EQT and Goldman Sachs Asset Management in 2021 and achieving industry-leading profit growth across his tenure with the company — outpacing the top-tier CROs during this same period to position Parexel for sustainable growth.”

She continued, “Peyton Howell is a proven strategic leader and strong successor to carry Parexel forward into its next chapter. Her deep understanding of the industry, unmatched energy and passion for improving patient lives and commitment to creating value for shareholders, customers and colleagues make her the ideal candidate to lead Parexel through this exciting next phase. Together, she and Jamie have worked to ensure Parexel is well positioned for the future.”

“It’s been a privilege to lead Parexel during this critical period in the company’s strategic transformation,” said CEO Jamie Macdonald. “Our commitment and focus on the patient have continued to differentiate Parexel, drive our focus on innovation and ultimately strengthen our ability to develop new therapies that enhance and save patient lives. We have an incredibly talented team and leader in Peyton as our next CEO.”

He continued, “On a personal note, I’m proud of my time with Parexel and to have been part of the CRO industry for 30 years. With the company well positioned for growth, now is the right time for me to retire and spend more time with my family. Following the transition, I look forward to continuing to support Parexel as a Board member and remaining an investor. I’m truly grateful for my time with this amazing organization and to have been part of such an incredible team.”

“I’m honored to serve as the next CEO of Parexel,” said Peyton Howell. “With a focus on the patient, a commitment to our customers and the CRO industry’s best colleagues, we have an exciting future ahead. I’m proud of our growth and accomplishments and look forward to working with Jamie on the transition and with the Board and our leadership team to build on this momentum as we execute on our strategic initiatives, continue profitable growth and generate value for our stakeholders.”

As Chief Operating and Growth Officer for Parexel since 2022, Ms. Howell has led the integration and alignment of all aspects of strategy, sales and delivery across the organization to better meet customer needs, build repeat business and lead the market in the next phase of drug development transformation. From 2018 to 2022 she served as Chief Commercial and Strategy Officer, implementing the company’s patient-focused strategy and launching its Biotech business unit in January 2019, which has grown by more than double. Also during her tenure Ms. Howell has made a significant impact in growing the company’s customer relationships, delivering consistent, strong growth in gross new business awards during a period of significant volatility in the life sciences industry.

At an industry leadership level, Ms. Howell currently represents Parexel as Chairperson of the Association of Clinical Research Organizations (ACRO) following several years on the Board. Her 30+ year career in the healthcare industry includes senior leadership positions with AmerisourceBergen (now Cencora), a Fortune 20 company, most recently as President for Health Systems and Specialty Care Solutions, a $50 billion business unit. Prior to AmerisourceBergen, Ms. Howell was a founder of Lash Group, growing the company from an early innovator of patient access services to nearly 5,000 employees and serving as President for nearly 10 years following its acquisition by AmerisourceBergen.

Ms. Howell serves on the Board of Directors of Tandem Diabetes Care (NASDAQ: TNDM), a medical device manufacturer. She holds a master’s in healthcare administration (MHA) from The Ohio State University and in 2020 was named a Luminary by the Healthcare Businesswomen’s Association (HBA).

About Parexel Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere.

Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers quality solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With Heart TM  every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. This approach continues to earn us recognition industrywide, with Parexel being named “Best Contract Research Organization” in November 2023 by an independent panel for Citeline, “Top CRO to Work With” by investigative sites worldwide in the 2023 WCG CenterWatch Global Site Relationship Benchmark Survey and recipient of the 2023 Society for Clinical Research Sites (SCRS) Eagle Award for advancing the clinical research profession through strong site partnerships. For more information, visit parexel.com and follow us on LinkedIn, X, Facebook and Instagram.

MEDIA: Lori Dorer Senior Vice President, Corporate Communications +1 513 496 8121