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New Novotech Report Finds 1,000 HIV Clinical Trials Globally

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Early-Stage Biotech Investments Were Down 40% in 2023: Novotech Whitepaper

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Duchenne Muscular Dystrophy - Global Clinical Trial Landscape (2024)

Rheumatoid arthritis – global clinical trial landscape.

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Clinical trials in China: unlocking the potential of advanced therapies

Endpoints at bio 2023: forging new biotech ties with china.

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Expert Consulting and Multi-Regional Clinical Trial (MRCT) Strategy Rescues Oncology Program

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Investigating Global Clinical Research Perspectives in Precision Oncology

  • Global Prevalence and Clinical Trials Landscape of Duchenne Muscular Dystrophy
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Precision Oncology Clinical Trials & Statistics 2024

  • Immune Checkpoint Inhibitors Global Clinical Trials Landscape (2023)
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  • Assessing the pros and cons of basing clinical trials in today’s European landscape
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Medical and Regulatory Consulting

Patient recruitment and site selection, early phase trials in australia, clinical operations and project management, site management organization (smo), biometrics and data management, virtual clinical trials, real world data, laboratory services, oncology cro services, pharmacometric services, drug development consulting, gmo solutions, liver disease cro services, infectious diseases and vaccines cro services, orphan and rare disease cro services, clinical and regulatory strategy.

Boston, USA -

Novotech Executive Team at J.P. Morgan Healthcare Conference: Global CRO Designed for Biotechs…

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Boston, USA - Novotech, the leading Asia

Duchenne Muscular Dystrophy is a rare genetic disorder characterized by progressive muscle weakness and skeletal degeneration, impacting approximately 1 in 5,000 males globally.

Rheumatoid Arthritis (RA), a chronic autoimmune condition, causes joint pain and swelling.

Arsalan Arif: Hi, everyone. I'm Arsalan Arif with Endpoints News.

John Caroll: Well, good afternoon, good morning, or wherever you may be in the world today

Background   A biotech sponsor based in China with a focus on innovating novel immunotherapy treatments, encountered

What is Precision Oncology and how has the field evolved in recent years?Precision oncology is an area of medicine that uses precise information about a person's genes, proteins, and envir

Explore the transformative role of precision oncology in cancer treatment with Novotech CRO's whitepaper.

Covid-19 Notice important updates

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Suzhou, China

Sydney, Australia

Novotech’s Medical and Regulatory Consulting team offers full range of pre-clinical, regulatory affairs support, medical and pharmacovigilance consulting services.

Novotech relies on years of experience, in-country knowledge and real-life big data to identify and propose the best-performing sites for your study. 

Australia is a preferred destination for early phase trials because of simple and fast regulatory stream and lucrative R&D cash refund scheme.

Novotech’s streamlined and integrated clinical trial services are delivered by a dedicated team of professionals with deep industry and therapeutic area expertise across all phases of clinical development.

Discover the power of clinical excellence with Acrostar's SMO Division, a dedicated entity operating as part of Novotech.

Delivering accurate, high-quality and timely biostatistics in clinical trials services, including statistical planning, analysis and reporting.

How virtual clinical trials can offer patient retention and cost benefits compared to traditional trials.

Accelerating patient recruitment and drug development with real world data (RWD)

Our bioanalytical services assist our customers in every stage of their molecule development.

The landscape of Oncology in Asia-Pacific Biotechnology companies are facing increased challenges around participant recruitment and rete

Our team can assist in all clinical study phases and in study designs ranging from first in human, single ascending dose, multiple ascending dose, drug-drug interaction, bioavailability/bioequivalence, food effect and special population studies.

Novotech Drug Development Consulting is a full-service global product development and strategic regulatory group, providing comprehensive “lab to launch” program development services.

Novotech initiated the first national, privately owned, commercial Institutional Biosafety Committee (IBC) in Australia, successfully accredited b

The landscape of Liver diseases in Asia-Pacific Biotechnology companies consider locations in the Asia-Pacific region, s

Providing Infectious diseases services and Vaccines CRO services Many biotechnology companies look at the Asia-Pacific region for their t

Landscape of Rare and Orphan diseases in Asia-Pacific There may be as many as 8,000 rare diseases, affecting between 6% and 8% of the wor

Many biotechnology companies come to Australia to conduct early phase clinical trials and take advantage of straightforward regulatory streams and

Our workplace culture reflects the passion of our people, and we will support you to develop and achieve at all stages of your career and life.

Novotech is the leading asia-pacific contract research organisation (cro) providing clinical development services across all clinical trial phases and therapeutic areas and global product development and regulatory affairs consulting through our in-house novotech drug development consulting team., there are many reasons people love working at novotech, but when you join it will be our open, inclusive, and flexible work culture that you notice first., we are committed to providing ongoing professional development training, a competitive bonus structure, a supportive work environment, variety in their role, and the opportunity for career development and advancement across all areas of the organisation to our employees., our mission is to create career development opportunity for everyone., we are committed to hiring ambitious and ethical professionals genuinely excited to be a part of the dynamic life sciences industry and who relish a challenge., search novotech.

  • Multiethnic Asian population
  • Streamlined regulatory system and Strong government support
  • Quick start-up timelines
  • Low patient costs and IRB fees

Malaysia, with a population of 31.9 million, features a large and diverse multiethnic population including Malay, Chinese and Indian. Most live in urban areas that are well served by medical facilities.   The country has a highly-regarded health care system and life expectancy/infant mortality rates are comparable with the US and European countries. Bahasa Malaysia is the official language; but English, Chinese and other dialects are widely used. Malaysian healthcare is divided into private and public sectors and boasts advanced technological infrastructure and strong government support for the clinical research sector.   With its improved standards of living, Malaysia is now seeing a higher incidence of lifestyle diseases, along with communicable diseases in rural or disadvantaged areas.   Novotech has established strong clinical teams in Malaysia with deep local knowledge to deliver quality CRO services to biotechnology companies. In addition, it has partnered with key specialist hospital and research facilities including Clinical Research Malaysia as part of its Partner Program, giving Novotech clients direct access to the most active and reputable KOLs, PIs and sites to facilitate study start-up and patient recruitment.   Clinical trials are regulated by the National Pharmaceutical Control Bureau (NPCB)  and reviewed by IRBs, including the Medical Research & Ethics Committee (MREC) for trials using Ministry of Health (MOH) Malaysia facilities; or local IRBs for non-MOH facilities.   Key features of the Malaysian clinical trial landscape include streamlined submission and regulatory processes (in English), quick start-up times, a strong network of experienced KOLs and PIs, and supportive Government policies – all of which have made Malaysia a preferred clinical trial destination.

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Malaysia is George Clinical’s Southeast Asian hub, where we cover neighboring countries of Singapore, Indonesia and the Philippines – accessing a population of almost 400 million multi-ethnic people.

George Clinical

George Clinical In Malaysia

Singapore is a recognized destination for clinical trials, yet other countries are fast emerging as more governments commit to streamlining their clinical research industry. Malaysia implements a universal healthcare system that co-exists with a private healthcare system. Malaysia has a multi-ethnic population of over 30 million, with moderate life expectancy and infant mortality rate. The government has committed funding to improve the healthcare systems in order to support medical tourism and clinical research. The network of Clinical Research Centres, as well as Clinical Research Malaysia, is part of the government effort to improve the country’s infrastructure to support the industry. To date, Malaysia has 90 industry-sponsored research (ISR) trial sites which are approved by the Ministry of Health (MOH) and local IRBs/ IECs, consisting of 11 prime sites network. They are a mixture of public, teaching and private hospitals, and have participated in over 1,000 ISR trials that require ICH GCP compliance.

Why is the country attractive for sponsors to conduct clinical trials?

  • The current Malaysian Economic Transformation Program (ETP) targets clinical research as one of its main drivers in economic growth. Therefore, the government of Malaysia established Clinical Research Malaysia (CRM) with the aim of promoting an increase in the number of clinical trials in Malaysia.
  • CRM supports the clinical research industry to effectively increase the speed, reliability, and delivery of outcomes for all stakeholders involved.
  • Malaysia has inherent benefits to conduct clinical trials such as its large multi-ethnic population that offers genetic diversity
  • Established and good public and private healthcare systems 
  • A consistently increasing number of Good Clinical Practice (GCP) trained and compliant investigators and support staff
  • An established and comprehensive ethical review process by ethics committees 
  • Adherence to intellectual property rights (IPRs) and competitive trial costs compared to other Asian countries. 
  • Malaysia also boasts shorter regulatory and ethics approval timelines for ISR that are comparable with countries like Hong Kong, Japan, Singapore, Taiwan and South Korea
  • Malaysia ranks high globally with one of the best start-up timelines  

Why is George Clinical the CRO of choice for our sponsors in Malaysia?

  • Established in-country network 
  • Experienced staff on local regulations and requirement
  • Engagement with key opinion leaders (KOLs) across various therapeutic areas

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Quick View: Malaysia Aims To Rise As A Global Hub For Clinical Trials And Pharmaceutical Innovation

Pharmaceuticals / Malaysia / Mon 08 Jan, 2024

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The Latest: On January 4 2023, Roche achieved a significant milestone by initiating its pioneering first-in-human (FIH) clinical trials for a rheumatology indication in Malaysia. This marks Malaysia as the first market within the Asia-Pacific region to participate in such studies and positions Malaysia as the seventh global participant in Roche's research efforts. Since 2012, Roche has demonstrated its commitment to advancing medical research in Malaysia through an investment of approximately MYR190.0mn (USD40.9mn) in clinical trials.

Implications: Since the inception of the Clinical Research Malaysia (CRM) in 2012, Malaysia's clinical trial landscape has experienced remarkable growth, hosting over 2,300 sponsored clinical studies to date. The market is increasingly being recognised by drugmakers for its capacity to conduct multi-regional clinical trials, bolstered by world-class investigators, robust, well-established infrastructure and a stringent regulatory framework prioritising patient safety. The launch of Roche's global first-in-human (FIH) trial for a rheumatology indication in Malaysia strongly affirms the market's burgeoning clinical research expertise. This milestone was achieved just two years following the successful completion of CRM's Phase 1 Realisation Project (P1RP) in 2021, a pivotal initiative designed to foster the FIH trial ecosystem within Malaysia. Since then, Malaysia has successfully undertaken one FIH and two First-in-Patient studies with Roche, marking the market’s first FIH trial in rheumatology.

The pioneering FIH study by Roche centers on a novel investigational drug for treating systemic lupus erythematosus, an autoimmune disease causing widespread inflammation and tissue damage. In parallel, CRM and the Pharmaceutical Association of Malaysia (PhAMA) exchanged a memorandum of understanding, reinforcing their mutual commitment to enhancing clinical research talent and capabilities in Malaysia. This collaboration underscores a shared vision to foster a skilled workforce, further solidifying the nation's status as a hub for high-quality clinical research – a positive development for drugmakers. However, Malaysia competes with other countries in the region for clinical trials. Countries like Singapore, South Korea and Taiwan have established strong reputations in clinical research which could pose a challenge for Malaysia to attract international clinical trials.

What’s Next: We believe Malaysia will see an expansion of its clinical research facilities and capabilities as the demand for local trials increases. The regulatory environment will continue to evolve to support the growing clinical trial ecosystem and Malaysia will also aim to forge stronger partnerships and collaborations with international pharmaceutical companies, research institutions and regulatory bodies. Seeing the success of major pharmaceutical companies like Roche, more drugmakers will choose to invest in clinical trials in Malaysia, boosting the market's pharmaceutical sector.

This commentary is published by BMI, a Fitch Solutions company, and is not a comment on Fitch Ratings Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent sources. Fitch Ratings analysts do not share data or information with BMI. Copyright © 2023 Fitch Solutions Group Limited. All rights reserved. 30 North Colonnade, London E14 5GN, UK.

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The perspectives and opinions expressed in this material represent those of the patient advocate only and should not be considered a solicitation, promotion or advertisement for any services of Parexel, or any drugs or therapies, including those under development. Participating in clinical trials for investigational medicines offers patients potential benefits, such as access to cutting-edge treatments and expert medical care, while contributing to medical research. However, risks may include side effects, unpredictable outcomes, and time commitment. Careful assessment of these factors helps patients make informed decisions. The content of this material, including graphics, images and text, is provided for informational purposes only and does not constitute medical advice, diagnosis or treatment. Please consult your healthcare professional for medical advice. The patient advocate has provided their consent for the use and distribution of this content.

Patient Story

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Sara's only symptom was fatigue. But after some routine tests, she was diagnosed with breast cancer.

Now she was the one in need of care — joining the 3.8 million women in the US and many others around the world impacted by breast cancer.

For years she'd worked at a hospital, onboarding new doctors and making care possible for others.

Now she was the one in need of care — joining the 3.8 million women in the US and many other around the world impacted by breast cancer.

She started radiation. A new, promising chemotherapy treatment was also available, so she joined the clinical trial.

That decision changed her life., today, she’s cancer free — and works at parexel to help ensure our trial sites are prepared to meet the needs of patients like her., lives can change when you design oncology trials with speed and precision..

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MORE EXPERTS

Scott Smith, M.D., Ph.D.

Senior Vice Presiden...

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Amy McKee, M.D.

Amy McKee, M.D.

Chief Medical Officer and Global Head, Oncology Center of Excellence

With 11 years of experience from the FDA, Amy provides patient-focused medical and scientific leadership globally at Parexel. She’s an energetic leader with demonstrated ability to build and lead multidisciplinary teams, utilizing novel endpoints and incorporating real-world evidence to accelerate clinical development.

"What differentiates us is that we have that expertise globally. We have experts in Europe. We have experts in Asia. We have experts in the Americas. And so we can cover every region with the kind of expertise that you need for your study."

Our oncology team is 1,000+ strong, with experience across the oncology continuum, to match the needs of your trial.

1000+ Strong

Advanced modeling and simulation allow us to predict drug effects in advance , saving time, money, and resources.

Advanced modeling and simulation

Our experience with oncology clinical trial sites around the world allows us to accelerate study start-up.

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Advanced modeling and simulation

Our application of real-world data allows us to find the right study participants fast.

Four times faster than traditional approaches for a recent client.

Our global regulatory team keeps everything running smoothly.

80+ ex-agency oncology regulators

And our patient-first approach results in deeper, more relevant insights for trial design and execution.

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What can we do to help you change patient lives?

See oncology capabilities Visit all therapeutic areas Explore oncology careers

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We focus on patients, because they inspire us to deliver better trials, faster than ever . So we can make a difference for more patients like Sara.

Who we are,, parexel is proudly among the world’s largest clinical research organizations.

A dedicated CRO providing the full range of Phase I to IV clinical development services  and 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 and sites to design and deliver clinical trials with patients in mind , to make clinical research a care option for anyone, anywhere.

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clinical research malaysia companies

  • Publications
  • Conferences

Malaysia’s Clinical Research Ecosystem

Applied Clinical Trials

Examining the role of Clinical Research Malaysia in advancing industry-sponsored drug development in the country.

clinical research malaysia companies

Evaluating the Current State of Randomized Platform Clinical Trials

Systematic review of 127 recent platform trials showed insufficient reporting of important trial information.

Improving Engagement While Maintaining Data Integrity & Validity

Improving Engagement While Maintaining Data Integrity & Validity

In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.

© putilov_denis - © putilov_denis - stock.adobe.com

Top-Line Data of Phase II/III HEALEY ALS Platform Trial Shows Improvements in Function and Mortality

Despite improvements, results from the study of SLS-005 (IV trehalose), a low molecular weight disaccharide, did not meet statistical significance.

Bringing the Clinical Trials Industry Together

Bringing the Clinical Trials Industry Together

Micah Lieberman, Executive Director, Conferences (CHI) & Co-Founder, VP, Community and Business Development (ClinEco) discusses what ClinEco is and what attendees can expect at SCOPE.

Image credit: Crystal light | stock.adobe.com

Opdivo plus Yervoy Shows Survival Benefit in Patients with Hepatocellular Carcinoma in Phase III CheckMate -9DW Trial

Opdivo plus Yervoy was found to produce a statistically significant and clinically meaningful overall survival improvement compared with sorafenib or lenvatinib in patients with advanced hepatocellular carcinoma.

© Blue Planet Studio - © Blue Planet Studio - stock.adobe.com

Utilizing Generative Artificial Intelligence to Increase the Understandability of Inpatient Discharge Summaries

Results of cross-sectional study of 50 discharge summaries suggest a large language model can be used to increase their understandability.

2 Commerce Drive Cranbury, NJ 08512

609-716-7777

clinical research malaysia companies

Precision Neuroscience Expands Clinical Research In Brain–Computer Interface

NEW YORK, March 22, 2024 (GLOBE NEWSWIRE) -- Brain–computer interface (BCI) company Precision Neuroscience Corporation (Precision) today announced the launch of two new clinical study sites, at Mount Sinai Health System and Perelman School of Medicine at the University of Pennsylvania (Penn Medicine). These pioneering studies represent a major step forward in understanding how the brain controls movement and align closely with Precision’s commitment to transforming the lives of patients with neurological disorders.

The cornerstone of the studies is Precision's brain implant, the Layer 7 Cortical Interface, a high-resolution electrode array comprising 1,024 miniature electrodes spanning an area of 1.5 square centimeters. Embedded in a flexible film that conforms to the brain's surface, the device is engineered to record neural activity at resolutions hundreds of times finer than conventional cortical surface arrays. Its design allows for safe implantation and removal by neurosurgeons without causing harm to delicate brain tissue.

Dr. Ben Rapoport, Chief Science Officer and co-founder of Precision Neuroscience, underscored the significance of these studies in advancing both medical science and patient care. “Mount Sinai and Penn Medicine are major centers of excellence, known for spearheading advancements in neurotechnology,” Rapoport said. “Each of our partners has focused on a unique area of applied neuroscience, and each study leverages the high resolution neural data produced by our arrays to shed light on a different aspect of how the brain works.”

Advancing Scientific Frontiers at Mount Sinai

At Mount Sinai, Precision is collaborating with a team of distinguished researchers led by Dr. Ignacio Saez, Associate Professor at the Icahn School of Medicine and principal investigator of the study. This partnership aims to explore the diverse applications of high-resolution cortical surface arrays in clinical settings, ranging from intraoperative monitoring to neurocritical care.

Initial investigations at Mount Sinai have focused on functional mapping of the motor and sensory cortex using the Layer 7 array. Dr. Fedor Panov, Assistant Professor of Neurosurgery, successfully implanted the device in asleep patients undergoing intracranial procedures, mapping cortical activity at extremely high resolutions, and in two dimensions.

Saez expressed optimism about the potential impact of this research, stating, “Our ability to understand brain function and record human brain activity is often constrained by technical limitations. This new device will provide a uniquely detailed depiction of neural activity, allowing us to obtain exciting insights into how the brain generates thoughts and behavior, and how these are altered in brain disorders. I am hopeful that the insights derived from this high-resolution data will fuel the development of innovative therapeutic approaches for treating neurological and psychiatric conditions.”

The Mount Sinai study aims to enroll up to 15 patients annually.

Deciphering Neural Signals at Penn Medicine

Led by Dr. Iahn Cajigas Gonzales, an assistant professor of neurosurgery at Perelman School of Medicine at the Hospital of the University of Pennsylvania and principal investigator, the study at Penn Medicine focuses on decoding the neural signals underlying hand movement. Cajigas and his team are using Precision's Layer 7 Cortical Interface alongside motion capture technology in order to deepen scientific understanding of how the brain's motor cortex communicates with the rest of the body to produce movement.

During the study, patients undergoing awake neurosurgical procedures, such as deep brain stimulation (DBS) for Parkinson's disease, have the Layer 7 device implanted via the same burr hole through which DBS electrodes are deployed. Patients are then fitted with motion capture gloves, which can record natural reach and grasp kinematics of hand and arm movement with high precision. The patients are instructed to conduct different gesture tasks. Subsequent analysis synchronizes motion capture data with neural recordings captured by the Layer 7, enabling precise predictions of intended hand and arm movements.

The Penn Medicine study aims to enroll up to 15 patients annually.

The Layer 7 is an investigational device that is not available for sale in the United States.

About Precision: Precision Neuroscience is working to provide breakthrough treatments for the millions of people worldwide suffering from neurological illnesses. The company is building the only brain–computer interface designed to be minimally invasive, safely removable, and capable of processing large amounts of data. To learn more about how Precision is connecting human intelligence and artificial intelligence, visit www.precisionneuro.io .

Contact:   [email protected]

clinical research malaysia companies

February 2024 Clinical Trials

Clinical Trials Activity Update for February 2024

  • Posted on 21 Mar 2024

Clinical Trials Activity Update for February 2024

Clinical trials are integral to providing optimal patient care, enhancing medical understanding, and developing new therapeutics as well as improving existing ones. From raising the standard of care for various diseases to laying the foundation of revolutionary medical devices, clinical trials significantly impact the healthcare landscape. As medical challenges turn more complex, clinical trials become increasingly important in addressing the unmet medical needs of a growing patient population, particularly those with chronic and new infectious diseases. 

Let’s explore some significant clinical trial activities of February 2024, poised to transform the healthcare landscape by treating unmet needs of patients.

Launch of PIVOT-006 Trial Offers New Hope for Non-Muscle-Invasive Bladder Cancer (NMIBC) Patients

In February 2024, CG Oncology Inc, a United States-based biotechnology company, announced the launch of the phase 3 PIVOT-006 trial (NCT06111235) to evaluate the efficacy of a novel therapy cretostimogene grenadenorepvec (CG0070) in the management of intermediate-risk non-muscle-invasive  bladder cancer  (NMIBC), following transurethral resection of the bladder tumor (TURBT). This innovative oncolytic immunotherapy might offer a promising treatment option for those with frequent disease recurrence and repetitive surgery. The trial plans to enrol 426 patients across the United States and Canada, with overall recurrence-free survival (RFS) as the primary endpoint. The secondary endpoints of the study are recurrence-free survival at 12 and 24 months, progression-free survival, and the incidence of adverse events. Besides the PIVOT-006 trial, which is expected to reach primary completion in 2028, cretostimogene is involved in other investigative studies focused on different NMIBC populations and combination studies.

According to the data published by the American Cancer Society, it is estimated that around 83,190 new cases of bladder cancer cases will emerge in 2024. Further, it is reported that bladder cancer will be the cause of 16,840 deaths. The rising global burden of this disease is expected to directly impact its treatment market. According to  EMR  calculations, the bladder cancer treatment market size is anticipated to grow at a CAGR of 9.31% during the forecast period of 2024-2032, likely to reach a market value of USD 8.98 billion by 2032.

Expansion of Greenwich LifeSciences’ Flamingo-01 Phase III Trial for Breast Cancer Treatment

On February 14, 2024, Greenwich Lifesciences, Inc., a clinical-stage biopharmaceutical company in the United States, announced the expansion of its Phase III clinical trial, Flamingo-01, which aims to evaluate the efficacy and safety profile of GLSI-100 in HER2/neu positive breast cancer patients. GLSI-100 is a cancer peptide vaccine with a combination of GP2 and GM-CSF, expected to carry therapeutic potential in preventing breast cancer recurrences. Led by Baylor College of Medicine (a medical school and research center in Houston, Texas), the randomized study has around 750 participants and is designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival.

The approval to expand Flamingo-01 in the five European countries including Spain, France, Germany, Italy, and Poland, it enables the activation of 105 sites post-completion of site contracts as well as site initiation visits scheduled as early as March 4, 2024. Moreover, this expansion will allow the trial to recruit up to 150 global sites to advance breast cancer treatment.

India Achieves Major Milestone with Human Clinical Trial of Gene Therapy for Haemophilia A

India made history in the field of medical science by conducting a pioneering human clinical trial of gene therapy for haemophilia A (deficiency in factor VIII or FVIII clotting activity). In this study, a lentiviral vector was utilized to express an FVIII transgene in the patient's haematopoietic stem cells. The trial was held at Christian Medical College (CMC) in Vellore in a collaborative initiative with the Department of Biotechnology, the Centre for Stem Cell Research (a unit of InStem Bengaluru), and Emory University in the United States along with the Christian Medical College.

Patients with haemophilia A are more susceptible to bleeding or experience prolonged bleeding after injury or surgery as they lack a protein required for blood to clot called FVIII. According to the EMR report, the haemophilia A market is likely to attain a value of USD 49.60 billion by 2032 and is anticipated to grow at a CAGR of 22.8% during the forecast period of 2024-2032. There is a growing demand for innovative therapeutic approaches such as gene therapies to treat this life-threatening condition, which is expected to augment gene therapy market growth in the coming years.

Biocomposites Launches Two New Phase II Clinical Trials of STIMULAN VG to Treat Diabetic Foot Osteomyelitis

Biocomposites Ltd, a medical device company headquartered in the United Kingdom, announced the launch of two-Phase II clinical trials of STIMULAN VG (STIMULAN mixed with vancomycin and gentamicin) in the United States. In the BLADE-VG2 trial, the safety and efficacy of STIMULAN VG will be tested to treat diabetic foot osteomyelitis whereas the BLADE-OPU2 trial will evaluate STIMULAN VG’s safety profile and effectiveness in the treatment of stage IV pressure ulcers.

The trials are part of an investigational new drug (IND) application and intend to show the STIMULAN VG’s potential to improve patient outcomes, reduce the incidence of recurrent infection, and minimize the use of antibiotics. The BLADE-VG2 trial has started to recruit patients and the BLADE-OPU2 trial is expected to start shortly. With the growing number of foot osteomyelitis and stage IV pressure ulcer patients, there is an urgent need to investigate the efficacy of such promising treatments that can help in infection management cases and reduce systemic antibiotic use.

Novel CAR T-Cell Therapy Shows Promise in Targeting Ovarian Tumors

In February 2024, Anixa Biosciences, Inc. announced that the first-in-human Phase I study to investigate the efficacy of a novel CAR T-cell therapy in ovarian cancer  patients has started with its second cohort of patients. Conducted through a research partnership with the H. Lee Moffitt Cancer Center and Research Institute, the trial is reported to have an estimated enrolment of 48 patients. The data in the first 3 patients receiving follicle-stimulating hormone receptor (FSHR T)-mediated T cell treatment exhibited positive results leading to the second cohort of patients where the therapy will be examined at triple the dose given in cohort 1.

In this trial, the researchers are directly administering the engineered T cells into the peritoneum, a site for most ovarian tumor lesions to prevent any adverse events. The FSHR-mediated CAR T technology or chimeric endocrine receptor T-cell (CER-T) therapy offers an innovative approach to treat ovarian cancer and other FSHR-expressing tumours by targeting hormone receptors. Although the study is in its initial phase, this CAR T-cell therapy is expected to offer a novel treatment option for patients with ovarian cancer.

Clinical trials act as a robust research tool to advance medical knowledge and improve patient outcomes. Not only do they measure the efficacy of new therapeutics, but they also help healthcare providers weigh the side effects of a treatment against its potential benefits, thereby assisting them in making the best possible treatment plan for the patient. Moreover, with the rise in technological advancements and research endeavours aimed at developing highly efficient therapeutics, the demand and diversity of clinical trials are likely to grow in the near future.

*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.

Global Drug Approvals Update for February 2024

Global Drug Approvals Update for February 2024

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  6. Malaysia Becomes Syneos Health’s First Catalyst Site Network For

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COMMENTS

  1. Clinical Research Organization

    Clinical Research Malaysia (CRM) is a Global Trusted Research Management Organisation established by the Ministry of Health Malaysia in 2012. The organisation is guided by the principles of Humanity, Stability and Sustainability in providing global clinical trial solutions and enabling a thriving clinical research ecosystem in the country.

  2. List of Contract Research Organizations in Malaysia

    United Kingdom. ClinActis. ClinActis Pte. Ltd., is a leading full-service contract research organisation (CRO) in Asia Pacific. We provide clinical trial services to the pharmaceutical, medical device, medical nutrition and biotech companies in Asia Pacific.

  3. Clinical Research Malaysia

    Clinical Research Malaysia. 21,424 followers. 6d. Featuring our esteemed speakers for the Plenary Session at the upcoming CRM Trial Connect 2024! Join us as our speakers share on the potential and ...

  4. Contract Research Organization (CRO) Malaysia

    Malaysia. Suite 25.03, Level 25 Centrepoint South, Mid Valley City,Lingkaran Syed Putra. Malaysia. +603 2201 8282. Map. Exceptional Contract Research Organization (CRO) services in Malaysia by Novotech CRO. Talk to one of our CRO experts today.

  5. George Clinical

    The network of Clinical Research Centres, as well as Clinical Research Malaysia, is part of the government effort to improve the country's infrastructure to support the industry. To date, Malaysia has 90 industry-sponsored research (ISR) trial sites which are approved by the Ministry of Health (MOH) and local IRBs/ IECs, consisting of 11 ...

  6. Malaysian Clinical Research Highest In 2021 With 215 Studies

    Sponsored clinical studies are usually funded by pharmaceutical companies to conduct clinical trials that involve a research treatment or therapy. In Malaysia, sponsored research has been conducted in 220 clinical study sites since 2012, involving Ministry of Health (MOH) facilities, university hospitals, and private medical centres.

  7. Clinical Research Malaysia About

    Our 5 Key Strategies. Clinical Research Malaysia (CRM) is a non-profit company wholly owned by the Government of Malaysia's Ministry of Health. CRM was established in June 2012 to position Malaysia as a preferred global destination for industry-sponsored research (ISR) and to function as an enabler and facilitator to the industry and medical ...

  8. Malaysia's Clinical Research Ecosystem

    Clinical Research MalaysiaCRM is a non-profit company wholly owned by the Ministry of Health. CRM was established in June 2012 to position Malaysia as a preferred global destination for research and to function as an enabler and facilitator to the industry and medical fraternity for the conduct of clinical trials.

  9. Quick View: Malaysia Aims To Rise As A Global Hub For Clinical Trials

    The Latest: On January 4 2023, Roche achieved a significant milestone by initiating its pioneering first-in-human (FIH) clinical trials for a rheumatology indication in Malaysia.This marks Malaysia as the first market within the Asia-Pacific region to participate in such studies and positions Malaysia as the seventh global participant in Roche's research efforts.

  10. Clinical Research Centre

    Ministry of Health Malaysia Institute For Clinical Research Block B4, National Institutes of Health (NIH) No.1, Jalan Setia Murni U13/52, Seksyen U13 40170 Shah Alam, Selangor Darul Ehsan Malaysia Phone: 603-3362 7700 Email: [email protected]

  11. ICON plc

    ICON plc is a global leader in clinical research and development, offering a range of services to the pharmaceutical, biotechnology and medical device industries. ICON has a strong presence in Asia Pacific, with offices and trials in eleven countries, including Australia. Learn more about ICON's history, strategy, and career opportunities on their website.

  12. Demand for local trials propels Malaysia's clinical research facilities

    Malaysia's clinical trial landscape has thrived, hosting over 2,300 sponsored studies since the inception of Clinical Research Malaysia in 2012, says BMI Research.

  13. Clinical Research Malaysia

    Clinical Research Malaysia offers clinical research support for quality studies and promotes global health solutions. Search Crunchbase. Start Free Trial . Chrome Extension. Solutions. ... Asia Clinical Trials Companies . 470 Number of Organizations • $4.2B Total Funding Amount • 567 Number of Investors. Track . Asia-Pacific (APAC) Clinical ...

  14. PDF Growing the Pool of Clinical Research Investigators in Malaysia

    Clinical Research Malaysia (CRM). CRM is a non-profit company acting as a "one-stop" centre to facilitate the growth of industry-sponsored research (ISR). Since the launch of CRM in 2012, it has successfully closed the various gaps within the clinical research ecosystem and continues to address and improve existing unmet needs.

  15. Clinical Research Malaysia Reviews

    Is Clinical Research Malaysia a good company to work for? Clinical Research Malaysia has an overall rating of 4.3 out of 5, based on over 23 reviews left anonymously by employees. 99% of employees would recommend working at Clinical Research Malaysia to a friend and 83% have a positive outlook for the business. This rating has been stable over ...

  16. Clinical Research Malaysia FAQ

    It was previously a unit under Clinical Research Center before it was corporatized into a separate entity on 15 June 2012. It runs as a private company, however it is fully government owned and the members of the Board of Directors are government officials. CRM's vision is to make Malaysia the preferred destination for clinical trials.

  17. CRO & Biopharmaceutical Services

    Parexel is proudly among the world's largestclinical research organizations. A dedicated CRO providing the full range of Phase I to IV clinical development services and leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals works in partnership with biopharmaceutical ...

  18. Clinical Research Malaysia

    Clinical Research Malaysia. Manufacturing · Malaysia · 100 Employees. Established by Malaysian Ministry of Health in 2012, Clinical Research Malaysia exists to advance global health solutions for a brighter, more hopeful future for the people by providing speedy and reliable end-to-end clinical research support for quality studies.

  19. Malaysia's Clinical Research Ecosystem

    Clinical Research Malaysia. CRM is a non-profit company wholly owned by the Ministry of Health. The organization was established in June 2012 to position Malaysia as a preferred global destination for research and to function as an enabler and facilitator to the industry and medical fraternity for the conduct of clinical trials.

  20. Precision Neuroscience Expands Clinical Research In Brain-Computer

    NEW YORK, March 22, 2024 (GLOBE NEWSWIRE) -- Brain-computer interface (BCI) company Precision Neuroscience Corporation (Precision) today announced the launch of two new clinical study sites, at ...

  21. February 2024 Clinical Trials Advancing Healthcare Research

    On February 14, 2024, Greenwich Lifesciences, Inc., a clinical-stage biopharmaceutical company in the United States, announced the expansion of its Phase III clinical trial, Flamingo-01, which aims to evaluate the efficacy and safety profile of GLSI-100 in HER2/neu positive breast cancer patients. GLSI-100 is a cancer peptide vaccine with a ...