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As clinicaltrials become increasingly complex, particularly in decentralized trials and rare disease studies, sponsors experience increased challenges in site selection, forecasting and resourcing, and patient recruitment and enrollment. Discover how AI is used to optimize key aspects of clinicaltrial management.
As a result, biopharma and biotech companies working to bring their drug pipelines to the market require deep expertise from trusted partners to help deliver critical therapies for their patients. Accelerate your drug development and clinicaltrial goals and benefit from our 360° CDMO and CRO solutions and expertise.
Institutional review boards (IRBs) play a crucial role in the ever-evolving field of clinicalresearch. Innovations in fields such as immunotherapy, cancer and chronic diseases owe their existence to clinicaltrials, which judiciously test and evaluate safety and efficacy.
In an era where clinicaltrials are increasingly global, it’s more imperative than ever to leverage international expertise. Data and safety monitoring boards (DSMBs), also known as data monitoring committees (DMCs), play a critical role in overseeing a clinicaltrial’s safety and efficacy.
Each year, FDA selects a limited number of clinicaltrials to fund to help sponsors pursue development of medical products for rare diseases and advance their field. In October, FDA announced seven new clinicaltrial grants awarded in fiscal year (FY) 2024 – including one for a Phase 3 trial – totaling $17.2
Clinicaltrials are the backbone of medical research, enabling the development of new treatments and therapies that can improve patient outcomes. However, conducting successful clinicaltrials requires efficient communication and coordination among various stakeholders.
Food and Drug Administration (FDA)-approved therapies for treating PAH were primarily vasodilators, designed to overcome the imbalance between vasoactive and vasodilator mediators and to restore endothelial cell function. Historically, the available drugs and U.S. None offers a cure for PAH.
Clinicaltrials have significantly increased in complexity over the last 20 years, creating new challenges. Patients are eager to participate in trials but remain largely unaware of their availability despite growing efforts to recruit.
Before any new therapy can be put on the market, it must be tested to ensure its safety and effectiveness, and the research for this process is done through clinicaltrials.
Yet, four out of five care partners of people with neurodegenerative disorders have never been informed of clinicaltrial opportunities , according to a survey of more than 250 caregivers conducted by PPD, the clinicalresearch business of Thermo Fisher Scientific. There’s little time to lose.
As our understanding of the underlying biology of disease grows more sophisticated, emerging therapies operate on increasingly complex biopathological systems and mechanisms. A surrogate endpoint is a marker used in clinicaltrials as a substitute for a direct clinical outcome.
Cell and gene therapy (CGT) studies are rapidly gaining momentum in the Asia-Pacific region, fueled by growing patient demand and a thriving ecosystem of innovation. In China, the high incidence of solid tumors is driving an urgent need for advanced therapies, spurring the push for new treatment approaches.
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From adapting to complex new trial designs to embracing cutting-edge technologies, staying ahead requires a deep understanding of the current landscape. In response, the PPD clinicalresearch business of Thermo Fisher Scientific conducted its third global survey of 150 drug developers to capture a comprehensive view of these evolving trends.
Fortunately, advances in clinicalresearch are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide ClinicalTrials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.
Breaking through research barriers Challenge #1: Small groups of patients Rare diseases impact a small number of individuals, making it difficult to recruit enough participants for clinicaltrials. Developing effective ECs requires more than just matching clinicaltrial inclusion and exclusion criteria within the RWD source.
In the past, these developers mostly used in-house resources for their clinical monitoring and site management capabilities, whereas today they often prefer functional service provider (FSP) or full-service outsourcing (FSO) models, or a hybrid of the two, to ensure on-time and on-budget delivery of clinical operations.
For clinicalresearch professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. Your CRO can also play a crucial role in helping you to understand existing precedents and how they apply to your study and overall development journey.
The success of clinicaltrials hinges on increasing access to participation by all eligible patients, including populations that have been underrepresented due to the barriers highlighted below. Specifically, U.S. Patients underlined the need for transparency by pharma and other related companies to build trust and partnership.
The drug development industry faces rising costs and increasingly complex protocols as top challenges, with 49% of developers citing costs as their primary concern and 39% pointing to protocol complexity as a key hurdle, according to a recent survey of 150 drug developers worldwide by the PPD clinicalresearch business of Thermo Fisher Scientific.
As a proof of concept, a drug designed to target a newly discovered biological node is showing efficacy in treating rare genetic diseases in the kidney, the eye, and the brain and is now making its way to clinicaltrials in collaboration with a pharmaceutical partner. You can learn more about how clinicaltrials work here.
In preparation for World Orphan Drug Congress Europe, we interviewed Nathan Chadwick, Senior Director, Therapeutic Strategy Lead, Rare Disease, and Derek Ansel, MS, LCGC, Vice President, Therapeutic Strategy Lead, Rare Disease, to hear their insights into the current progress in rare disease research and their hopes for 2025.
We already have the first-ever clinical-stage NBD1 stabilizer and a second series of highly potent NBD1 stabilizers that are advancing to Phase 1 this summer. The post Looking for Opportunities to Accelerate ClinicalResearch in Rare Diseases appeared first on LifeSciVC.
Partnering with a CRO that emphasizes the complexity of the patient’s voice and harnesses the nuances of clinicaltrial design is crucial for executing successful clinicalresearch. These data emphasize the need for precise and meaningful body composition endpoints in T2D and obesity clinicaltrials.
The field of clinicalresearch is a dynamic and rapidly evolving one. One way to ensure that you are at the forefront of these developments is by attending clinicalresearch conferences. AACR, founded in 1907, is the world’s oldest and largest professional organization dedicated to advancing cancer research.
If you’re thinking about joining a clinicaltrial, there are many benefits you could look forward to. But how can you tell if clinicaltrials are right for you? We’ve outlined five reasons why joining a clinicaltrial might be in your best interest. You’ll Get Great Medical Care.
Before any new medical treatment, therapy, or device is approved, it must first be tested through clinicalresearch studies. While some research studies seek participants with illnesses or conditions to be studied in the clinicaltrial, it is not always necessary to have a specific illness or condition to participate.
Distinguishing the Roles of Preclinical vs. Clinical CROs in ClinicalResearch Randomized clinicaltrials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline.
The clinicalresearch industry is only becoming more complex and competitive as organizations are inundated with multiple trials and tight deadlines. The clinicaltrial process is both expensive and time-consuming, and ends more often in failure than success. Advarra surveyed 1,000 random U.S. In total, 82.8%
PPD, Thermo Fisher Scientific ’s clinicalresearch business, surveyed more than 150 decision-making leaders at pharmaceutical and biotech companies around the globe to collect key insights on the state of the evolving drug development industry. The opportunity to leverage new technologies in drug development (e.g.,
The number of pediatric patients diagnosed with nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) is on the rise, yet there are currently no approved therapies to treat NAFLD and NASH in adult or pediatric populations. As therapies for the treatment of NASH in adult patients go this year to the U.S.
To advance new therapies, pharmaceutical, biotech, and medical device companies engage contract research organizations (CROs) for their know-how in navigating the complex landscape of drug development and regulatory pathways and to run clinicaltrials.
At Olympian ClinicalResearch we’ve gotten a chance to work with countless Schizophrenia patients over the years through our clinicaltrials, and we know just how untrue many of the common assumptions about Schizophrenia really are. . Myth #2: People with Schizophrenia are violent. Learn More.
These shifts are a prelude to further change and progress in the clinicaltrial landscape in 2024. To get a pulse on the changing industry, the PPD clinicalresearch business of Thermo Fisher Scientific surveyed 150 biotech and biopharma leaders for the second year in a row to illuminate industry trends, challenges and sentiments.
Through their participation in clinicalresearch studies, they have given an extraordinary gift of hope to future generations! Choosing to participate in a research study is a very personal decision. Did you know that without clinicalresearch studies, we would not have new medications or treatments?
In a recent panel discussion at DIA Global , our experts explored how these elements are reshaping clinicalresearch and drug discovery. This can be converted to a clinicaltrial simulator, which can model a clinicaltrial before the trial design is finalized and initiated.
However, some industries like healthcare and clinicalresearch have had a more fragmented experience in the adoption and seamlessness of their digital experience. Nowhere is this more painful than in clinicaltrials, the backbone of drug development. However, it is often unengaging, cumbersome, and manual.
Introduction Worldwide ClinicalTrials vs. Vial. Worldwide ClinicalTrials is a mid-size, full-service global contract research organization (CRO) that works with biotech and pharma to advance new medications. Other therapeutic areas include cell and gene therapy. How do they stack up?
Much of what we discuss I covered in my presentation, “Leveraging Genetics to Support Rare Disease ClinicalTrials,” at last year’s World Orphan Drug Congress (WODC) EU. The clinicalresearch industry has an opportunity to better partner with genetics providers, clinicians, and genetic counselors to drive stronger enrollment pathways.
Although several corticosteroid treatments are available as first-line treatments, drug developers continue to seek more effective therapies to improve the wellbeing of those diagnosed with atopic dermatitis. Sponsors leverage e-consent, televisits and remote assessments to enable remote clinicaltrials without compromising efficiency.
In the clinicalresearch space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinicaltrials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinicaltrials.
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In this interview, she discusses her path to becoming a physician and clinicalresearcher, the obstacles she faced, and her dedication to improving outcomes for cancer patients. Dr Hingorani also shares insights into the strengths women bring to STEM, the importance of mentorship, and her vision for the future of oncology research.
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