This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
Generative artificial intelligence (AI) has captured global attention for its transformative potential across industries, and nowhere is the promise greater — or more fraught — than in health care and clinicalresearch. Accelerate your clinicalresearch with our drug development digital solutions from Thermo Fisher Scientific.
By: Juliane Mills, Senior Director, Therapeutic Strategy Lead, Rare Disease The rise of patient-led clinicalresearch, particularly in rare disease, represents a significant shift in the clinical trial landscape. Why Is There an Increase in Patient-Led Rare Disease Research?
Chief Executive Officer Steve Herne has spent more than 25 years in clinicalresearch, with senior roles at WCG, Bioclinica and Covance. AI with a human purpose Herne speaks about AI in clinicalresearch with pragmatic focus. Unlearn is one of the few companies applying this approach at scale.
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. This aims to ensure that treatments are effective across varied demographics and to address historical gaps in clinicalresearch.
Clinicalresearch has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management.
It is crucial to determine whether you will be working with a CDMO for discovery and drug development all the way through approvals and commercialization or if your work with a CDMO will begin with preclinical development or clinicalresearch. Range of Services The range of services offered by a CDMO is another vital criterion.
Leveraging the extensive breadth of available data to identify entities and relationships across data sources, clinicalresearch experts, therapeutic specialists, machine learning (ML) engineers and others can collectively evaluate areas of interest that may create new opportunities for the asset and a broader clinical strategy.
FY2024 Awardees & Observations For the FY2024 Orphan Products Clinical Trials Grants Program, FDA received 51 grant applications and awarded only seven new clinical trials a grant, providing more than $17.2 million to clinicalresearchers over the next four years to advance the development of medical products for rare diseases.
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 clinical trials. DCEs typically produce population-level estimates and require large samples to be robust.
About the author Dr Cyril Clarke, Vice President, Therapeutic Area, GMI Drug Development and Consulting, ICON Biotech Clarke is a clinical pharmacologist with over 30 years experience in clinicalresearch; seventeen of which are within industrial clinical pharmacology.
Companies can benefit from solutions such as our Accelerator Drug Development, leveraging the combined strength of Thermo Fisher Scientific’s 360˚ Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) services , which provides CDMO, CRO and clinical trial supply chain capabilities that further streamline (..)
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.
About us The PPD clinicalresearch business of Thermo Fisher Scientific , the world leader in serving science, enables our customers to accelerate innovation and increase drug development productivity.
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.
In Part 2 of our conversation with Layla Hosseini-Gerami, Chief Data Science Officer at Ignota Labs , we explore the many forms of toxicity and how AI-powered tools like omics and cell painting are transforming early prediction in pre-clinicalresearch.
These innovations promise to enhance the precision and efficacy of early-stage research, setting a solid foundation for subsequent clinical applications and enabling the development of more personalized medicine.
Fortunately, advances in clinicalresearch are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.
Clinicalresearch generates vast amounts of diverse data from laboratory tests, patients, medical equipment, and outside sources. By organising and analysing this information, researchers can extract actionable insights that improve patient outcomes, data accuracy, drug efficacy and speed up trials.
One of the most important factors to consider during the course of your early-phase clinicalresearch is drug-drug interactions (DDIs), which occurs when one drug alters the effect of another, either by reducing its effectiveness or elevating systemic concentrations to potentially dangerous levelsultimately causing side effects.
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.
Based on these data, it’s reasonable to expect that lonvo-z could enable patients to be free from both physical attacks and the daily burden of prophylactic treatments, offering them greater peace of mind and a significant improvement in their overall well-being.”
I take responsibility for identifying pre-clinicalresearch that can support our clinical programs, as well as designing and overseeing its execution, he explains. It takes a family to develop a drug Trembles role at Poolbeg is multifaceted, reflecting the collaborative ethos of the companys scientific team.
Global Genes: RARE Concierge n-Lorem Foundation Genetic and Rare Disease Information Center Genetic Alliance My Gene2 Undiagnosed Diseases Network Rare Genomics Institute Rare Disease ClinicalResearch Network How can I sign up myself/my loved one to participate in clinical trials?
2024 has been a year of growth and evolution in clinicalresearch. These topics include perspectives on how artificial intelligence (AI) will be leveraged in clinicalresearch, key regulatory trends shaping the industry, the movements of site consolidation, the continued challenges (and potential solutions) of study startup, and more.
The PPD clinicalresearch business of Thermo Fisher Scientific is well-practiced at navigating complex regulatory relationships and has the global resources needed to achieve success, even across borders. The right CRO partner is often the key to approaching these strategies with the care and expertise they require.
This approach provides sponsors with the agility, efficiency and speed needed to expand clinicalresearch into emerging markets or remote areas with highly qualified professionals in a cost-efficient manner.
10 areas that may impact your organization The third revision (R3) of the ICH E6 Guideline for Good Clinical Practice represents a significant modernization of global clinicalresearch standards.
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 clinical trials, which judiciously test and evaluate safety and efficacy.
Phenomix Sciences, built on over a decade of clinicalresearch at the Mayo Clinic, is disrupting this outdated approach. The research demonstrated that obesity is not one disease, but many; each of which should be treated with different interventions, says Bagnall.
This collaborative spirit can lead to developing novel methodologies and strategies for monitoring and evaluating clinical trials, ultimately advancing the field of clinicalresearch. This strategy is indispensable for advancing the clinicalresearch field and ultimately improving patient outcomes across the globe.
FSP solutions are being more frequently utilized by biotech companies Biotech companies employ contract research organizations (CROs) to handle trial-related functions and services, often delivered through a full-service outsourcing (FSO) model, an FSP model or a mixed model combining both. FSP outsourcing is growing faster than FSO.
Take a look at quote from their partnership announcement below: The project represents a transformative step in expanding our understanding of KAND by incorporating continuous, real-world data collection into an already robust clinicalresearch program.
Dr. Jason Westin, Professor of Lymphoma and Director of ClinicalResearch at MD Anderson Cancer Center , remarked on the potential paradigm shift this combination could usher in: “There remains a clear need for effective and well-tolerated treatments for people with this difficult-to-treat disease.
Wearable technologies have become a driving force in modern healthcare, transforming how data is collected, monitored, and analysed in clinicalresearch.
These technologies are helping pave the way toward more objective, reliable tools for clinicalresearch. As these models continue to evolve in both accuracy and accessibility, they offer promise for clinicians seeking faster and more objective assessments in clinical and research settings.
UCB and Biogen are continuing their extensive clinicalresearch program to fully define dapirolizumab pegol’s role in SLE treatment. A second Phase 3 trial is currently underway to further validate these results and hopefully enable eventual submission to regulators for approval.
Its important for your clinicalresearch organization (CRO) to continually assess and invest in capabilities that help drive the success of your clinical program. There are three core areas we are strategically addressing this year. They include: 1.
Clinical science liaison (CSL): At the PPD clinicalresearch business of Thermo Fisher Scientific, the CSL represents sponsors, interacting with sites from feasibility through recruitment. Thermo Fisher Scientific’s PPD clinicalresearch business has extensive experience spanning many respiratory diseases, including IPF.
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.
He holds a BS in pharmaceutical sciences from the University of Mumbai and an MS in clinicalresearch & administration from George Washington University, equipping him with the expertise to drive significant advancements in clinicalresearch for a healthier tomorrow.
Expertise that accelerates your clinical development success The PPD clinicalresearch business of Thermo Fisher Scientific has significant experience in customized Phase I-IV metabolic clinical trials. Were applying that expertise and commitment to every aspect of developing and running successful GLP-1 studies.
Clinicalresearch Completed phase II clinical trials in otherwise healthy patients with genital herpes A Double-blind Randomized Placebo Controlled Dose-finding Trial to Investigate Different Doses of a New Antiviral Drug in Subjects With Genital HSV Type 2 Infection. [8]
The landscape of Indian clinical trial regulations has undergone a profound transformation over the past two decades. Once perceived as a regulatory gray zone, the Indian clinicalresearch ecosystem has […] The post A Closer Look at Compliance and Regulations for Drug Clinical Trials in India appeared first on ProRelix Research.
We organize all of the trending information in your field so you don't have to. Join 15,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content