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
A surrogate endpoint is a marker used in clinicaltrials as a substitute for a direct clinical outcome. Diagnostic biomarkers typically confirm or establish a diagnosis and are often used in selecting patient populations for clinicaltrials. ClinicalPharmacology and Therapeutics. Rodrigues AD.
AI holds the potential to revolutionise different aspects of healthcare, particularly in the realm of clinicaltrials. By leveraging AI technologies, we could create a more accessible and equitable approach to clinicaltrials, breaking down barriers to participation and ensuring diverse representation among participants.
“James’ proven leadership skills, and deep knowledge of all phases of clinicalresearch, will be invaluable in delivering expert guidance for our clients along their early-phase clinical journey,” said Ingrid Holmes, Vice President, Clinical Operations, Altasciences.
Adherence to harmonized pharmacy-specific SOPs based on cGMP principles at our three clinicalpharmacology units. Clinical Supply Manufacturing Integration with our manufacturing team, ensuring flexibility and adaptability to meet the evolving needs of your studies throughout your drug development program or study.
How Improving Diversity Can Benefit ClinicalTrials pmjackson Wed, 07/31/2024 - 19:19 In July 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinicaltrials, which is expected to become a final guidance by June 2025.
One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases. However, with rare diseases there may be no available treatments that could serve as SoC or active control in a clinicaltrial and assigning patients to placebo may be unethical.
We wish the team at Ischemix continued success on the next Phase of clinicalresearch.” Julie-Ann Cabana Altasciences +1 514 601-9763 jcabana@altasciences.com Date of publication August 30, 2023 Weight 1 Tags ClinicalTrials Altasciences helps sponsors get better drugs to the people who need them, faster.
12/29/2023 FDORA, Section 3602 ClinicalTrials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinicaltrials of new drugs. FDA is directed to issue new draft guidance or update existing guidance regarding Diversity Action Plans for clinical studies.
This is another study that is strongly supportive of replication and further development, including clinicaltrial development. Gauthier Bouche & Pan Pantziarka Gauthier Bouche (MD) is Director of ClinicalResearch at the Anticancer Fund. You will automatically receive updates on this topic in your mailbox.
EPA March 1 FDA Budget FDA’s budget authority will expire as of midnight on March 1 POLITICO March 7 Guidance Expiration FDA’s Guidance on Assessing Covid-19-related symptoms in clinicaltrials of products intended to treat the disease expires.
District Court March 7 Guidance Expiration FDA’s Guidance on Assessing Covid-19-related symptoms in clinicaltrials of products intended to treat the disease expires. FDA) FDA required to have resolved dispute with Vanda Pharmaceuticals or hold a hearing.
These advances are reshaping how pharmaceutical and biotechnology companies approach clinicaltrial design, with a focus on patient-centric dosing strategies. This article explores how innovations in precision medicine are reshaping clinicaltrials, followed by a discussion on Project Optimus and its impact on dose optimisation.
Meet Luke Piggott Luke Piggott is Principal Scientist at Debiopharm, where he plays a key role in driving clinical and scientific research progress. With extensive experience in developing novel therapeutics, spanning discovery to clinicaltrials, he oversees both preclinical and clinicalpharmacology of assets from Phase I to III.
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