
May 7
In ACRO and TransCelerate BioPharma’s latest collaboration, Cris McDavid (Senior Director, Global Clinical Operations, Parexel) and Tashan Mistree (Senior Director, Business Operations, Office of Chief Medical Officer, GSK) join this week’s episode to discuss the impact of ICH E6(R3) from their different vantage points in the clinical research industry.
Listen to the podcast by Cris McDavid and Tashan Mistree from ACRO Good Clinical Podcast here.
Clinical trials are a key tool for producing the safety and efficacy data that guide new therapies to market. Progress in clinical research relies on those who volunteer to participate, and yet, access to trials is not the same for everyone in the United States. Read the full article featuring Allison Cuff Shimooka from TechTarget…
ICH-E6(R3) represents a shift in mindset when it comes to clinical trials. Rather than trying to control every part of a trial equally, the guideline wants researchers to focus most on factors that are critical to participant safety and the reliability of trial results. It introduces the idea of “proportionality,” meaning more control is applied…
Getz, the Executive Director at the Tufts Center for the Study of Drug Development (CSDD), presented findings from a study they did with TransCelerate BioPharma, which sheds light on the volume and purpose of data collected in clinical trial protocols. His talk centered on a fundamental paradox in modern clinical research: While we have an…