
Feb 5
A panel of experts from inside several major pharma companies discussed regulatory initiatives around pragmatic trials in depth at the recent Summit for Clinical Trial Ops Executives (SCOPE). “I got a fever and the only prescription is more pragmatic trials,” quipped Henry Wei, M.D., head of development innovation at Regeneron and a major fan of TransCelerate’s recent “tabletop exercise” with the U.S. Food and Drug Administration (FDA) as well as the agency’s CDER Center for Clinical Trial Innovation (C3TI) demonstration project focused on the topic.
Read the full article from Clinical Research News here.
In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate…
For decades, women were significantly underrepresented in clinical trials. Recent years have seen improvement, but there are lingering gaps in our collective understanding of how therapies work across sexes, life stages, health conditions and care settings. Read the full article by Jeneen Donadeo from PharmaTimes here.
If you’ve begun combing through the new ICH GCP E6(R3) guidelines to understand how the updates will affect your clinical research practices and feel just a little lost or overwhelmed, you’ve got help. TransCelerate BioPharma, in a partnership with the Association of Clinical Research Organizations (ACRO), has designed and released 13 tools to support E6(R3) adoption across…