
Mar 7
03/17/2025
Every International Women’s Day invites reflection: Where have we made strides toward equity, and where do critical gaps remain? In clinical research, we see clear and sometimes sobering examples of how important these reflections can be. Until 1993, women weren’t even required to be included in U.S. clinical trials — an eye-opening fact that illustrates how recently the pursuit of truly representative research began.
Read the full article by Allison Cuff Shimooka from MedCity 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…