
Feb 25
03/04/2025
The 2025 SCOPE Summit brought together industry leaders to explore integrating real-world data into clinical trials, focusing on pragmatic trials as a transformative approach. Key discussions revolved around regulatory initiatives, innovative trial designs, and operational strategies to enhance the applicability of clinical research in real-world settings. The summit highlighted the potential of pragmatic trials to bridge the gap between clinical research and practice, offering insights into how these trials can streamline processes, reduce burdens, and improve patient outcomes.
Read the full article from Clinical Trial Vanguard 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…