Commonwealth Informatics announced that it has been contracted by the FDA to provide consulting services and technical assistance.
Commonwealth Informatics announced that it has been contracted by the FDA to provide consulting services and technical assistance. The company will support quantitative signal detection by the FDA Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).
Read the full release here
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In 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 to these guidelines.