Implications of Mid-Study Clinical Trial Protocol Changes
Medidata & Tufts Center for the Study of Drug Development announced results of a study on the impact of protocol amendmends made while a clinical trial is underway. The study discussed their avoidability, costs and time delays.
Read the full release here
Read more in Kenneth Getz’s column this month here
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Unifying Industry to Better Understand GCP Guidance
May 7th 2025Podcast
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 to these guidelines.
