Applied Clinical Trials Digital Edition - February 2011
INFORMATION TECHNOLOGY : A Risk-Based Approach for Computer Systems Validation SITES : Trial Monitoring - Source Document Verification REGULATORY : FDA's Guidance on Patient-Reported Outcomes ALSO IN THIS ISSUE : FDA's Oversight Capabilities Increased, Influenza Warning Issued, Cloud Computing: A Reality?, Guidance Says Focus on the Patient
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.
