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Oversight in the Era of E6 (R2)
Session Chair(s)
Melissa Bomben, MS
SVP Clinical Solutions and Strategic Partnerships, WCG North America, United States
This session will outline the characteristics that define common outsourcing models and expose their corresponding risk/benefit ratio with regard to sponsor and CRO oversight. Case studies of proven solutions within each model will be presented and linked to recommendations to achieve enhanced oversight in the era of E6 (R2).
Learning Objective : Discuss the risk/benefit ratio with regard to sponsor and CRO oversight in common outsourcing models; Identify methods to implement improved and more efficient approaches to clinical trial oversight.
Speaker(s)
Cristin MacDonald, PHD
Vice President, Client Delivery, WCG Clinical, United States
Lauren Blomberg
GCP Inspection Lead, Quality and Continuous Improvement, GCTO, Merck & Co., Inc., United States
Ann Marie Dunne, MPH
Director, Quality Operational Capabilities, Global Clinical Operations, Biogen, United States
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