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Implementing Risk-Based Monitoring: Best Practices from Pharmaceutical Industries to Contract Research Organizations
Session Chair(s)
Warren H. Pence
Associate Director, Adaptive and Intelligent Monitoring, PPD, Inc, United States
This session will provide attendees with practical and useful “take-home” information and best practices that can be used by their organizations in the development and implementation of a risk-based monitoring (RBM) strategy.
Learning Objective : Describe management of study risk at a holistic level including management of study risk through ongoing site quality assessments; Incorporate remote monitoring methods using best practices in a risk-based monitoring (RBM) strategy, taking challenges into account; Apply best practices and tools to aid sponsor-contract research organization collaborations in implementation of RBM.
Speaker(s)
Implementation of Off-Site Monitoring: Successes and Challenges
Mary Arnould, BSN, MSN
Director, Clinical Science Operations, Astellas, United States
Elements of Successful Partnering to Execute RBM: A Biopharmaceutical Company Perspective
Peggy Zavala, MHA
Associate Director, Clinical Monitoring-Americas, Celgene Corporation, United States
Managing Study Risk Through Site Health/Quality
Warren H. Pence
Associate Director, Adaptive and Intelligent Monitoring, PPD, Inc, United States
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