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Risk-Based Monitoring: From Concept to Practice
Session Chair(s)
Nicholas Alp, MD, PhD, FRCP
Vice President, ICON Consulting Services
Icon Clinical Research, Inc, United Kingdom
This forum will explore risk-based monitoring, including adapting internal processes and working with third-party providers. Pharmaceutical and CRO experts, with direct experience of working together on these initiatives, will present and lead an interactive discussion.
Learning Objective : Describe the benefits and challenges of implementing risk-based monitoring; Discuss the various approaches to integrate centralized, offsite, and onsite monitoring, including the relative benefits and limitations; Discuss learnings from study selection, through execution, to submission; Describe the impact on the role of the monitor in terms of skills, capabilities, and change management.
Speaker(s)
Successful Messaging for Stakeholders and Decision Makers
Thomas R. Provencher
UCB, United States
Senior Director, Global Clinical Sciences and Operations.
Models, Processes and Sourcing for Risk-Based Monitoring
Nicole R Sheetz, PharmD
Gilead, United States
Senior Director, Clinical Development Technology and Innovation
Driving Change Management in Risk-Based Monitoring
Brett Wilson
Pfizer Inc, Canada
Senior Director, Global Biometrics and Data Management
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