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Session Chair(s)
Francois Torche, MBA
Chief Product & Technology Officer
CluePoints, Belgium
Learning Objective : Define central statistical monitoring (CSM); Identify how FDA guidance for the conduct of RBM is impacting sponsors; Describe how current technology and manual tracking of data are creating roadblocks in developing effective RBM strategies; Discuss how CSM methods can help identify centers with unusual data, while optimizing on-site monitoring, final submissions, and how resources are deployed.
Speaker(s)
Risk-Based Monitoring Revealed: How an Independent and Objective Assessment of Data Quality Will De-Risk Your Study
Francois Torche, MBA
CluePoints, Belgium
Chief Product & Technology Officer
Beyond RBM: Using a Central Monitoring Application as an Oversight Tool in a Cardiovascular Mega-Trial
Eric Genevois-Marlin, MSC
Sanofi R&D, France
Vice President, Biostatistics and Programming
Realizing the Value of CSM: Showcasing How a Measured Implementation of Central Statistical Monitoring Can Benefit an Organization
Brian J. Nugent, BSN, RN
Gilead Sciences, Inc., United States
Associate Director, Clinical Operations
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