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Central Statistical Monitoring Revealed: How to Enhance Data Quality and 'De-Risk' Studies Through Enhanced Risk-Based Monitoring
Session Chair(s)
Francois Torche, MBA
Chief Product & Technology Officer, CluePoints, Belgium
The session explores the role of central statistical monitoring in risk-based monitoring (RBM) strategies. The presentations will help sponsors improve data quality by identifying anomalies earlier and addressing issues as they are uncovered to de-risk studies and decrease cost/resource inefficiencies.
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)
Francois Torche, MBA
Chief Product & Technology Officer, CluePoints, Belgium
Risk-Based Monitoring Revealed: How an Independent and Objective Assessment of Data Quality Will De-Risk Your Study
Eric Genevois-Marlin, MSC
Vice President, Biostatistics and Programming, Sanofi R&D, France
Beyond RBM: Using a Central Monitoring Application as an Oversight Tool in a Cardiovascular Mega-Trial
Brian J. Nugent, BSN, RN
Associate Director, Clinical Operations, Gilead Sciences, Inc., United States
Realizing the Value of CSM: Showcasing How a Measured Implementation of Central Statistical Monitoring Can Benefit an Organization
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