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Central Statistical Monitoring Revealed: How to Enhance Data Quality and 'De-Risk' Studies Through Enhanced Risk-Based Monitoring

Track:
Processes and Technologies for Clinical Research

Day & Time:
June 16, 8:30AM - 10:00AM (Pacific Standard Time)

Session Number:
109

Room Number:
32AB

Level:
Intermediate

Type:
Session

Title:
Central Statistical Monitoring Revealed: How to Enhance Data Quality and 'De-Risk' Studies Through Enhanced Risk-Based Monitoring

Chair(s):
Francois Torche, MBA
Chief Executive Officer
CluePoints, Belgium

Description:
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(s):
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.

Presentation(s) & Speaker(s):
Risk-Based Monitoring Revealed: How an Independent and Objective Assessment of Data Quality Will De-Risk Your Study
Francois Torche, MBA
Chief Executive Officer
CluePoints, Belgium

Beyond RBM: Using a Central Monitoring Application as an Oversight Tool in a Cardiovascular Mega-Trial
Eric Genevois-Marlin, MSc
Vice President, Biostatistics and Programming
Sanofi R&D, France

Realizing the Value of CSM: Showcasing How a Measured Implementation of Central Statistical Monitoring Can Benefit an Organization
Brian J. Nugent, BSN, RN
Associate Director, Clinical Operations
Gilead Sciences, Inc., United States