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Data Driven Monitoring Enabled Through Analytics and Quality Risk Management
Session Chair(s)
Steve Young, MSC
Chief Scientific Officer
CluePoints, United States
ICH E6 (R2) has set an expectation for the clinical research industry to implement Risk-Based Quality Management (RBQM), including a call for increased use of centralized and remote methods of monitoring study conduct and data quality. In this session we will learn about and explore various innovative data-driven methods being implemented to enable a more effective and efficient approach to quality oversight and monitoring of clinical trials.
Learning Objective : Describe several data-driven approaches to enable more effective and efficient oversight of clinical trials; Discuss both the benefits and challenges associated with these methods.
Speaker(s)
Leveraging Analytics to Ensure Data Quality and Integrity
Steve Young, MSC
CluePoints, United States
Chief Scientific Officer
The Case for Remote Source Data Verification
Karen Ooms, MS
Quanticate, United Kingdom
Executive Vice President and Head of Statistics
Impact of Advanced Analytics Using Artificial Intelligence on Clinical Trial Management
Patrick McManus, MSC
Exom Group Srl, Italy
Chief Development Officer