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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)
Steve Young, MSc
Chief Scientific Officer, CluePoints, United States
Leveraging Analytics to Ensure Data Quality and Integrity
Karen Ooms, MS
Executive Vice President and Head of Statistics, Quanticate, United Kingdom
The Case for Remote Source Data Verification
Patrick McManus, MSc
Chief Development Officer, Exom Group Srl, Italy
Impact of Advanced Analytics Using Artificial Intelligence on Clinical Trial Management
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