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Tuesday, June 16 • 9:30am - 10:30am
#209 L: Data Driven Monitoring Enabled Through Analytics and Quality Risk Management

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-655-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.


Stephen Young, MSc


Leveraging Analytics to Ensure Data Quality and Integrity
Stephen Young, MSc

The Case for Remote Source Data Verification
Karen Ooms, MS

Impact of Advanced Analytics Using Artificial Intelligence on Clinical Trial Management
Patrick McManus, MSc

avatar for Stephen Young

Stephen Young

Chief Scientific Officer, CluePoints
As Chief Scientific Officer for CluePoints, Steve oversees the research and development of advanced methods for data analytics, data surveillance and risk management, along with providing guidance to customers in RBQM methodology and best practices. Steve worked for three bio-pharmaceutical... Read More →
avatar for Patrick McManus

Patrick McManus

Chief Development Officer, Exom Group Srl
Holding a Master of Science in Clinical Research from the Danube University Krems and a diploma in Business Administration and Computational Sciences from the Academy of Public and Business Administration in Munich Patrick is bringing more than 12 years of experience in Business Development... Read More →
avatar for Karen Ooms

Karen Ooms

Executive Vice President and Head of Statistics, Quanticate
Karen Ooms is a statistician with over 30 years experience, including 20 years in clinical research and development. At the start of her career, she was lucky enough to join Rothamsted Experimental Station's Statistics Department, benefitting from the rich vein of knowledge developed... Read More →

Tuesday June 16, 2020 9:30am - 10:30am EDT
TBD Virtual Event Horsham, PA 19044