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The Pennsylvania Convention Center

Jun 14, 2026 7:00 AM - Jun 18, 2026 3:00 PM

1101 Arch Street, Philadelphia, PA 19107, USA

DIA 2026 Global Annual Meeting

Enhancing Clinical Trial Oversight: Using Statistical Outlier Detection with Generative AI for Protocol Deviation Analysis

Session Chair(s)

Ioannis  Spyroglou, PHD

Ioannis Spyroglou, PHD

Associate Director, Data Science

MSD, United States

In this session, we demonstrate an integrated approach that uses bootstrap-based statistical outlier detection and generative AI to identify and characterize clinical investigator sites that underreport or overreport protocol deviations.

Learning Objective : Understanding the core principles of Gen AI; Practical considerations for implementing AI for clinical trial oversight; Illustrate how combing a statistical bootstrap-based method with Gen AI can identify clinical investigator sites that significantly underreport or overreport clinical protocol deviations.

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