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Topic-Contributed Paper Session

Anomalous data detection through AI/ML

Sun, Aug 3, 4:00 PM - 5:50 PM Room CC-208A Music City Center

Yuxi ZhaoOrganizerMaria KudelaChair

Biopharmaceutical Section co: Section on Medical Devices and Diagnosticsco: ENAR Applied

5 Presentations

Anomaly detection through mixture of agents Generative AI

4:05 PM - 4:25 PM

Yuxi Zhao (Pfizer)

Implementing ML/AI Methods in Quality Tolerance Limits (QTLs) and Clinical Trial Monitoring

4:25 PM - 4:45 PM

Jianchang Lin (Takeda)

Leveraging AI-assisted Central Statistical Monitoring to Elevate Clinical Trial Oversight and Data Quality

4:45 PM - 5:05 PM

Jingjing Ye (BeiGene)

Co-authors: Jingjing Ye (BeiGene)

Open-Source Risk-Based Quality Management (openRBQM) Framework for Clinical Trial Data Monitoring with AI/ML Extensions

5:05 PM - 5:25 PM

Zhongkai Wang (Gilead Sciences)

Co-authors: Jeremy Wildfire, George Wu (Gilead Sciences)

Risk-Based Quality Management (RBQM)

Outliers in Survival Analysis: A Clustering Framework and Error Bounds for Conditional Kaplan-Meier Estimators

5:25 PM - 5:45 PM

George Chen (Carnegie Mellon University)

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