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How Statistics Can Help Improve Data Quality: ICH E6 R2
Session Chair(s)
Cheng Su, PHD
Executive Director, Data Sciences and Analytics
Biomarin Pharmaceutical, United States
ICH E6 (R2) guidance stresses the importance of centralized monitoring, especially by leveraging statistical analyses in order to assess data quality. This session will discuss how statistical methodology fits in the overall quality risk management strategy for the trial portfolio.
Learning Objective : Discuss centralized statistical monitoring approaches and their impacts to data quality and integrity.
Speaker(s)
Using Appropriate Count-Based Statistical Models for KPIs, Risk Metrics, QTLs, etc.
Michael Farnum, PHD, MS
Covance, United States
Senior Director
ICH E6 R2: How Statistics Can Help Improve Data Quality
Steve Young, MSC
CluePoints, United States
Chief Scientific Officer
Centralized Statistical Monitoring: A Large Pharma's Approach
Taras Carpiac, MBA
Amgen, Inc., United States
Executive Director, Innovation and Global Development Operations