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Automation and Innovation in Clinical Trial Safety Assessment
Session Chair(s)
Susan Mayo, MS
Senior Mathematical Statistician, CDER Office of Biostatistics
FDA, United States
Many aspects of monitoring and assessing safety data are resource intensive and becoming more so. For example, changes in laws such as the U.S. IND safety reporting rule have resulted in ever-growing demands on sponsors. The current model of adding more staff and using the same process and tools is not sustainable. In this session we will look to innovation and technology for practical solutions to support clinical trial safety monitoring and reporting needs.
Learning Objective : Discuss some practical ways to use innovative tools to support clinical trial safety monitoring and reporting.
Speaker(s)
Removing an ICH Bottleneck: Efficient Safety Assessment Using Computer-Generated Adverse Event Narratives
Richard Zink, PhD
JMP Statistical Discovery, United States
Principal Research Statistician
How We Do Safety Review Using Spotfire
Wei Wang, MD, MPH
Eli Lilly and Company, Canada
Senior Research Scientist
Algorithmic Approach for Real-Time Safety Data Review to Make Safety Management Subject Centric and Reduce Inherent Trial Risk
Vasudeo Ginde, MD
DiagnoSearch Life Sciences, India
President
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