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Wednesday, June 21 • 4:00pm - 5:15pm
#375: Automation and Innovation in Clinical Trial Safety Assessment

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Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

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 Objectives

Discuss some practical ways to use innovative tools to support clinical trial safety monitoring and reporting.


Susan P. Duke, MSc


Removing an ICH Bottleneck: Efficient Safety Assessment Using Computer-Generated Adverse Event Narratives
Richard C. Zink, PhD

How We Do Safety Review Using Spotfire
Wei Wang, MD, MPH

Algorithmic Approach for Real-Time Safety Data Review to Make Safety Management Subject Centric and Reduce Inherent Trial Risk
Vasudeo Ginde, MD

avatar for Susan Duke

Susan Duke

Consultant, Drug Safety Counts LLC
Susan has been active industry-wide in topics relating to quantifying patient safety since 2011 when she joined GSK's pharmacovigilance department's benefit-risk initiative. She is currently co-lead of a cross-functional initiative on safety monitoring. She has authored several publications... Read More →

avatar for Vasudeo Ginde

Vasudeo Ginde

President, Opus Analytics
A physician by training, Dr. Vasudeo Ginde is an eminent clinical research thought leader in India. After playing a pivotal role in setting up Eli Lilly’s Indian clinical research infrastructure in early 1990s, he co-founded the full-service CRO DiagnoSearch in 1995 & currently... Read More →
avatar for Wei Wang

Wei Wang

Senior Research Scientist, Eli Lilly and Company
Wei Wang is the key driver at Lily for implementing interactive visualization for data review and display on study level and integrated data. Wei is currently a biostatistician in the Safety Analytics team in Eli Lilly. She is a member of PhUSE working group on the standard analyses... Read More →
avatar for Richard Zink

Richard Zink

Adjunct Assistant Professor, University of North Carolina at Chapel Hill
Richard C. Zink is Principal Research Statistician Developer in the JMP Life Sciences division at SAS Institute. Prior to SAS, he spent eight years in the pharmaceutical industry. He is the 2018 Chair-Elect for the Biopharmaceutical Section of the American Statistical Association... Read More →

Wednesday June 21, 2017 4:00pm - 5:15pm CDT
S402ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  06: Safety-PV, Session