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Session 8 Track 3: Analytical Driven Trial Design
Session Chair(s)
Joanne Malia, MS, MSc
Director, Development Records Management
Regeneron Pharmaceuticals, United States
This session will discuss current automation and analytics to streamline and enhance quality of documentation for both pre-approval and post-approval activities. The first presentation will discuss how to better design clinical trial protocols and the second presentation will discuss the benefits of automation in Pharmacovigilance aggregate report writing.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Discuss how to use analytics to improve clinical trial design
- Evaluate real-world time saving solutions to reduce your aggregate report writing by more than 50%
- Identify strategies to reduce or manage risk in regulatory compliance by incorporating knowledge management
Speaker(s)
Analytic Driven Trial Design: Are We There Yet?
Robert DiCicco, PharmD
TransCelerate Biopharma Inc., United States
Vice President, Portfolio Management
Automation, Efficiency, and Risk Mitigation in Regulatory Aggregate Report Writing
Kristen Mandello, DVM
Zoetis, United States
Global PV, Signal Detection Manager
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