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Session 2: Opportunities and Challenges Faced by Academia and Industry in Meeting Disclosure Obligations: An Overview of Policy, Process and Technology
Session Chair(s)
Karen Hartman, MSN, RN
Research Compliance Officer
Mayo Clinic, United States
Marla Jo Brickman, PhD
Senior Director - Clinical Data Transparency/Compassionate Access Lead
Pfizer Inc, United States
With the ever expanding requirements for study registration and results postings across multiple registries, the need for clearly defined institutional policies and efficient processes to ensure timely compliance with regulations, as well as, consistency of content is of critical importance to study sponsors. While the requirements are the same, academia and industry face unique challenges in meeting these disclosure obligations. This session will provide an overview of how academia and industry approach policy development, process implementation and their use of technology.
Speaker(s)
An Academic Medical Center Perspective
Sarah A. White, MPH
MRCT Center, United States
Executive Director
One Company’s Approach to Clinical Trial Disclosure
Marla Jo Brickman, PhD
Pfizer Inc, United States
Senior Director - Clinical Data Transparency/Compassionate Access Lead
Using Technology to Power a Unified Global Disclosure Process
Thomas Wicks, MBA
Citeline, United States
Head of Transparency Operations
Using Technology to Power a Unified Global Disclosure Process
Christopher Dedels
Virtify, Inc, United States
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