戻る Agenda
Session 4 Track 3 - Technology Enablers to Optimize EDM
Session Chair(s)
Michelle L. Charles, MPH
Director, Regulatory Affairs, Gene Therapy Program
University of Pennsylvania, Perelman School of Medicine, United States
Advances in technology have enabled the industry to continuously innovate in the creation, management, and integrity of data and documents. This session will present a variety of technology developments and offer the impact and benefit of each advance. Beginning with electronic and digital signatures incorporated into document approvals and workflows, the session builds with sharing the advances needed to enable the collaborative processes between consortiums, business partners, and sponsors with disparate systems. The final presentation will bring it all together with an overview on the impact and benefit of the adoption of an eTMF on a Clinical Data Management group. Get insight on how implementing cutting edge technology along with adopting efficient technology enablers into business processes can to lead to improved resource utilization, efficient business processes, enhanced integrity, and compliance.
Learning Objective : Describe eTMF (electronic Trial Master File) implementation within major Pharma Company Clinical Data Management. Discuss Best Practices, usage of eTMF reference model, tool used and limitations encountered, Global implementation considerations. Highlight Efficiencies gained, business process development considerations. Ultimate vision of the project from business perspective.
Speaker(s)
Managing Trust, Identity, and Security in Digital Transactions
Ellen Reilly, MBA
DocuSign, United States
Vice President
Facilitating Collaborations Through Technology
Elisa Cascade, MBA
Advarra, United States
Chief Product Officer
eTMF for Clinical Data Management
Ajitha Gadangi, MS
Merck & Co., Inc., United States
Associate Director