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Session 4 Track 3: Digital Drivers: Reinventing and Accelerating Clinical Trials
Session Chair(s)
Ellen Reilly, MBA
Vice President, DocuSign, United States
This session will show how technology has advanced to address critical problems in clinical trial site on-boarding and recruitment while meeting heightened expectations from an empowered patient population. Discuss the challenges for using Electronic Signature for patient consent forms and clinical trials documentation. Identify best practices around mobility, language and governance around adoption of electronic signatures, and clinical trials documentation in the cloud. Explain the regulatory and audit requirements, record retention, and adoption issues globally in moving to fully digital solution.
Learning Objective : Discuss the challenges for using Electronic Signature for patient consent forms, clinical trials documentation. Identify best practices around mobility, language and governance around adoption of electronic signatures and clinical trials documentation in the cloud. Explain the regulatory and audit requirements, record retention and adoption issues globally in moving to fully digital solution
Speaker(s)
Elizabeth McLellan
Director of Compliance and Quality, Suvoda, United States
Digital Technology IT Compliance Considerations
Beth Robinson
Executive Director, Clinical Compliance and Operations, Horizon Pharma, United States
Signature Bottlenecks in Clinical Trials
Jenny Lester, MPH
Research Manager, Samuel Oschin Comprehensive Cancer Institute, United States
Maximizing Clinical Trials Through e-Signatures
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