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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)
Digital Technology IT Compliance Considerations
Elizabeth McLellan
Suvoda, United States
Director of Compliance and Quality
Signature Bottlenecks in Clinical Trials
Beth Robinson
Horizon Pharma, United States
Executive Director, Clinical Compliance and Operations
Maximizing Clinical Trials Through e-Signatures
Jenny Lester, MPH
Samuel Oschin Comprehensive Cancer Institute, United States
Research Manager