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Regulatory Submissions, Information, and Document Management Forum


Session 4 Track 3: Digital Drivers: Reinventing and Accelerating Clinical Trials

Session Chair(s)

Ellen  Reilly, MBA

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

Digital Technology IT Compliance Considerations

Elizabeth McLellan

  • Director of Compliance and Quality
  • Suvoda, United States
Beth  Robinson

Signature Bottlenecks in Clinical Trials

Beth Robinson

  • Executive Director, Clinical Compliance and Operations
  • Horizon Pharma, United States
Jenny  Lester, MPH

Maximizing Clinical Trials Through e-Signatures

Jenny Lester, MPH

  • Research Manager
  • Samuel Oschin Comprehensive Cancer Institute, United States