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Bethesda North Marriott Hotel and Conference Center

Feb 06, 2017 7:00 AM - Feb 08, 2017 5:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

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

Elizabeth McLellan

Director of Compliance and Quality, Suvoda, United States

Digital Technology IT Compliance Considerations

Beth  Robinson

Beth Robinson

Executive Director, Clinical Compliance and Operations, Horizon Pharma, United States

Signature Bottlenecks in Clinical Trials

Jenny  Lester, MPH

Jenny Lester, MPH

Research Manager, Samuel Oschin Comprehensive Cancer Institute, United States

Maximizing Clinical Trials Through e-Signatures

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