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Omni Shoreham Hotel

Sep 22, 2014 8:30 AM - Sep 24, 2014 1:00 PM

2500 Calvert Street NW, , Washington, DC 20008 , USA

EDM and ERS 2014

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Session 2 Track 2 - Outlining the Pathway to a Paperless Trial

Session Chair(s)

Betsy Fallen, RN

Betsy Fallen, RN

Consultant

BAFallen Consulting LLC, United States

Through the use of a case study surrounding the successful implementation of an eTMF, the transition from a paper-based system into an eTMF & paperless study start up, the panel will give practical advice for taking on a paperless system.

Learning Objective : After attending and participating in the QA, participants will be able to recognize the importance of adopting and evolving toward a paperless study start up. Participants should also be able to identify ways they can improve their start up (or clinical trail eTMF process) via a paperless system.

Speaker(s)

Technology Review: How to Implement Paperless Clinical Trial Technology into Your Clinical Trial: Feasibility to Close Out

Shannon Cooke, MS

TransPerfect Translations, United States

Project Manager

Ron Fitzmartin, PhD, MBA

Update on eSource from a Regulators Perspective

Ron Fitzmartin, PhD, MBA

FDA, United States

Senior Informatics Advisor, Office of Regulatory Operations, CBER

Case Study: Practical Example of Running a Paperless Clinical Trial: Study Start up and eTMF Management

James Desanti

PharmaVigilant, United States

President and CEO

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