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Transforming Culture and Mindsets to Deliver a Higher Quality eTMF

Track:
Processes and Technologies for Clinical Research

Day & Time:
June 17, 3:30PM - 5:00PM (Pacific Standard Time)

Session Number:
290

Room Number:
33AB

Level:
Intermediate

Type:
Session

Title:
Transforming Culture and Mindsets to Deliver a Higher Quality eTMF

Chair(s):
Bryan Ennis
Director, R&D Customer Success
Veeva Systems, United States

Description:
This session will provide best practices that can be used to leverage technology and drive cultural and mindset changes to increase the quality and value of the electronic trial master file (eTMF). Cutting-edge survey results will be presented on industry drivers and barriers to a paperless eTMF, lined up with proven best practices, and demonstrated by a sponsor case study.


Learning Objective(s):
Describe drivers and barriers to removing paper in processes connected to your eTMF; Explain how eTMF technology can change protocol design, trial management, lower costs, and improve efficiency; Recognize how new eTMF technologies are influencing the interactions between sponsors, investigators, and CROs; Identify necessary change management activities to transform legacy processes.

Presentation(s) & Speaker(s):
What Is Keeping Us From a Paperless TMF: Survey Results
Bryan Ennis
Director, R&D Customer Success
Veeva Systems, United States

Five Factors to Consider to Maximize External Use of an eTMF System
Michael Agard, MS
Principal Consultant
Paragon Solutions, United States

Transforming Clinical Processes to Make the Most of the eTMF: Case Study
Renee Fate
Senior Manager, Document Management
Kythera Biopharmaceuticals, Inc., United States