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Driving Toward Standardization: Overcoming Barriers - eDM, eTMF, and CTMS

Processes and Technologies for Clinical Research

Day & Time:
June 16, 11:00AM - 12:30PM (Pacific Standard Time)

Session Number:

Room Number:



Driving Toward Standardization: Overcoming Barriers - eDM, eTMF, and CTMS

Betsy Fallen, RN
Site Ready Lead, Global Clinical Trial Operations
Merck & Co., Inc., United States

Significant resources (people, technology, funding) have been allocated by industry across several critical technologies required to support an overwhelming amount of data/document flows through today’s modern biological/pharmaceutical/device industry. While the transition from paper to electronic systems remains a work in progress the need for standardization has never been greater. Well-formed, pragmatic standards for data transfer and document management processes can drive efficiencies and encourage faster progress. This is especially pertinent in the current industry context where organizations fall in a matrix of just starting to implement electronic trial master file (eTMF), electronic document management system (EDMS), clinical trial management system (CTMS) to advanced implementations. This symposium, a critical starting point to three dialogues on EDM, eTMF, investigator portal and CTMS, provides an introduction and real-world critique of these systems.

Learning Objective(s):
Define each technology and diffusion status; Describe efficiencies realized through each technology; Highlight success stories based on collaborative approaches to the development of standards; Identify the continued challenges regarding full integration for a seamless life cycle of essential inspection and regulatory documentation.

Presentation(s) & Speaker(s):
eTMF/EDM/eCTD: The Whole Shebang
Adair Turner
Director, Regulatory and Clinical Operations
Mission3, Inc., United States

The Complicated Life of a (TMF) eSubmission Document
Lisa D. Mulcahy
Owner, Principal Consultant
Mulcahy Consulting, LLC, United States

Integrating Across Pharmaceutical Company CTMS Systems to Generate a Uniform Data Structure
Graeme Benson, PhD
Chief Information Officer
Drugdev.org, United Kingdom