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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
BAFallen Consulting, LLC, 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