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That Awkward Stage: Transition from Paper Trial Master File to eTMF
Program Code:
131
Date:
Monday, June 24, 2013
Time:
2:30 PM to 4:00 PM
EST
CHAIR
:
Denise Derenzo Lacey, MA,MS (SCHNON), Principal Consultant, Halloran Consulting Group, United States
SPEAKER
(S):
Stacy Hitchman,
(SPKNON), Associate Director, Global Clinical Operations,
Biogen Idec, United States
14+ yrs of Clinical Drug Development experience. Stacy held a series of progressive positions where she drove clinical dev. strategy and execution and was a key contributor to the dev. of 3 products, an FDA BIMO Inspection, and now is appointed to define best practices for clinical documentation.
|
Sharon Ames,
(SPKNON), Enterprise Program Director,
NextDocs Corporation, United States
Ms. Ames offers over 25 years of clinical experience, with over 10 years in the CRO industry and 15 years clinical site experience. Prior to joining NextDocs Ms. Ames was the Global Director, Trial Master File management for INC Research.
|
Krystyna Kowalczyk, (SPKNON), Executive Vice President, Clinical Operations, Novella Clinical, United States
Description
In this session, we will explore best practices for making the transition from a paper to electronic trial master file (TMF), from the different perspectives of an eTMF vendor, a clinical operations sponsor, and an electronic document management system manager.