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Program Code:
335
Date:
Wednesday, June 26, 2013
Time:
10:15 AM to 11:45 AM
EST
CHAIR
:
Jonathan Seltzer,
MD,MA,MBA,FACC (SCHNON), President and CEO,
Applied Clinical Intelligence, LLC, United States
Dr. Seltzer is an expert the establishment and operation of independent expert endpoint committees and DMCs. He is CEO of ACI, whose iCommittees unit provides these services to industry and non-profit organizations. Additionally, he is active in the CSRC and CTTI efforts to improve clinical trials.
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SPEAKER
(S):
Douglas Burgener,
(SPKNON), Product Manager, EDC and Virtual Clinical Adjudication System (VCAS),
Perceptive Informatics, United States
I have worked in the clinical trial technology industry for more than 10 years, focusing on study design, standards, and data capture. I am currently in product management with responsibilities for advancement of EDC and Adjudication technologies.
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Debra Montgomery,
MSN,RN (SPKNON), eCRF Librarian, CDS III,
Duke Clinical Research Institute, United States
Deb Montgomery, RN, MSN has been involved in Clinical Research for 15 years, nine of which were working with Clinical Endpoint Adjudication. Her endpoint work involved studies ranging from Phase I – IV and pharmaceutical and device trials, with an emphasis on events in Cardiac Mega Trials.
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Nicole Pushlar, (SPKNON), Clinical Scientist, Clinical Trial Management, Boehringer Ingelheim Pharmaceuticals, Inc., United States
Description
CRO, sponsor, and agency perspectives on the evolution of clinical endpoint adjudication committees (EACs) will elucidate relevant definitions and emerging requirements substantiated by case studies and metrics from dozens of global programs/projects.