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Implementation of Adaptive Clinical Trials
Program Code:
371
Date:
Wednesday, June 27, 2012
Time:
1:30 PM to 3:00 PM
EST
CHAIR
:
Jim Box, Aptiv Solutions, United States
PRESENTER
(S):
Mary Riggs, Aptiv Solutions
Dr. Vlad Dragalin is a world-leading expert in adaptive trial design and execution. Dr. Dragalin has over 25 years experience in developing the statistical methodology of adaptive designs, and over 12 years experience in the pharmaceutical industry including positions at GSK, Wyeth, and Quintiles.
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Description
Although adaptive design concepts have been available for some time, only recently has implementation been achievable. This breakthrough is possible because of the development of integrated technologies and operational processes specifically designed to support the execution of adaptive trials.
Brought to you by Aptiv Solutions.
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Learning Objectives:
Discuss validated adaptive design software solutions available today
Identify importance of integrated technologies designed specifically to manage interim analysis steps
Describe AptivAdvantage™, an integrated EDC/Randomization, drug supply and adaptive design engine Discuss the requirements for adaptive trial specific SOPs, processes, and work practices.