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SynteractHCR Enhances Adaptive Trial Capabilities
Date:5/30/2013

SAN DIEGO, May 30, 2013 /PRNewswire/ -- SynteractHCR, a leading full-service global contract research organization (CRO), has completed validation and training on East®, Cytel's adaptive trial software, enhancing its consulting services on adaptive trials to its clients, especially for those smaller or emerging companies that may not have the resources to run adaptive trial simulations in-house. SynteractHCR now offers design, simulation and clinical execution services for adaptive trials.

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The adaptive trial group at SynteractHCR works under the direction of Dr. Greg Wei , director of biostatistics. An expert on biostatistics for regulatory issues, Wei has more than 20 years of pharmaceutical and statistical experience.  Wei has direct regulatory experience with the FDA and EMA, and has presented to both agencies on special protocol assessment and adaptive trial design, both of which are crucial areas for pharma and biotech companies as they are pressured to increase trial efficiency and reduce study costs.

Adaptive trial designs use accumulating data to modify trials under progress without undermining the integrity of the trials. They allow sponsors to adjust certain parameters such as dosage, subject population, or sample size in consideration of statistically significant safety or efficacy data. The goals are to accelerate clinical development and improve its efficiency, better target experimental drugs to responsive patient groups, and reduce the number of patients exposed to inappropriate or ineffective therapies. Accordin
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