The New Gold Standard: Pfizer's Quality by Design Approach to Trial Management
By Dan Ressler and Amy Cheung
Improving the quality of clinical trials has emerged as a major strategic activity for Big Pharma, one where efficient management of a demanding set of regulatory requirements - not to mention mounting clinical and patient expectations - can have a positive impact on the bottom line. In the following "leading practices" feature, Pfizer outlines how it has employed a management tool first introduced in the automotive sector to enhance its ability to process reams of data from clinical trials to raise the quality of trial submissions, improve regulatory compliance and avoid costly rework that ultimately impacts speed to market performance for new drugs.
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Posted with permission from the April 2013 issue of Pharmaceutical Executive ® www.PharmExec.com.
Copyright 2013, Advanstar Communications Inc. All rights reserved.