Clinical studies are a vital component of development and regulatory approval of veterinary medicines for the global marketplace. In contrast to research-phase studies, which may provide a “reasonable expectation” of safety and efficacy, clinical studies for regulatory submission must “establish” safety and efficacy.  This is accomplished in large part through valid study design, documented in a comprehensive protocol.  Generation of a high-quality protocol, however, is just one aspect of meeting the stringent regulatory requirements for establishment of product safety and efficacy.  Lindsey Edwards from Triveritas talks us through many aspects of clinical study conduct and explains how to control and manage clinical studies properly.

 

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