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CROs: Filling the Resource Gap


Posted by mddiadmin on September 1, 2004


Originally Published MX September/October 2004

BUSINESS PLANNING & TECHNOLOGY DEVELOPMENT


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Trials and Tribulations

With the burgeoning complexity of regulatory and clinical data requirements for combination products involving drugs and devices, full-service clinical research organizations (CROs) are being called upon to play an increasingly active role in product development programs.

CRO regulatory personnel are typically involved in many product development programs, and are therefore broadly familiar with global regulations as well as unwritten expectations. More importantly, these regulatory specialists have often observed firsthand which strategies have been successful and which have failed, making them well qualified to guide device and drug development teams to the best choices for their programs.


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