We understand the process

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Dr. Stacy R. Smith has served as a consultant to many drug and device manufacturers.  His work has included development of scales to assess new endpoints, overall development programs as well as interaction with FDA before and during the review and approval process.  Thus, Dr. Smith and his staff understand the development and approval process.  To some sites, the regulations and requirements seem onerous; at CDCRI we know that they are a necessary part of an overall scheme.

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