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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Feedback

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Like Stephen Covey said  “Start with the end in mind”.  We understand what a sponsor wants to see at the end of a study and what they DON’T want to see.  We keep an eye our for problems DURING the trial and will let you know if we see something.  We will let you know early on so adjustments can be made rather than waiting to the end and finding out there was a problem that now cannot be fixed.

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It’s all about the data

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Understanding primary endpoints and making sure we get that data – Subjects may miss a visit or be late for a visit for abroad variety of reasons, some good, so not so good.  A subject out of window or missing that primary endpoint visit means all their data is for naught for that per protocol analysis.  We work diligently to keep subjects in window for all visits but especially for the primary efficacy endpoint visit.

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