Responsive WordPress Theme

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Metro Design Style

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Nullam id dolor id nibh ultricies vehicula ut id elit. Etiam porta sem malesuada magna mollis euismod. Vivamus sagittis lacus vel augue laoreet rutrum faucibus dolor auctor. Praesent commodo cursus magna, vel scelerisque nisl consectetur et. Cras mattis consectetur purus sit amet fermentum. Cras justo odio, ...

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Optimize WordPress

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Nullam id dolor id nibh ultricies vehicula ut id elit. Etiam porta sem malesuada magna mollis euismod. Vivamus sagittis lacus vel augue laoreet rutrum faucibus dolor auctor. Praesent commodo cursus magna, vel scelerisque nisl consectetur et. Cras mattis consectetur purus sit amet fermentum. Cras justo odio, ...

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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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Not qualified subjects…. GOOD subjects

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Many potential subjects just meet the enrollment criteria but may be otherwise may be poor candidates. Their disease is really not that severe, they are not really motivated to participate in a study or they may have already demonstrated that they are unreliable.  We look ahead to imagine how a subject may perform in a study and consider whether they are a GOOD subject for this study.

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