The Smart Data Blog

Dan Kesack

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With CDISC Adoption by FDA, Managing Clinical Trial Metadata with Semantic Technology Has Emerged Front and Center!

Posted by Dan Kesack on Dec 4, 2014 4:44:00 PM

As FDA outlines, “the submission of standardized study data enhances a reviewer’s ability to more fully understand and characterize the efficacy and safety of a medical product,” and adopted CDISC standards based on semantic technology to be the standards for submitting and using study data. They further “envision a semantically interoperable and sustainable submission environment that serves both regulated clinical research and health care.”

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Topics: CDISC, Metadata, Semantics, Data Management, Clincal Trials