A Guide to CDISC Standards Used in the Clinical Research Process

22nd September 2020

The Clinical Data Interchange Standards Consortium is an organisation dedicated to helping to improve medical research by driving communication through data standardisation. This data standardisation enables the rapid design, build, analysis, and submission of clinical trials.

CDISC and the FDA have worked closely to allow regulatory reviewers to process and review clinical trials more effectively. The FDA now requires studies to be submitted using “standardised data”. These standards make it easier for a regulator to understand and process clinical trial data.

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