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CDISC is ‘a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata.

The aim of CDISC is to ensure that data from clinical trials is submitted in a clear, consistent and standardized format that allows

accurate, logical conclusions to be drawn for regulatory approval to be attained. Regulatory submission according to CDISC standards is greatly required owing to the FDA preference for such submission of clinical trial data.

Our CDISC - SDTM standard libraries are built into our CDM applications, making conversion of data relatively simple.  Additionally, PPCE personnel have the skills required for smooth transition of data into regulatory compliant formats.  Our expertise in various CDISC models will help save time, effort and money by increasing efficiency through standardized data and reducing the time taken to gain regulatory approval.

Contact us for more information on PPCE’s CDISC services.