Navitas Life Sciences

CDISC SDTM Conversion, a Case Study in Perfection

This case study discusses the conversion of raw datasets to Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (SDTM) format and Define XML including reviewers guide for a global, tier one pharmaceutical company. It documents the conversion strategy, challenges faced, and process based conversion approach which facilitated highly complex studies conversion.

This ongoing multi-year project involves conversion of raw data from multiple therapeutic areas into CDISC SDTM standards and creating submission ready documents.

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