SDTM (Study Data Tabulation Model)
SDTM is a standard clinical database structure whose purpose is to streamline the processing of clinical data for analysis, reporting and regulatory submission.
The SDTM database is a required standard for FDA and PMDA submissions.
Our SDTM services include:
- Building new CDISC-compliant databases according to the CDISC CDASH and SDTM standards for clinical database construction for new and legacy studies alike
- Creation of special CDISC SDTM domains for specific therapeutic areas
- Mapping of collected data to CDISC standards for integrated summaries of safety and efficacy (ISS/ISE) and FDA submission
- Compatibility with any version of the SDTM Implementation Guide
- Conversion of collected data to CDISC-compliant controlled terminology
- Construction of the CDISC “metadata” file (define.xml) that serves as the table of contents for the clinical database