SDTM

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