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

We make it Professional - contact us

Address: 17 Metsada Street, 12th Floor , Bnei Brak, 5120118. Israel

Tel: +972-9-7669333 

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