The FDA has issued a guidance recommendation for submitting clinical trial data by using the Standard Data Tabulation Model (SDTM) format developed by the Clinical Data Interchange Standards Consortium (CDISC). TechnoSTAT provides full CDISC-compliant services.
Standard clinical trials require two forms of submitted datasets:
Study Data Tabulation Model (SDTM), the standardize data structure for clinical data collected, and Analysis Dataset Model (ADaM), which present derived data used for data analysis.
TechnoSTAT’s skilled, experienced DM team can satisfactorily support you with transforming legacy data to CDISC-compliant format.
Our Services Include:
- Preparation of complete SDTM and ADaM databases for submission
- Preparation of CDISC-compliant metadata (define.xml)
- Mapping of original non-CDISC-compliant data to standardized terminology and structure, including SDTM annotated case report form (aCRF)
- CDISC compliant statistical services