CDISC is the standard for submitting clinical data to Regulatory Agencies. As a member of the CDISC organization, SCiAN maintains up-to-date knowledge on SDTM implementation guidelines.
Our SDTM services include developing SDTM datasets for ongoing studies or converting legacy databases to SDTM standards.
SCiAN utilizes the industry standards/references when creating SDTM datasets:
CDISC SDTM Implementation Guide
CDISC SDTM guidance
SDTM Controlled Terminology
Indication-specific SDTM specifications, if applicable
Our processes in SDTM development are as follows:
Map raw data variables to SDTM domains (identify domains, required, expected, permissible and relationship variables)