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)
  • Create SDTM specification documents
  • Program SDTM domains
  • Validate SDTM domains
  • Annotate eCRF
  • Create Define.xml
  • Create Study Reviewer’s Guide
  • Produce Submission Package
  • Quality Control at each step of the process