SDTM

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