CDISC Data Standards Implementation - Services

CDISC data standards specify how to structure clinical trial data for regulatory submissions to the US Food & Drug Administration (FDA) and the Japan Pharmaceutical and Medical Devices Agency (PMDA). These standards are now required for data collected in all phases of clinical research.

With our experience and ability to stay up to date with current technologies we can help your company make data standards implementation and migration seamless, even though it can be a complicated process.

Clinical Trial Data Standards Conversion

What is SDTM and Why is So Important?

One of the many challenges facing sponsors is preparing their clinical trial data for submission to the U.S. FDA. This is because the FDA requires all clinical trial data to be in Study Data Tabulation Model (SDTM) format – such standardization greatly speeds up their review process.

Veristat is an active member of the Clinical Data Interchange Standards Consortium (CDISC) and an approved Registered Solutions Provider. We currently follow STDMIG 3.1.3 to STDMIG 3.2 and ADaMIG 1.0. As an industry leader we continuously discuss trends and changes to the implementation guidelines with CDISC to ensure we stay up-to-date with CDISC standards as they come available.