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.
As you start planning your regulatory submission for the FDA or PMDA, you should consider implementing standard data collection tools to meet the expectations of the regulatory agency for standardized data in your submission. You may be required to convert data for legacy studies.
We will help you determine the “ideal” approach for your regulatory submission, outlining the risks and benefits to differing strategies. If you have a data standards implementation strategy in place, our experts can help you execute your data conversions.