What Is SDTM?
The Clinical Data Interchange Standards Consortium’s (CDISC) Study Data Tabulation Model (SDTM) provides a standardized format for organizing clinical trial data, ensuring consistency, quality, and interoperability.
The FDA and PMDA expect CDISC-compliant datasets at submission. Waiting too long for SDTM implementation can put you at risk of:
Data flagged as incomplete or inconsistent
Queries unresolved after site closure
Analyses based on flawed or truncated datasets
At IDDI, we master CDISC SDTM standards to meticulously prepare your data for submission.
Uncompromising Excellence in SDTM and Data Standards Implementation
As a CDISC Registered Provider with experience handling SDTM in more than 100 studies, IDDI offers excellence in CDISC SDTM compliance, efficiently developing eCRFs to CDASH standards and delivering data in SDTM format.
Our SDTM and data standards implementation services include:
- Mapping to SDTM standards
- Annotated SDTM CRFs
- Define.xml and define.pdf files
- Validation of data and define.xml files
- Clinical data reviewer’s guide (cSDRG)
- Integrated summaries of safety & efficacy (ISS/ISE)
- Dataset conversion specification files
- And more
Our SDTM and data standards implementation services are also grounded in close collaboration with our biostatistics teams to ensure alignment with downstream analysis and:
- Support progressive, biostatistics-oriented data cleaning
- Reduce rework and delays
- Enable earlier site closure
- Lower risk of inaccurate results
Simplify Your Journey to Submission
Navigating the complexities of SDTM compliance and data standards implementation becomes easy with IDDI by your side.
