Data Management CDISC

Clinical Data Interchange Standards Consortium – Study Data Tabulation Model (CDISC-SDTM)
Regulatory submission according to CDISC standards is greatly required owing to the FDA preference for such submission of clinical trial data. Our CDISC - SDTM standard libraries are built into our clinical data management applications to make data conversion relatively simple. Additionally, we have the skills required for smooth transition of data into regulatory compliant formats.

 

We have an expert team of professionals with sound knowledge in these standard structures, corresponding implementation guides, CDISC terminologies and the related ICH guidelines.

 

Based on a well-developed plan, the statistical analysis implementation provides clients with timely, high-quality deliverables.

 

CDISC Services:

  • Legacy data conversion
  • Implementation support
  • Compliance checks
  • Training
  • SDTM implementation roadmap
  • CDISC, eCRF Datasets, Define.XML, Define.PDF
  • FDA data reviewers’ guide
  • SDTM compliance report
  • ADaM