CDISC (Clinical Data Interchange Standards Consortium) develops globally recognized data standards that improve the quality, efficiency, and cost-effectiveness of clinical trials by making data easier to share, understand, and analyze.
We offer end-to-end consulting—from data collection and mapping to CDISC domains, defining supplemental variables, to submission-ready datasets aligned with regulatory expectations like FDA and PMDA.
We support all major CDISC models including SDTM (Study Data Tabulation Model), ADaM (Analysis Data Model), CDASH (Clinical Data Acquisition Standards Harmonization), and Define-XML, along with implementation of Therapeutic Area Standards (TAUGs).
Absolutely. We specialize in retrospective mapping and legacy data conversion, transforming your existing data into compliant CDISC formats, ready for submission or reuse.
Yes, TechyVignan provides custom CDISC training sessions—from foundational knowledge to advanced implementation—tailored to your project needs and team expertise.