At Intego Clinical, we’ve helped countless partners become CDISC compliant and map legacy data into SDTM and ADaM formats. Our talented clinical data professionals can map all major data formats onto the appropriate CDISC standards. We are able to assist pharmaceutical companies with all aspects of data migration and compliance: from mapping strategies and developing internal standards to the creation and submission of regulatory documents.
The Clinical Data Interchange Standards Consortium (CDISC) is a non-profit organization that manages global industry data standards for clinical data analysis, reporting and regulatory submission. For pharmaceutical companies pursuing regulatory approval from the FDA and PMDA, all regulatory documents must meet CDISC standards to avoid submission delays.
We handle the conversion of internal data standards to Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM) and define.xml formats. Our clinical data professionals also work with TLFs, and all other clinical data formats.
Intego Clinical is a thought leader in CDISC mapping and compliance. We have full access to new CDISC documentation and the latest industry standards. Thanks to this in-house expertise we develop customized mapping strategies based on client data needs, and advise on company-wide data integration and conversion procedures.
At Intego Clinical we have helped countless partners become CDISC compliant. We handle large and small mapping projects, working with all common clinical data formats. Our rigorous internal QC on mapped datasets has helped us become the trusted partner of pharma and biotech companies around the globe.