CDISC, SDTM, and ADaM Compliance

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Speed up regulatory readiness with tools designed for precision and consistency using automated data mapping and conversion for seamless CDISC workflows.

Our Services Include:

• Consulting expertise to support clients in meeting the challenges of CDISC compliance
• Transforming legacy data to CDISC-compliant formats
• Preparing NDAs with full submission-ready SEND, SDTM, and ADaM data packages in SAS transport v5 (.xpt) format
• Creating define.xml and data reviewer’s guide documents for SEND, SDTM, and ADaM data packages
• Preparing the trial summary dataset (ts.xpt) for preclinical legacy studies
• Performing consistency checks, which are beyond Pinnacle 21 validation checks, for define.xml against aCRFs and databases
• Designing clinical databases with the CDASH-compliant eCRFs