ADaM (Analysis Data Model) is designed to provide a standardized structure for analysis datasets, ensuring clear traceability from raw data (SDTM) to statistical results. It simplifies analysis, improves transparency, and supports regulatory review processes.
The FDA mandates ADaM-compliant datasets for NDA, ANDA, and certain BLA submissions to promote consistency, ease of review, and reproducibility of analysis. ADaM helps regulatory reviewers understand how results were derived from the original data.
At Techvignan, our expert programmers create ADaM datasets that fully align with CDISC standards. We ensure accurate mapping, metadata documentation, and traceability, supporting smooth submission and audit-readiness.
Yes. SDTM organizes raw clinical trial data for submission, while ADaM prepares data for analysis. ADaM datasets are derived from SDTM and are designed to support statistical computations and regulatory review of trial results.
Absolutely. We offer legacy data conversion services, transforming existing datasets into ADaM-compliant formats while preserving data integrity, ensuring compliance, and preparing your study for regulatory submission.
