As understood, SDTM provides a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting. By implementing SDTM, SCL IT achieves for bio-pharma industry the benefits of,
- Provides data aggregation and warehousing
- Fosters mining and reuse
- Facilitates sharing and helps perform due diligence
- Improves the regulatory review and approval process
Our SDTM support services are provided to non-clinical data (SEND), medical devices and pharmacogenomics / genetics studies. SDTM is one of the required standards for data submission to FDA (U.S.) and PMDA (Japan). We understand the vital and sensitive aspects of SDTM for the global biopharmaceutical industry.