SDTM & ADaM Programming
SDTM & ADaM Programming at SRIVK Pharma Ltd. SDTM provides a standardized framework for organizing and formatting clinical data, ensuring efficiency in collection, management, analysis, and reporting. At SRIVK Pharma Ltd., our SDTM implementation benefits the biopharmaceutical industry by:
- Enabling data aggregation and warehousing.
- Supporting data mining and reuse.
- Facilitating data sharing and due diligence.
- Enhancing regulatory review and approval processes.
Our SDTM support services extend to non-clinical data (SEND), medical devices, and pharmacogenomics/genetics studies. Since SDTM is a mandatory standard for FDA (U.S.) and PMDA (Japan) submissions, we ensure compliance with global regulatory requirements while handling critical and sensitive data with expertise.