Verisian builds a cloud-native platform that automates the validation and documentation required for clinical trial submissions. The system uses deep learning and AI to validate SDTM and ADaM analyses - the standardized data formats used in pharmaceutical and medical device regulatory filings - and generates submission documentation compliant with FDA, PMPA, and NMPA requirements. By automating these processes, the platform replaces traditional double-programming validation methods with AI-powered analysis and full study traceability.
The platform integrates with existing infrastructure via simple file transfer, enabling organisations to deploy it quickly without extensive system overhaul. Verisian positions this approach as accelerating time-to-market for new medicines and devices whilst improving the quality and transparency of submissions to regulatory authorities. The company serves pharmaceutical companies, medical device manufacturers, and clinical research organisations across the United States, Japan, and China.
