Everything you need to accelerate your regulatory processes
End-to-end CSR automation with complete traceability and compliance
Input your Clinical Protocol and Statistical Analysis Plan. Instantly draft all non-data sections within seconds.
Post data lock-in, perform automatic biostatistical analysis and generate Tables, Listings, and Figures.
TLF outputs are converted into data-centric sections, completing the full document with end-to-end traceability.
Search and interpret the latest regulations specific to your drug or medical device with instant answers
Search across FDA guidance documents, regulations, and requirements with AI-powered interpretation.
Access international harmonization guidelines and standards for comprehensive compliance.
Access PSG documents for bioequivalence and formulation recommendations tailored to your products.
Get immediate, contextual responses from FDA and ICH sources with citation tracking and source verification.
Word-level traceability from source data through final CSR document ensures audit-ready compliance.
Eliminate manual work with intelligent automation that learns from your protocols and standards.
Bank-level encryption, SOC 2 compliance, and role-based access control for your sensitive data.