FDA-Aligned Document Generation
From Protocol to Submission-Ready Documents.
Generate ICF, DMP, and SAP documents directly from your trial protocol. Verifiable extraction, full regulatory alignment, 21 CFR Part 11 audit logging.
Why Choose TraceScribe?
Built for sponsors, CROs, and clinical operations teams working under FDA, ICH, and EMA frameworks.
Regulatory Document Drafting
Generate patient-ready ICFs, DMPs, and SAPs from your trial protocol. Built for sponsors and CROs.
FDA & Regulatory Compliance
21 CFR Part 11 ready. Full audit trails, version control, and verifiable accuracy for every submission.
Analytics & Data Tools
Beyond documents. Track query status, reconcile data, and visualize top-line results in one integrated dashboard.
Start drafting against your protocol.
Sponsors and CROs generate submission-ready documents with full audit logging.
Get Started