Filing faster
with 100%
traceability.
Accelerate regulatory submissions and clinical trial reviews. Turn thousands of disparate PDFs into a unified, searchable intelligence layer for your medical and regulatory teams.
Clinical Study Report
Protocol: #PT-2024-OX
Automated Data Verification:
Verification Complete
All CSR metrics validated against Listing 16.2.7 and Listing 16.2.8.
Clinical data is complex. Reviewing it shouldn't be.
Don't let manual cross-referencing delay your time to market. Use AI that cites its sources.
❌ The Old Way: Manual "Fishing"
Data Silos
Clinical data is buried in thousands of PDFs, lab reports, and CRFs. Key safety signals are hard to spot.
Manual CSR Review
Medical writers spend weeks cross-referencing tables and listings for Clinical Study Reports.
Audit Anxiety
Preparing for FDA/EMA audits involves manual "fishing" for source documents to prove traceability.
✓ With Briefly Docs
Unified Data Layer
Drop entire trial folders into Briefly. We index every table, listing, and narrative with OCR.
Auto-Verification
Verify summary results against raw source and listing data instantly. Link directly to the row.
Instant Traceability
Generate 100% traceable audit trails. Click any metric to see the exact paragraph it came from.
Compliance metrics for leaders.
Reduction in manual CSR and CMC data verification time.
Every claim in your submission links back to raw source data.
Instant retrieval of source docs during regulatory inspections.
Ready for the audit?
Empower your clinical and regulatory teams with citation-backed document intelligence.