From clinical study reports to eCTD submissions and pharmacovigilance case processing — AI extraction built for the document complexity of regulated pharmaceutical R&D.
Clinical, regulatory, quality, and safety documents all processed through a single AI layer with domain-specific validation rules per document type.
| Document Type | Examples | What AI Extracts |
|---|---|---|
| Clinical Study Reports | ICH E3 CSRSynopsesProtocol Amendments | Primary/secondary endpoints, adverse events table, patient demographics, statistical analysis plan compliance, exposure data |
| Regulatory Submissions | CTD Module 2–5eCTDCommon Technical Document | Module-wise completeness check, cross-reference validation, summary table extraction, missing section flagging |
| Safety Reports | PSUR/PBRERDSURSUSAR Reports | Cumulative exposure, case narrative extraction, signal detection keywords, MedDRA term mapping, CIOMS form data |
| CMC Documents | Drug Master FilesStability ReportsSpecifications | Test method parameters, specification limits, batch analysis data, excipient details, manufacturing site data |
| Pharmacovigilance | ICSR / MedWatchE2B(R3)Argus/ARISg feeds | Case seriousness, causality assessment, reporter information, product details, patient narrative with temporal relationships |
| Quality System Docs | SOPsDeviationsCAPA reports | Root cause classification, effectiveness check status, deviation severity, corrective action ownership, closure criteria |
From raw document ingestion to submission-ready structured data — audit trail maintained at every step.
Extract endpoint data, adverse event tables, and patient baseline characteristics from CSRs and case report forms. Reduce manual medical writing support effort by 60–70%.
Automate CTD/eCTD module population from source study documents. Cross-reference validation catches inconsistencies across modules before submission.
Process incoming ICSRs from literature, patient reports, and clinical trials. Extract E2B(R3) fields, assess seriousness and expectedness, and route to Argus or ARISg.
Parse stability study reports, compare against registered specifications, and flag out-of-specification results for investigation before batch release.
Convert paper-based and scanned clinical archives into searchable, structured data. Useful for lifecycle management, label updates, and regulatory enquiry response.
Map source documents to FDA, EMA, CDSCO, and TGA requirements simultaneously. Flag region-specific gaps without duplicating manual review effort.
Built to operate inside GxP-validated environments with full audit trail support.
Enterprise engagements. Source code and validation documentation yours on project close.
3–4 week fixed scope
8–16 weeks. All document types.
FDA + EMA + MOHAP scope
The system processes Clinical Study Reports (CSR/ICH E3), CTD Module 2–5 and eCTD submission packages, Periodic Safety Update Reports (PSUR/PBRER), CMC (Chemistry, Manufacturing and Controls) documents, Individual Case Safety Reports (ICSR/MedWatch), Drug Master Files (DMF), Investigator Brochures, and regulatory correspondence (FDA, EMA, CDSCO). Both native electronic documents and scanned legacy archives are supported.
Yes. The system supports 21 CFR Part 11 requirements for electronic records and signatures: full audit trails on every document access and extraction action, role-based user authentication, and data integrity checks. On-premise deployment is available so regulated GxP data never leaves your validated infrastructure. GAMP 5 validation documentation (IQ/OQ/PQ protocols) can be provided as part of the delivery.
Yes. The system handles both native electronic documents (PDF/Word/XML) and scanned or photographed documents including older case report forms, hand-annotated lab notebooks, and legacy regulatory correspondence. OCR accuracy for structured pharma forms exceeds 93% on clean scans; the system flags low-confidence fields for human review rather than silently passing incorrect data downstream.
Proof of concept on your document types: 3–4 weeks. Production build: 8–16 weeks depending on integration depth (CTMS, RIM, safety databases like Argus or ARISg). GxP validation documentation (IQ/OQ/PQ) adds 4–6 weeks. Most clients see full ROI within 6–9 months through reduced manual abstraction time and faster regulatory submission cycles.
Book a 30-minute call. Bring 2–3 real document samples and we'll show extraction accuracy before any contract is signed.