From R&D Dark Matter
to Audit-Ready Intelligence

Clinical trial files, batch records, SOPs, and lab notes exist as static PDFs, scans, and handwritten forms. Senior scientists spend up to 30% of their time manually locating and re-keying data that already exists somewhere in your document estate.

Cloud-based AI services require your compound data, patient narratives, and formulation specifics to leave your perimeter. A single breach or vendor policy change can expose multi-billion dollar pipeline IP. “Rented AI” is an existential risk in pharma.

Semantic inconsistencies across eCTD modules — caught only at FDA/EMA review — result in months of delays and direct financial penalties. Manual cross-checking across thousand-page dossiers is error-prone and chronically understaffed.

As your document volumes grow — more trials, more markets, more products — your processing costs grow proportionally. You pay more precisely when your business is most active. This is a structural misalignment that owned infrastructure eliminates.

Handwritten batch records, scanned lab notebooks, eCTD PDFs, CRFs, CSRs — any format, any quality, any language.

Radon, Xenon, and Krypton models — specifically trained on pharma document types — extract with clinical precision.

AI agents perform cross-document consistency checks: eCTD module cross-referencing, TMF reconciliation, MEDDRA coding.

Validated data feeds directly into your QMS, ERP, TMF, or regulatory submission platform via API or structured file.

Every extraction linked to source bounding box. Every agentic decision logged. Always audit-ready for 21 CFR Part 11.

Trained on technical cursive, low-quality scans, and degraded originals. Reads batch records signed by laboratory technicians with the same precision as typed documents. The model that unlocks your “dark matter.”

Understands clinical intent within patient narratives, physician notes, and safety reports. Extracts adverse event signals, suspect drugs, and clinical symptoms — then cross-references MedDRA codes automatically.

Identifies table structure and spatial relationships within CMC dossiers, Certificates of Analysis, and regulatory filings. Maps extracted data to your internal taxonomy automatically.

Autonomous agents monitor TMF repositories (Veeva, SharePoint) in real time, performing semantic reconciliation against study protocol. “Always audit-ready” status — no manual TMF review cycles.

Cross-document consistency checks across all five eCTD modules before submission. Catches the semantic inconsistencies that cause Refusal to File — before you submit to FDA or EMA.

Xenon extracts patient data, suspect drugs, and clinical symptoms from adverse event reports. Cross-references MedDRA codes and auto-populates ICSR fields with 95%+ accuracy.

Technical cursive models digitise complex tables and signatures in batch records. Extracts specs, test results, and deviation records from CoAs for GMP compliance tracking.

Agents categorise quality events, identify deviation trends across your QMS, and draft initial CAPA investigation reports. Transforms reactive quality management into proactive oversight.

Digitises and semantically indexes decades of lab notes, allowing researchers to query compound interaction history across your entire R&D archive. Unlocks the “dark matter” of your pipeline.

Extracts GxP obligations and audit rights from vendor contracts. Flags non-conformances, tracks CAPAs, and mitigates third-party risk across your supply chain.

Extracts insights from field visit reports, KOL interaction records, and medical inquiry responses. Surfaces patterns across your medical affairs activity that would otherwise remain siloed.

Every Intics deployment is tuned to your specific document types, taxonomy, and downstream systems. Book a Dark Matter Discovery session to map your document estate.

Your IP leaves the firewall on every call

Per-page fees scale with your pipeline success

Vendor policy risk on data handling

No institutional learning — model doesn’t improve on your data

Fully sovereign — data never leaves your perimeter

Fixed infrastructure — near-zero marginal cost per document

CapEx ownership — capitalise as an infrastructure asset

Continuous learning on your document estate

Full technical controls for electronic records and signatures: system-generated audit trails, user authentication and access controls, timestamped versioning, and immutable record storage. Every extraction is linked to its source document bounding box — providing the evidentiary chain an FDA auditor requires.

Intics is designed for the rigour of Good Clinical, Manufacturing, and Laboratory Practices. Agentic decisions are logged with full “chain of thought” reasoning for regulatory review. Human-in-the-loop review is built into the workflow for every flagged edge case — not retrofitted.

Intics supports fully sovereign, air-gapped installations for the most sensitive R&D environments. Patient PII is masked at the point of ingestion via field-level data protection. No patient data, compound data, or formulation specifics leave your defined perimeter — contractually and architecturally.

Intics processes and validates documents across 50+ regulatory jurisdictions — FDA, EMA, CDSCO, PMDA, and beyond. Regulatory intelligence agents monitor guidance updates across all active jurisdictions and trigger labelling reviews when changes affect your approved indications.