Intaqe does book-in, triage, case entry and Initial Medical Review against your preloaded RSI — then a simple QC by your CRO or sponsor.
Adverse-event volumes climb 10–15% a year while safety budgets stay flat. For biotech and pharma, book-in, triage, entry, medical review and QC — all by hand, on every case and every follow-up — consume the majority of the PV budget and run against a non-negotiable reporting clock.
Book-in, triage, case entry and Initial Medical Review take a team of people and days. Intaqe does all four against your preloaded RSI — then a simple QC by your CRO or sponsor.
No book-in queue. No manual entry. No full QC. Just a simple QC of the E2B fields — in under a minute.
Large language models read the source. Small, specialized models extract, code and assess. A deterministic regulatory layer enforces E2B(R3), MedDRA/WHODrug and the seriousness & RSI rules. Paired with our proprietary data-ingestion system, that cuts case-processing cost 60–70% — with regulatory-grade, schema-valid output.
Source documents arrive in dozens of languages. Traditional intake ships them to a translation vendor first — days gone before processing even starts, against a 7- or 15-day clock. Intaqe translates in-model the moment a case lands, keeps the original for the record, and processes immediately.
Traditional intake software captures the document and routes it — every downstream task still lands on a person. Intaqe does the work and hands your CRO or sponsor a finished, QC-ready case to verify.
Industry-reported per-case processing ranges; per-case saving is an illustrative target pending validation.
Load the study Reference Safety Information once. Intaqe makes a medical-grade first call on reportability on every case, with the evidence shown — so your CRO or sponsor simply confirms, at a fraction of the cost.
INITIAL MEDICAL REVIEW · PRELOADED RSI · < 1 MINEvery field arrives populated, grounded to its source, and confidence-scored. Your CRO or sponsor reviews the E2B fields and signs off — a simple QC, not a re-keying.
A regulated pipeline: every stage logged, every artifact versioned, every action attributable — on a foundation your IT and quality teams already trust.
GxP-aligned, validated, and access-controlled from day one — so adopting Intaqe doesn't open a compliance gap.
Single sign-on via Okta, SAML or OIDC. SCIM provisioning, MFA and your identity policies — no separate logins to manage.
Immutable audit trails and electronic signatures on every action, attributable to a named user.
GAMP 5 / CSA-aligned with IQ/OQ/PQ evidence for your CSV file. GCP and GVP Module VI aligned.
Encryption in transit and at rest, regional data residency (GDPR), tenant isolation, and zero-retention LLM terms — your data never trains a model.
Least-privilege RBAC with full user and action traceability across the portal.
Every case stamped with model, prompt and dictionary version — reproducible for inspection.
Every field grounded to its source · 21 CFR Part 11 · GVP-aligned · Human-verified, every time
A 30-minute walkthrough with your (de-identified) worksheet or EDC export — processed live.
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