Safety data reaches your vendor two ways: an SAE worksheet dropped in the central mailbox, or a case pulled out of EDC and saved to PDF. Intaqe.ai reads either source and produces the same compliant, E2B(R3)-ready output — mapped straight into Argus or Veeva.
The SAE worksheet from the central mailbox, or the case exported from EDC — via API, email connector, or direct upload.
LLM + SLM extraction with MedDRA and WHODrug candidate coding, seriousness assessment, expectedness against your loaded RSI, and the 7- or 15-day clock — every field confidence-scored.
Reviewers see source and extraction side by side. One click jumps from any field to its evidence. Judgment calls — causality, expectedness — are flagged, not faked.
Validated XML imports directly into Oracle Argus, Veeva Vault Safety, or any E2B-compliant system.
Per ICH guidance, a valid case requires four elements. Intaqe identifies each, grounds it to its exact location in the source, and flags exactly what is missing when a report is incomplete.
Initials, age, sex, or identifier — located and linked to the source span.
Product, dose, and regimen, auto-coded against WHODrug.
HCP or consumer, with qualification captured for causality context.
Verbatim term preserved, MedDRA-coded, seriousness assessed per ICH E2D.
Most intake tools stop at typing the data for you. Intaqe ingests the study's Reference Safety Information and, for each event, checks the reported term against the listed expected reactions — with the matching reference line shown as evidence.
The extracted term is matched against the loaded RSI, per product, with the listing (or its absence) quoted as evidence.
A more severe, more specific term is not assumed covered by a broader listing — the subtle call that drives real expedited decisions.
Compound events are split into component terms and each assessed separately, so an unexpected component is never buried.
Intaqe proposes expectedness with evidence and a confidence score. The binding determination stays with your CRO or sponsor reviewers.
Late expedited reports are among the most damaging PV inspection findings. Intaqe assesses each case against the FDA IND safety reporting framework and surfaces the clock before a human has even opened the file.
Serious, unexpected, drug-related events that are fatal or life-threatening — flagged immediately for the 7-calendar-day report.
Other serious, unexpected, related cases — surfaced with the 15-calendar-day deadline and days remaining.
Expectedness and causality drive the clock and require human determination. Intaqe proposes; the qualified reviewer confirms.
The sponsor awareness date is captured at first receipt, so the clock starts when it should.
Intaqe is built on a simple rule: the AI proposes, a qualified human disposes. Every output is traceable from source document to submitted case.
Every data point links to a page and position in the source. Inspectors verify any field in one click.
Immutable audit trails, electronic signatures, and alignment with GVP Module VI expectations.
Pre-built IQ/OQ/PQ documentation and per-release performance reports for your CSV files.
A 30-minute walkthrough with your (de-identified) source files.
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