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The product

One case, from messy intake to filed E2B.

Follow a single adverse-event case through Quorum. The AI assembles it; your team reviews every field against its source; the audit trail records who did what, and when.

01 · INTAKE

Intake from any format.

Adverse-event reports arrive as email, PDF, scanned fax, structured XML, or a call-center transcript. Quorum ingests all of them and starts a case — no manual re-keying.

  • · Email, PDF, scanned image, E2B XML, transcript
  • · Batch import for backlogs and migrations
  • · Source documents kept and linked to the case
SOURCES · 4
PDFfax_report.pdfp.1–2
EMLreporter_followup.eml2 KB
TXTcall_transcript.txt6 min
XMLpartner_e2b.xmlE2B(R3)
MEDDRA 28.1 · SUGGESTED CODING
Rash maculo-papular98% ✓
PT 10037868 · Skin disorders
Pyrexia95% ✓
PT 10037660 · General disorders
Malaise71% · review
PT 10025482 · General disorders
02 · AI PROCESSING

MedDRA coding, with confidence.

The AI extracts data, codes symptoms to MedDRA preferred terms, assesses seriousness and expectedness, and drafts the clinical narrative — each suggestion carrying a confidence indicator so reviewers know where to look first.

03 · Human review — the difference

Click any value. See exactly where it came from.

This is the single most differentiating thing Quorum does. Every AI-generated field is click-to-source: select a value and the exact sentence, document, and page that produced it appear beside it. The reviewer is still the one who decides — they just stop retyping and start checking.

· Provenance on every extracted field and code
· Reviewer queue with seriousness and due-date triage
· Edits and approvals recorded to the audit trail
EVENT (MEDDRA PT) · click-to-source
Rash maculo-papular
fax_report.pdf · p.1
…two days after starting therapy, developed a maculo-papular rash across the trunk…
AI proposes · humans commit
04 · NARRATIVE

Narrative generation, on your template.

A drafted clinical narrative in your house style, built from the reviewed fields — every clause traceable to source, editable inline before approval.

05 · SUBMISSION

E2B(R3) export, gateway-ready.

Generate a validated E2B(R3) file for the receiving regulator, with the full transmission and acknowledgement history retained on the case.

Audit & inspection

This is the screen an FDA inspector sees.

A complete, immutable who / what / when trail for every case — including which model version produced each AI suggestion, and who approved it.

EVENTACTORMODEL / SOURCETIMESTAMP
MedDRA PT codedAI suggestionqm-coder-4.216 Jul 09:14
Field approvedA. Kachinthayahuman16 Jul 10:02
E2B(R3) generatedA. Kachinthayaexport16 Jul 10:05

Clinical-stage or commercial — one system.

Clinical-stage

Trial safety reporting with the deadlines and formats regulators expect.

SAEserious adverse event
SUSARsuspected unexpected serious adverse reaction
DSURdevelopment safety update report
Commercial-stage

Post-market case processing and aggregate reporting at volume.

ICSRindividual case safety report
PBRERperiodic benefit-risk evaluation report
Aggregatesignal and periodic reporting

See it on your case.

Bring a real, de-identified case. We'll process it end-to-end in 30 minutes.