ICSR to E2B in one tool, with the QPPV gates intact.
Intake spontaneous, literature, trial, and E2B(R3) inbound cases. Let AI suggest MedDRA coding and draft ICH E2D narratives. Your QPPV gates every step with e-signature. Output E2B(R3) XML ready for gateway submission.
The case lifecycle — with the right gates
Status transitions enforced in the state machine. Reviewer + QPPV e-signatures required at medical review + submission gates. Every AI suggestion requires a qualified human to confirm before moving forward.
What the platform does
Drop an XML file from a partner / licensor and Praxara creates the case with seriousness + patient + reporter + product fields mapped.
Gemini 3.1 Pro returns PT / LLT / SOC for your verbatim. Clearly marked 'AI suggestion — qualified coder must verify'. Works with licensed MedDRA dictionary when installed.
Generates a compliant case narrative: patient background, event, causality assessment, outcome. Reviewer approves with e-signature — AI never exports.
Detects life-threatening / hospitalisation / medically important from the verbatim and flags the 15-day expedited clock.
Aggregates cases over a period, drafts each ICH E2C(R2) section, explicitly notes limitations when data is sparse.
Due-by deadlines calculated from receipt date + seriousness. Overdue highlighted in queue. Notifications to QPPV.
How the AI stays safe for PV
- Every MedDRA code tagged "AI suggestion — requires qualified coder verification". Never finalised automatically.
- Narrative drafts carry explicit caveats and limitations; the human signer takes responsibility.
- When data volume is too low for signal claims (<3 cases), PSUR drafts say so in plain English.
- Full audit trail: which model, which version, prompt hash, reviewer, reason code, signature timestamp.
- MedDRA dictionary integration ready — licensed from MSSO, plugged in as a validator.
See it against your own documents.
20-minute demo. Bring a redacted CSR, PSMF, or ICSR. We'll run it live end-to-end.