Proposition 01 — Enterprise PV platform
The safety database sized for ANZ — not shrunk from somewhere else.
Case intake, regulatory workflows, auditability, safety monitoring and reporting in one cloud platform — built for sponsors, biotech, CROs and PV service teams working to TGA and Medsafe requirements.
Case processing queue
AI triage onCardivast 10mg
AU-2026-01481
Nurolex 50mg
AU-2026-01477
Pulmoclear Inhaler
NZ-2026-00293
Dermavant Cream
AU-2026-01465
MedDRA 27.1 coding · duplicate detection · audit trail on every action
Go-live, fixed fee
4–6 weeks
Includes validation documentation, dictionary setup and migration of your existing case data. You start with your cases in the system — not an empty tenant.
- Hosted in AWS Sydney
- Support in AEST/NZST
- No per-seat pricing traps
Everything a PV operation needs, in one system.
No bolt-ons for the basics — these are the capabilities your team uses every day, in the same case record.
Case intake & management
Capture ICSRIndividual Case Safety Report — the standard record of one patient’s suspected adverse reaction to a medicine.s from every channel — embedded tools, email, E2B(R3)The global electronic format regulators (TGA, Medsafe, EMA, FDA) use to receive safety reports. Think of it as the required envelope for an ICSR. gateway, literature — into structured cases with dedupe, seriousness assessment and jurisdiction clocks started on receipt.
Regulatory workflows
TGA E2B(R3)The global electronic format regulators (TGA, Medsafe, EMA, FDA) use to receive safety reports. Think of it as the required envelope for an ICSR. and Medsafe CARMCentre for Adverse Reactions Monitoring — New Zealand’s national pharmacovigilance centre, run by Medsafe. steps are native, with per-case deadline tracking. EMA and FDA pathways are ready when your program goes global.
Auditability
Every view, edit, AI suggestion and submission is hash-verified and timestamped. TGA or sponsor inspections get a one-click export, not a reconstruction project.
Safety monitoring
Continuous disproportionality screening and cluster detection across your case volume, with review queues so signals are assessed — not just alerted.
Reporting & analytics
Live dashboards for case load and compliance, PSURPeriodic Safety Update Report — a scheduled, regulator-required summary of a medicine’s worldwide safety profile. line listings, and export packs for regulators and partners — no BI tool required.
AI-assisted processing
Extraction, duplicate detection and MedDRAThe standard medical dictionary used to code adverse events so every company and regulator describes the same reaction the same way. coding suggestions on every case. A qualified person approves each step, and the audit trail records who accepted what.
See the product
The whole PV workflow, in one clean interface.
From adverse-event intake to AI-assisted signal detection and regulator-ready submissions — watch the platform work.
CASES THIS MONTH
342
ACTIVE SIGNALS
17
DUE IN 48H
6
SERIOUSNESS MIX · AU + NZ
Built for the way your team works.
Discuss a pilot with your own cases.
Bring a sample of real workflows to a 20-minute demo. We'll show the platform handling them live — and if it fits, scope a pilot with success criteria you set.
Or call +61 425 228 763 · answered in Melbourne, AEST/AEDT