For biotech & pre-launch teams
A real safety operation before your first approval.
You need compliant pharmacovigilance from first-in-human onwards — but not a six-figure enterprise system or a year of implementation. VigilantLabs is sized for where you are, and scales to where you’re going.
Fit for where you are now
Compliant from first patient
Structured ICSRIndividual Case Safety Report — the standard record of one patient’s suspected adverse reaction to a medicine. capture, MedDRAThe standard medical dictionary used to code adverse events so every company and regulator describes the same reaction the same way. coding and expedited reporting workflows from day one of your trial — not retrofitted before inspection.
No enterprise timeline
Go live in 4–6 weeks at a fixed fee. Your safety operation exists before your next ethics committee asks about it.
Right-sized commercials
Subscription tiers for lean teams and low case volumes. Try the ROI calculator with your actual numbers — it takes two minutes.
AI covers the gap
When you don’t have a ten-person PV department, AI-assisted intake and coding keep quality high without the headcount.
Grows with the pipeline
Add products, jurisdictions and users as programs advance — same platform, no re-implementation.
Investor- and partner-ready
A validated, audit-trailed safety system is due-diligence evidence for licensing deals and funding rounds.
Scope a pilot around your next milestone.
Tell us your trial timeline and case volume — we’ll propose a right-sized setup and honest pricing on the first call.
Or call +61 425 228 763 · answered in Melbourne, AEST/AEDT