A sponsor-owned governance model that turns an existing bot ecosystem into controlled, human-reviewed clinical monitoring oversight — and a working product that proves the model runs.
VigilNova is risk-based monitoring made continuous: every site watched in real time, risks surfaced before they turn critical, and a clean trail of who reviewed what.
▶ Pitch · 1:18
The goal isn't to replace monitors or clinical judgment. It's to govern, calibrate, and scale bots so they surface the right risks, route the right issues, and leave inspection-ready evidence of sponsor oversight — across FSPs, sites, studies, and implementation teams.
Bots accelerate signal detection, but outputs need intended use, QC, change control, and human review.
Outsourced monitoring works best when the sponsor can see quality, risk, and escalation status in near real time.
Engineers can build fast, but risk logic, evidence standards, and escalation criteria must be clinically led.
Bots flag, summarize, route, and draft. Humans own significance, final decisions, escalation, and accountable documentation.
This keeps automation fast while preserving sponsor oversight, clinical judgment, auditability, and compliance defensibility.
The full operating model, 90-day build plan, priority workflows, and the metrics leadership should see — with clear lines of accountability for what was detected, reviewed, decided, and closed.
Regulatory footing — FDA risk-based monitoring guidance · ICH E6(R3) GCP · 21 CFR 312.52 sponsor/CRO transfer of obligations.
Download the PDF ↓VigilNova is a risk-based monitoring platform I designed and built — the model above, running. This is the full guided walkthrough, screen by screen.
▶ Full walkthrough · 8:22