One platform for modern pharmacovigilance.
Signal Automation and Literature Monitoring in one governed workspace — reviewer-controlled, automated where it counts, audit-ready by design.
Put the pharmacovigilance busywork on autopilot.
Vigicore automates the mechanical steps end to end — intake, coding, scoring, drafting, and the audit trail — so your reviewers spend their time on judgment, not data wrangling.
Multi-channel intake
Case data, PubMed, journals and dictionaries flow in on a schedule — no inbox triage, no manual uploads.
MedDRA coding
Reactions auto-coded to PT and rolled up to SOC from the shared, version-stamped dictionary.
Disproportionality at scale
PRR, ROR, EBGM and IC computed across every drug–event pair — every run, automatically.
Deterministic triage
Explainable scoring surfaces the literature that matters and lets the noise fall away.
E2B(R3) drafting
Qualifying cases assembled into structured, submission-ready draft packages.
Continuous audit trail
Intake, coding, calculations, decisions and sign-off are written to an append-only trail as they happen.
Automated where it's mechanical — reviewer-controlled where it counts. Vigicore never draws automatic causality conclusions.
Two apps. One identity, one dictionary, one audit trail.
Purpose-built apps on shared foundations — so teams move between detection, evidence, literature, and documentation without losing control.
One sign-in
A single, MFA-protected OnePV identity opens every app. One account, one session across the suite.
One MedDRA dictionary
A shared, version-stamped MedDRA dictionary powers coding and SOC roll-up consistently across all apps.
Tenant-scoped & role-based
Multi-client operating model with role-based access — built for MAHs, CROs, and PV service providers.
One audit trail
Human-readable, append-only audit history across detection, review, and documentation.
Signal Automation
Disproportionality detection, evidence review, a persistent signal register, and Signal Evaluation Report drafting — under reviewer control.
- ▹ PRR · ROR · EBGM · IC scoring
- ▹ MedDRA hierarchy & SMQ grouping
- ▹ Signal lifecycle register
- ▹ Guardian-assisted SER drafting
Literature Monitoring
Consolidated PubMed and journal surveillance with deterministic, explainable triage and structured ICSR / E2B(R3) drafting support.
- ▹ PubMed + local journal scanning
- ▹ Deterministic, self-learning triage
- ▹ MedDRA coding (PT / SOC)
- ▹ ICSR / E2B(R3) drafting support
See the workspace your reviewers work in.
Structured capture, transparent analysis, a qualified-reviewer gate, and a permanent, inspectable record — the same governed flow across both apps.
Capture
Case data, literature, and the shared MedDRA dictionary land in one governed workspace.
Analyze
Disproportionality and deterministic triage surface what needs attention — transparently.
Reviewer control
Every flagged item is gated by a qualified reviewer. No automatic causality, no black box.
Audit-ready record
Decisions, evidence, and rationale persist in an append-only history, ready for inspection.
Built for control, traceability, and trust.
Vigicore is designed for reviewer-facing transparency — not black-box conclusions.
Reviewer-controlled
Decisions stay with people. Vigicore surfaces evidence and structure — it does not draw automatic causality conclusions.
Validated calculation logic
Transparent, documented statistical methods aligned to recognised disproportionality approaches.
Audit-ready by design
Traceable, append-only history so every step of the review can be reconstructed.
Human-in-the-loop
Designed around the reviewer journey — from output to interpretation to documentation to sign-off.
Enterprise multi-tenant
Role-based access and per-client isolation for portfolios and repeated data cuts.
Evidence-bound Guardian
Drafting support is tied to gathered evidence and stays under reviewer control.
Designed to fit how PV teams work across major and regional authorities — automating MedDRA coding, E2B(R3) drafting support, and audit-ready records, with reviewers in control of every decision.
Request a demo, a pilot, or an investment conversation.
Tell us about your team, portfolio, or partnership interest and we'll follow up with the right next step — a guided walkthrough, a scoped pilot, or a founder conversation.
Signal Automation and Literature Monitoring are live and growing. We're seeking strategic investment and enterprise partnerships to scale OnePV.
Read the investment story →