From signal detection to Signal Evaluation Report — under reviewer control.
A controlled workspace that takes pharmacovigilance teams from disproportionality output to interpretation, evidence, and documentation. The statistics are transparent; the conclusions remain with qualified reviewers.
Intake → Detect → Review → Document.
Intake
Upload a data cut; map columns once into a controlled, validated structure.
Detect
The engine computes frequentist and Bayesian disproportionality across drug–event combinations.
Review
Triage flagged DECs with MedDRA context, subgroup views, and gathered evidence.
Document
Track signals in the register and draft an audit-ready Signal Evaluation Report — reviewer-signed.
Everything a signal review needs, in one place.
Disproportionality engine
Case-based PRR, ROR, Yates χ², 95% lower bounds, and Bayesian EBGM / IC scoring — transparent and documented.
MedDRA hierarchy & SMQs
PT → HLT → HLGT → SOC roll-up and Standardised MedDRA Query grouping for clinically meaningful aggregation.
Controlled data intake
Guided column mapping and validated intake so every run is structured, comparable, and repeatable.
Subgroup & stratified review
Disproportionality across subgroups with masking-aware comparisons that respect the data.
Persistent signal register
A cross-run register tracks each signal through its lifecycle — detected → validated → assessed → closed, with due dates.
Evidence review
FAERS / openFDA, EU evidence, and literature validation gathered right beside the signal under review.
Run comparison & trends
Compare historical runs and watch re-signalling and trend movement across repeated data cuts.
Guardian-assisted SER
Evidence-bound drafting support for Signal Evaluation Reports — the reviewer controls every conclusion.
See Signal Automation on your data.
Request a guided walkthrough or a scoped pilot with your own data cut, and we'll show how detection, review, and SER drafting come together.
Signal Automation and Literature Monitoring are live and growing. We're seeking strategic investment and enterprise partnerships to scale OnePV.
Read the investment story →