All products
Signal detection — periodic review
Product X · review period Q2 2026 · sources: safety database + literature
SignalAssessment
Hepatic enzyme elevation / Product X
PRR 2.8 · 95% CI 1.9–4.1 · 12 cases
Under validation
Statistical signal detected
Renal events in 65+ cohort
ROR 3.1 · 95% CI 2.2–4.4 · increasing trend
Trend confirmed
Clinical context requested
Dizziness / Product X
No disproportionality · literature conflict reviewed
No validated signal
Medical review closed
Every signal carries its data source, calculation method, review rationale and decision. · Illustrative product experience.
How the work moves, end to end.
- What enters
- Aggregate reports, drug-event pairs, safety-database feeds, literature escalations and periodic reporting datasets.
- What is assessed
- Statistical screening, trend analysis, disproportionality detection and drug-event pair review with clinical and epidemiological context.
- What action follows
- Signal validation, signal assessment, regulatory handoff and integration with the QPPV oversight view.
- What evidence remains
- Data source, calculation method, period under review, review rationale, signal decision and regulatory action record.
What it does.
- Aggregate report intake
- Safety-database integration
- Drug-event pair analysis
- Statistical screening
- Disproportionality detection
- Trend analysis
- Signal validation
- Signal assessment
- Regulatory handoff
- QPPV oversight integration
- Structured export
Next layer
COMPLIVISE Regulatory
From regulatory change to measurable organizational impact.