CriterionyxInsights
Pharmacovigilance · Drug Safety
Pharmacovigilance Data & Signal Analysis
Comprehensive signal detection and regulatory communication. We synthesize complex safety data into clear, high-level reports and evidence-based guidance for decision-makers - improving risk management, informing regulatory submissions, and optimizing clinical strategies.
Disproportionality analysis · FAERS
3 SIGNALS
How we read it
Separating true safety signals from background noise.
Every drug–event pair is scored by reporting frequency and disproportionality. Pairs that cross the statistical threshold are surfaced for review - proactively, before they become headlines.
Illustrative - sample analysis shown to demonstrate methodology, not client data.
Actionable insights, clear reporting
From spontaneous reports to defensible safety decisions.
What we do
- Adverse event signal detection and trend analysis
- Risk-benefit assessment and safety profiling of medicinal products
- Aggregate report generation (PSURs, DSURs) and regulatory submission support
- Evaluation of risk minimization measures and pharmacovigilance systems
- Data integration from spontaneous reports (e.g. FAERS), EHR, and clinical trials
Our approach
- Statistical analysis using R, SAS, or similar tools for safety data
- Integration of multi-source data such as VigiBase, FAERS, and clinical trial results
- Application of pharmacovigilance methods grounded in real-world practice
- Clear communication of safety findings for both technical and non-technical audiences
Outcomes we deliver
- Identification of emerging safety signals and trends for proactive risk management
- Evidence to support regulatory submissions, labeling changes, and product defense
- Clear, defensible insights for aggregate reports, publications, and leadership briefings
- Enhanced patient safety and optimized benefit-risk profiles for pharmaceutical products
Have a safety dataset that needs a second set of eyes?
Tell us what you're monitoring. We'll show you how an evidence-based signal analysis would approach it.