Pharmacovigilance Signal Intelligence
Pre-computed safety signal intelligence across adverse events, labels, outcomes, REMS, and historical label changes.
The problem this solves
Life sciences teams need decisions faster than public data can be cleaned manually. This solution compresses months of preparation into a governed, query-ready product.
VP-level and director-level teams often know which questions matter, but the required data is spread across incompatible FDA, CMS, NIH, EMA, USPTO, literature, ontology, and identity sources.
Pharmacovigilance Signal Intelligence removes the repeated engineering work by delivering the connected tables, bridge keys, and sample queries that your team would otherwise build from scratch.
What you get
Normalized FAERS case, drug, reaction, indication, outcome, therapy, and report-source tables.
Drug-reaction PRR scores pre-computed by quarter and enriched with seriousness and outcome fields.
Label coverage detection against active and historical FDA labels to flag potentially unlabeled signals.
Safety burden context from REMS programs and label-change chronology.
Context Layers Powering This Solution
Each card links to a query-ready context layer in the biomedical estate.
Post-market adverse-event signals and safety reporting context
Regulatory layer • 25M+ reports • Quarterly
Safety & Pharmacovigilance contextReporter, patient, and case-demographic safety context
Safety & Pharmacovigilance layer • 25M+ cases • Quarterly
Safety & Pharmacovigilance contextDrug-event disproportionality and label-coverage context
Safety & Pharmacovigilance layer • 60M+ drug-reaction pairs • Quarterly
Regulatory contextCurrent prescribing context, warnings, indications, and dosing
Regulatory layer • 54K+ active labels • Weekly
Regulatory contextLabel-change history and regulatory event timeline
Regulatory layer • 140K+ versions • Monthly
Regulatory contextRisk-management requirements and safety-burden context
Regulatory layer • 400+ programs • Monthly
Scientific contextDrug-target mechanism and bioactivity context
Scientific layer • 2.5M compounds • Quarterly
Day-one query results for adalimumab
Designed sample output showing the type of redacted table your analysts can query immediately after provisioning.
| Signal | Value | Source |
|---|---|---|
| Canonical entity | adalimumab | Drug spine |
| Primary risk score | High confidence | Pre-computed model |
| Connected products | 7 products | TDD catalog |
| Latest refresh | 2026-09-01 | Lineage table |
Built for the teams who own the decision
For Pharmacovigilance teams
Prioritize emerging drug-event pairs and understand whether signals are already reflected in labeling.
For Safety science teams
Connect reaction terms to outcomes, mechanisms, indications, and label history.
For Regulatory affairs teams
Track signal evidence ahead of label negotiations, REMS updates, and post-market commitments.
Common questions
Procurement, architecture, and analytics teams can evaluate exactly how the product will land in your environment.
Query on day one
Sample SQL included
Does this replace clinical safety review?
No. It eliminates data engineering and pre-computes surveillance features so safety experts can review evidence faster.
What signal method is included?
The standard package includes PRR with case counts, expected counts, seriousness filters, and label coverage. Other calculations can be added in custom delivery.
Are drug names normalized?
Yes. Messy suspect-drug strings are mapped to the drug identity spine with confidence and lineage fields.
See This Solution In Action
We'll walk through live warehouse queries and sample outputs for your specific use case.
Request Demo