Pharmacovigilance
in one click.

Enter a drug name. Get a complete safety signal profile — adverse events, time-to-onset, and demographic risk — sourced from 1.3 million published case reports, with source citations to back it up.

No account needed. Data from published case reports in the medical literature.

1.3M+Case Reportsfrom 1952–2026
23M+Clinical Eventsacross 125K patients
10K+Adverse Reactionswith causality evidence
<1sQuery Responsemedian response time
Interactive Platform

One click.
Complete signal profile.

What used to take a pharmacovigilance team weeks to compile now surfaces in a single query. Run a search to see an empirical, literature-backed safety profile instantly.

rxQuery
Quick:
Methodology

Statistical signal detection from thefull published literature.

rxQuery applies established disproportionality analysis methods across 1.3 million published case reports — not just spontaneous reporting databases. Every signal is grounded in documented patient outcomes with traceable source citations.

Proportional Reporting Ratio (PRR)

Primary

Measures how often an adverse event occurs with a drug versus all other drugs. PRR ≥ 2 with N ≥ 3 triggers signal review, adapted from WHO-UMC criteria.

Reporting Odds Ratio (ROR)

Case-control analog for secondary confirmation. Lower bound of 95% CI > 1.0 required for signal elevation, adapted from EMA GVP Module IX.

Signal Classification
CriticalPRR ≥ 5 • Immediate action
PRR 5+
MajorPRR 2–5 • Labeling review
PRR 2–5
ModeratePRR 1–2 • Monitoring
PRR 1–2
Noise / LowPRR < 1 • None detected
< 1

Thresholds adapted from WHO-UMC guidance and EMA GVP Module IX recommendations for literature-based signal detection.

Capabilities

Everything your safety team needs.

Adverse Event Profiling

A ranked, quantified view of every reported event.

Each adverse event is paired with event frequency, severity classification, time-to-onset distribution, and PRR-weighted signal strength.

StructuredEvent Classification
CitedSource Publications
PRR-WeightedSignal Strength
Pembrolizumab — Top SignalsPRR 3.8
Immune-mediated Colitis
18.2%major
Autoimmune Thyroiditis
12.7%moderate
Hepatotoxicity (Grade 2+)
8.4%major
Pneumonitis
5.1%critical
Adrenal Insufficiency
3.8%moderate

Time-to-Onset Patterns

Understand when adverse events typically emerge after drug initiation, enabling proactive monitoring at the right time points.

ColitisWk 4–6
ThyroiditisWk 8–12
HepatotoxicityWk 6–10
PneumonitisWk 3–8
Adrenal InsufficiencyWk 12–20

Bar = median onset relative to treatment duration

Risk Stratification

Who is most at risk, and when.

Events stratified by sex and age bracket from actual patient profiles in the published literature — not modelled estimates.

F: 57%Pembro. colitis
55–69Peak age bracket
Regulatory Export

Export directly to submission format.

One-click export of structured signal reports in E2B(R3) XML pre-fill format or CSV for further analysis.

E2B(R3) XML pre-fill for submission workflows
PSUR / PBRER appendix tables
Structured CSV export
Real-Time Database Sample

Top compounds by adverse event case volume.

Derived directly from 1.3M published case reports.
Click any highlighted compound to run a live signal profile in the interactive demo above.

Critical (PRR ≥ 5)
Major (PRR 2–5)
Moderate (PRR 1–2)
CyclophosphamideCrit
987
CarbamazepineMaj
843
ValproateMod
689
IbuprofenMod
612
ClozapineMaj
578
InfliximabMod
534

Case counts derived from published literature case reports. Signal levels correspond to the highest PRR threshold detected for that compound.

Regulatory Alignment

Built around the frameworks regulators require.

Every signal generated by rxQuery is structured to align with international pharmacovigilance standards, reducing the manual burden on your regulatory affairs team and simplifying preparation for submission.

EMA & FDA Compatible

Signals formatted to support submission workflows via E2B(R3) individual case safety report pre-fill.

GVP Module IX Aligned

Signal management workflow designed around EMA GVP Module IX principles for detection, evaluation, and prioritisation.

Structured Throughout

All adverse events structured and categorized for compatibility with standard pharmacovigilance terminology systems.

E2B(R3) Pre-fillICSR XML for submission workflows
GVP Module IXSignal management workflow
CSV ExportStructured data for further analysis
REST APIProgrammatic signal access

Regulatory frameworks supported: EMA and FDA submission workflows.

Solutions

Designed for the teams managing drug safety.

Hours saved per drug review40+
Signal profiling that required a team now surfaces in seconds.

From manual literature trawl to instant signal intelligence.

Your pharmacovigilance scientists currently spend days searching PubMed for adverse event evidence. rxQuery aggregates that evidence continuously, structures it, and surfaces it in one click.

  • Continuous signal detection across 1.3M published case reports.
  • Pre-built PSUR/PBRER appendix tables ready for submission.
  • Literature-sourced signals with full citation traceability.
Enterprise Deployment

Fits into your existing safety workflow.

Accessible via secure web portal or integrated directly into your safety database through the REST API.

Secure by Design

Encrypted in transit and at rest. No patient data leaves your environment.

Safety Database Integration

REST API connects with your existing safety database via authenticated endpoints with full audit logging.

Literature-Based Monitoring

Signal analysis based on published case reports with full citation traceability.

Part of the Query Family
rxQuery
CaseQuery

rxQuery is the pharmacovigilance layer built on the same 1.3M case report database that powers CaseQuery. Same source. One optimised for safety signals — the other for clinical diagnosis and treatment intelligence.

Explore CaseQuery

Ready to see your drug's safety profile?

Schedule a 20-minute demo. We'll run a live pharmacovigilance signal report for any compound in your portfolio — right in front of you.