Pharmacovigilance Intelligence

Medicines Are Global.
Understanding Them Isn't.

Every major regulator sees only part of the picture. Cortexa connects pharmacovigilance systems across countries to reveal signals, patterns, and evidence that isolated national systems cannot see.

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The Problem

The Data Exists.
The Intelligence Doesn't.

The world already built the databases. The FDA built FAERS. The EMA built EudraVigilance. Japan built JADER. Brazil built VigiMed.

Yet drug-safety evidence remains fragmented across borders. Clinical trials are global. Medicines are global. Evidence is still local.

  • A signal in Japan takes years to reach regulators elsewhere
  • Population differences create divergent benefit-risk profiles invisible in single-country data
  • Spontaneous reporting biases differ systematically between countries
  • No shared methodology for cross-national signal triangulation exists in practice
By the Numbers
4
Countries Integrated
60M+
Safety Records
20+
Years of Documented Regulatory Divergence
1
Unified OMOP Environment
When Systems Don't Talk

Cases Where Fragmented Evidence Delayed Action

VIOXX · 2004
Cardiovascular Risk — Divergent Regulatory Timelines
Australia and European regulators acted on cardiovascular risk signals. The FDA continued deliberating. The drug remained on the market for years after early signals emerged from spontaneous reporting systems.
PANDEMRIX · 2009–2011
Narcolepsy Signal — Nordic Detection, Late Confirmation
Scandinavia detected an association between Pandemrix and narcolepsy in children. The signal was invisible to systems looking only at their own national data. Cross-national analysis confirmed it; most countries acted years later.
NAION · ONGOING
Vision Loss — GLP-1 Signal Under Active Review
Denmark detected a pharmacovigilance signal for non-arteritic anterior ischemic optic neuropathy with GLP-1 agonists. EMA is actively reviewing. The FDA position continues to differ. A cross-national PRR analysis surfaces what no single database can resolve.

These are historical examples of fragmented evidence. Not Cortexa case studies.

What Cortexa Does

A Single Intelligence Layer Across Multiple Regulatory Systems

Data Sources
FAERS · USA
VigiMed · Brazil
CVARD · Canada
JADER · Japan
→
Infrastructure
OMOP CDM
PRR Engine
→
Intelligence
Cross-National Signals
Comparative Cohorts
Regulatory Evidence

Every query returns PRR, confidence interval, and the exact denominator. No pre-computed values. No black boxes. Auditable methodology built for regulatory and litigation standards.

Built For Decisions
Pharma
Signal Validation Across Jurisdictions
Cross-national signal methodology and evidence generation. Know what other regulatory systems see before they act.
Litigation
Regulatory and Epidemiological Intelligence
Documented evidence of regulatory divergence across countries and timelines. Reproducible methodology for expert review.
Research
Comparative Population-Level Analysis
Real-world evidence from four regulatory systems in a single OMOP environment. Reproducible queries with full methodological transparency.
Why Now

Regulatory Expectations Are Increasing.

FDA Sentinel Initiative
Active surveillance infrastructure mandated post-FDAAA. Regulators increasingly expect proactive signal detection, not passive reporting.
EMA DARWIN EU
European distributed network for real-world evidence. The infrastructure for cross-national analysis is being built by regulators themselves.
EMA Regulation 2025/1466
New pharmacovigilance obligations under the updated EU framework require more systematic evidence generation and cross-border signal coordination.
Active GLP-1 Litigation
Ongoing litigation involving semaglutide and tirzepatide requires reproducible, jurisdiction-comparative pharmacovigilance evidence.
Research & Credibility

Work Anchored in the Research Community

OHDSI Vocabulary Workgroup
OHDSI Pharmacoepidemiology Workgroup
Springer Nature Review
USPTO Patent Filing In Progress
DeepInvent Credits Awarded
Fiocruz Collaboration Initiated
Who Built This

"Built by one founder. 18 months. Four countries integrated. Research, infrastructure and methodology built from the ground up."

The World Already Built The Databases.
We're Building The Intelligence Layer.

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