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Integrations

The three global adverse event databases your PV obligations run on — connected.

TrialVyx ingests directly from FDA FAERS, EudraVigilance, and VigiBase/WHO UMC, and exports MedDRA-coded signal output into your existing safety management system.

3 regulatory data sources connected
< 4 hrs typical integration setup
REST API for programmatic access

Regulatory Data Sources

Three global safety databases, unified

FDA FAERS

US adverse event reporting system. Consumer, healthcare professional, and manufacturer submissions since 1990. The primary US post-market safety surveillance database.

Reports 20M+
Coverage US market since 1990
Update Quarterly (FDA release)

EudraVigilance

EMA's pharmacovigilance database covering suspected adverse reactions for human medicines authorized in the EEA. Accessible data includes publicly reported ICSRs.

Reports 30M+
Coverage EU/EEA market
Update Continuous (EMA)

VigiBase / WHO UMC

Global ICSR database maintained by the Uppsala Monitoring Centre on behalf of WHO. Reports from 130 countries via national pharmacovigilance centers.

Reports 30M+ ICSRs
Coverage 130 countries global
Update Monthly (WHO UMC)

Safety System Connectors

Output connectors for your existing PV systems

TrialVyx signal output exports into safety management systems your team already uses.

Destination system

Oracle Argus Safety

Signal briefs exported via REST API in structured JSON format, compatible with Oracle Argus Safety's case intake workflow. Signal ID, drug information, and MedDRA coding pre-populated.

Method REST export
Format JSON / XML
Destination system

Veeva Vault Safety

Structured XML export compatible with Veeva Vault Safety's signal management workflow. Audit trail data included in export for Vault's compliance documentation.

Method Structured XML
Format XML / CSV
Destination system

Velaris Safety Suite

Signal intelligence feed via API connector. Real-time signal alert delivery for Enterprise Safety tier customers. Signal triage queue integration available.

Method API connector
Format JSON feed
Universal export

CSV / Excel / JSON API

Standard export formats for teams using in-house systems or custom pharmacovigilance infrastructure. JSON API for programmatic signal data access.

Method Download / API
Format CSV, XLSX, JSON

Developer API

REST API for programmatic signal access

Direct integration for custom PV infrastructure or internal data warehouses.

GET /v1/signals List signals with filters
GET /v1/signals/{id}/evidence Signal evidence + ICSRs
GET /v1/portfolio/monitoring Portfolio signal status
POST /v1/signals/{id}/triage Record triage decision
Auth API key — header Authorization: Bearer {key}
Rate limit 1,000 req/hr (Portfolio Monitor); unlimited (Enterprise)
Versioning API v1 stable — breaking changes on major version only
JSON response — GET /v1/signals 
{
  "signals": [
    {
      "id": "TVX-SIG-2025-04817",
      "drug_combination": [
        "atorvastatin",
        "cyclosporine",
        "omeprazole"
      ],
      "ae_pt_code": "10037781",
      "ae_pt_term": "QT prolongation",
      "ic_score": 2.47,
      "tier": "INVESTIGATE",
      "trend_pct_90d": 18.3,
      "detected_at": "2025-04-03",
      "meddra_smq": "Cardiac arrhythmias",
      "contributing_icsrs": 47
    }
  ],
  "total": 12,
  "page": 1
}

API documentation available to active customers. Contact us for integration planning.

Integration setup: under 4 hours with your PV team.

We configure FAERS/EudraVigilance ingestion and safety system export settings directly with your PV and IT teams. Most setups complete in a single working session — we handle the data source connections, your team validates the compound list and export format.

Start Integration Setup Platform Overview

Questions about your stack? [email protected]