Connecting the Pharmacovigilance Ecosystem with Confidence and Compliance

Clinical System Integrations

• EDC Platforms (e.g., Medidata Rave, Veeva EDC, Oracle InForm) for AE/SAE case intake during clinical trials
• CTMS (e.g., Oracle Siebel CTMS, Veeva CTMS) for real-time access to study and site information

Regulatory Systems

• RIM Systems (e.g., Veeva Vault RIM, Ennov, ArisGlobal) to streamline product registration and labeling updates
• eCTD Tools for electronic submissions

Regulatory Authority Gateways

• Full support for E2B (R3) gateway submissions to:
  • EMA (EV Gateway)
  • FDA ESG
  • PMDA Gateway
  • Health Canada and other global authorities

Signal & Risk Management Tools

• Integration with Empirica Signal, Qlik/Spotfire dashboards, and other tools for signal detection and risk analysis

Medical Information & Complaint Systems

• SCIMAX MI, Salesforce, TrackWise, SAP QM integrations for MI and product quality complaints

Literature & Intake Automation

• Connections with Embase, PubMed, and literature automation tools for case intake from global scientific sources
• AI/ML-enabled automation for email and document-based case capture

ERP, MDM, and Quality Systems

• Integration with SAP, Oracle Fusion, and MDM platforms for consistent product and license data
• Links with QMS and DMS platforms (e.g., Veeva Vault, MasterControl) for documentation and compliance tracking