Global Pharmacovigilance

Due to the experience of our team and the breadth of databases that they have worked with in their previous roles in Pharmaceutical companies, we have the ability to work with your database. 

In-house we utilise several different databases to support different client needs.  Our approach is to ensure that we use the right system to meet your needs.  

Our core in-house database:

  • Has an integrated submission management tool for direct submissions, detailed search functionality and simplified signal detection.
  • Is fully E2B and CFR21 Part 11 compliant. 
  • Allows:
    • E2B-compliant XML file import and export
    • Recording of Individual Case Safety Reports (ICSRs)
    • Creation of:
      • Summary tabulations
      • MedWatch format reports
      • CIOMS I format reports
      • Line-listings


Business Cases

  • Case Study detail

    Local Pharmacovigilance Management

    Global Pharma Company, United States
  • Case Study detail

    Full outsourced EU Pharmacovigilance system

    Leading Generic company, North America

Contact Us

If you want to dicuss how you can be safe in our hands, please contact us for a consultation.

Telephone: +353 125 44033

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