Pharmacovigilance & Safety Reporting

Safety Notification Management



Get notifications of submissions of SAEs and SUSARs in real time, and enable instant translation submission for forms coming from international sites.

Endpoint Adjudication


  • Visibility into all cycle times
  • Customized reports
  • Real-time data on key deliverables


  • Faster package assembly
  • Online query
  • Online coding


  • Real-time access to endpoint
  • E-Adjudication card built in
  • E-CRF card built in



Decrease in CEC adjudication time


Decrease in endpoint and package processing time by CRO


Decrease in translation turnaround time


Decrease in shipping costs

Safety Event Tracker

Collect and store cases received (ADRs, medical information, product complaints, non-case calls)
in a 21 CFR Part 11 compliant, validated, web-based global database.

Pharmacovigilance System Master File

Turn your hard copy PSMF documentation into a centrally stored, real-time accessible online file, available to regulatory inspectors, global teams, and approved partners.

Comply with the EMA’s GVP requirements outlined in Module II.

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