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

Sponsor

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

CRO

  • Faster package assembly
  • Online query
  • Online coding

Adjudicators

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

 

10%

Decrease in CEC adjudication time

30%

Decrease in endpoint and package processing time by CRO

75%

Decrease in translation turnaround time

90%

Decrease in shipping costs

Safety Database Hosting

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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