Pharmacovigilance & Safety Reporting
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 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.
