Trifecta’s state-of-the-art technology for delivering and tracking global Safety Letters reduces workload, standardizes processes, and ensures compliance with FDA and ICH regulations. And like all of our solutions, it is easy to use.
Features of SafetyVigilance:
- Electronic delivery of Safety Letters to Investigational sites sent through our secure, online SafetyVigilance®1
- Real-time administrator tracking and reporting capabilities
- Automatic email alert notification and reminders for Safety Letter review
- Investigators can review and print the Safety Letter according to site SOPs
- Electronic signature confirms receipt by investigators1
- Safety Letters can be grouped by compound, study, or protocol and may be sent individually or batched.
1 Compliant with 21 CFR Part 11 guidelines