Combining pharmacovigilance expertise and global regulatory intelligence with innovative technology to protect patient safety, maintain compliance and decrease costs
100+ countries monitored
Stay up to date with regulatory developments22-hour coverage
Access global support whenever you need it
Key features
Developed on an innovative cloud-based system with automated and configurable business rules, the ICON safety reporting system features reporting functionality and a dashboard showing both individual and aggregate submissions at a study and portfolio level.
This provides you with increased transparency to monitor and manage developments and visibility into the safety profile of an investigational product throughout its lifecycle.
- Dedicated regulatory intelligence in 100+ countries
- 22+ hour global submission coverage
- Validated compound level safety reporting system
- E2B (R3) enterprise edition safety database
- Integrated compliance management
Increasing compliance, decreasing site burden
The result is higher quality, increased speed and stronger regulatory compliance. In addition, compound level reporting removes duplication of notifications to those sites participating in multiple studies investigating the same compound, thereby reducing investigator burden.