- Manage cases with combination products
- Manage cases with products with different regulatory statuses depending of country
- Improve collaboration among teams in real-time with deadline & reminder management systems.
- Edit reports in the blink of an eye without waiting for the system to load.
- Get automatic system updates to stay current with the latest regulations.
Spontaneously generate submission ready regulatory reports automatically populated with entered data.
- CIOMS & MedWatch
- Periodic Safety Update Report (PSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Development Safety Update Report (DSUR)
- Signal detection, line listings & summary tabulations