Synchronize and Simplify Drug Safety Aggregate Reporting
Marketing Authorization Holders (MAH) are expected to prepare and submit aggregate safety reports to regional and global regulatory bodies to account for the medicine’s safety profile over an extended period of time. These periodic reports shall be used for assessing the risk-benefit of the product and taking appropriate action where new risks or changes to known risks are identified.
Key Product Features
Seamless Integrations with various source systems to enable 100% process automation
- Drug Safety Database
- Signal Management System
- Clinical Systems
- Quality Management System
- Literature Screening
- Other modules of Sentinel
- Other organization wide operational data source systems
Aggregate Reporting is a component of our Sentinel platform. It can be deployed on its own or in combination with other modules of the platform.
How Do we Deliver
Our technology platform, process accelerators and subject matter expertise enable you with a comprehensive solution to digitalize and automate the entire compliance associated with aggregate reporting. Our solutions are flexible, modular and can be deployed by MAH, QPPV office and CRO companies globally or at local entities.