eSafety
Empower the Drug Safety Group to work more efficiently.
CIMS’ eSafety system provides seamless processing and reporting of Serious Adverse Events (SAEs). It is available both stand alone or natively integrated with our EDC. The eSafety features easy SAE reconciliation, streamlining SAE management throughout the study and during the regulatory submission process.
Key Features
Easy SAE Reconciliation
The eSafety auto-populates SAE-related information from the eCRFs to the SAE report, automatically transferring data to the individual case safety reports (ICSR), and then the regulatory report in the safety database.
Efficient Case Management
Updated data is highlighted in both the SAE report and ICSR for easy review. Narrative changes are tracked, and medical review queries can be directly posted on the SAE report and resolved within the system.
Seamless Query Management
When eSafety and EDC are integrated, case review queries can be directly posted on the SAE report for the site to review and address.
Flexible Usage
The eSafety system can be integrated with the EDC system or used as a standalone safety management system.
Case Review Notifications
Email notification ensures that each SAE case is processed and reported within the required timeline.
Drug Safety Monitoring
Email notification ensures that each SAE case is processed and reported within the required timeline. The eSafety system can be combined with the CIMS’ Dynamic Data Monitoring (DDM™) tool, offering an innovative approach to real-time safety data monitoring and signal detection throughout the clinical trial.
Schedule a demo with us and learn about eSafety.
Schedule a demo with us to learn about eSafety and how it can benefit your organization.
