With integration of both clinical database and safety database in CIMS, eSafety features comprehensive SAE management within CIMS with email notification and auto-populating of related information such as SAE Term, onset date, serious criterion, severity, relationship to study drug, outcome, and action taken, Concomitant Medications, Medical History and Lab results into the safety database. Therefore, no or minimal effort will be required to reconcile the two databases at the end of the study.
This module provides a platform for the Drug Safety Group to work on SAE tracking, querying and narrative writing, and medical assessment. Standard regulatory forms (e.g. MedWatch, CIOMS) are auto-populated and ready for regulatory submission. The module also equips with E2B R3 model for international transmitting of safety report.
The eSafety module can be detached from CIMS as a standalone safety management system. Combined with the Dynamic Data Monitoring (DDM) module, eSafety+DDM can monitor drug safety and signal detection in real-time.