eSafety

eSafety, developed by CIMS Global, is a dedicated system for seamless processing and reporting of Serious Adverse Events (SAEs) throughout the clinical trial lifecycle. Designed to empower Drug Safety Groups to work more efficiently, eSafety streamlines SAE management from initial capture through to regulatory submission, reducing manual effort and minimising the risk of delays or errors.

eSafety is available as a standalone safety management system or natively integrated with CIMS' Electronic Data Capture (EDC) platform, offering flexibility to fit a variety of study configurations and organisational needs.

Key Features

• Easy SAE Reconciliation: eSafety auto-populates SAE-related information directly from eCRFs into the SAE report, automatically transferring data to Individual Case Safety Reports (ICSRs) and then to the regulatory report in the safety database, eliminating redundant data entry.
• Efficient Case Management: Updated data is highlighted within both the SAE report and ICSR to facilitate easy review. Narrative changes are tracked over time, and medical review queries can be posted directly on the SAE report and resolved within the system.
• Seamless Query Management: When eSafety is integrated with the EDC, case review queries can be posted directly on the SAE report, enabling sites to review and address queries without leaving the system.
• Flexible Usage: The system can be deployed as a fully integrated component of the CIMS EDC environment or operated independently as a standalone safety management solution.
• Case Review Notifications: Automated email notifications ensure that each SAE case is processed and reported within the required regulatory timeline, keeping the Drug Safety Group informed and on track.
• Drug Safety Monitoring: eSafety can be combined with CIMS' Dynamic Data Monitoring (DDM™) tool, providing an innovative approach to real-time safety data monitoring and signal detection throughout the duration of a clinical trial.

Workflow Capabilities

• Automatic data transfer from eCRFs to SAE reports and ICSRs reduces manual transcription and reconciliation effort.
• Highlighted data updates within reports allow reviewers to quickly identify changes between versions.
• Integrated query management supports direct communication between the safety team and clinical sites within a single platform.
• Timeline-based email notifications support compliance with regulatory reporting requirements.
• Real-time signal detection is enabled through optional integration with the DDM™ monitoring tool.

eSafety supports both standalone deployment and full integration with CIMS' EDC system, making it adaptable for sponsors and CROs managing safety data across diverse clinical trial environments. Its combination with the DDM™ tool further extends its capabilities into proactive, real-time pharmacovigilance monitoring.