Adverse Events
IRMS-AE
Adverse Events
IRMS-AE, our comprehensive adverse event module for the Information Request Management System (IRMS), is a full, feature-rich drug safety system. The tab based system is user-friendly, easy to use, and integrates fully with IRMS.
This integration allows for a single point of entry for medical information, contact and correspondence management, adverse event data entry, and reporting. Additionally, the full IRMS-AE system allows for real-time case transfer to industry-standard Adverse Event systems.
IRMS-AE has two modes of operation:
IRMS-AE Capture
The IRMS-AE Capture module is designed for companies that have a full Adverse Event system already in place. IRMS-AE allows for the capture of detailed Adverse Event data, from patient and medication information to MedDRA and outcome data. This information can then be transferred to the appropriate safety department or safety system either manually or automatically.
IRMS-AE Full Reporting
This module can fully handle adverse events, including MedWatch, CIOMS, and periodic reports. Features include full metrics reporting, tracking and querying capabilities, follow-up reports, advanced product and event capture capabilities, and MedDRA and WHO Dictionary integration. IRMS-AE uses E2B to send requests electronically to the FDA or other drug safety systems.
IRMS-AE Features Include:
Allows capture of:
Advanced Case Management provides:
