Adverse Events
The Medical Information department at many pharmaceutical and biotech companies is often the first line for receipt of potential adverse events. Smaller companies often have the same professionals handling both medical information requests and adverse events. Historically there has been a wall between systems used for medical information and systems used to capture and report adverse events. That no longer needs to be the case.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 and easy to use and integrates fully with IRMS, the worlds leading medical information system.
This integration allows for a single point of entry for medical information, contact and correspondence management and 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 and IRMS-AE Full Reporting.
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 mode 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 WHODic integration. IRMS-AE uses E2B to send requests electronically to the FDA or other drug safety systems.