Safety Reporting and Pharmacovigilance

IRMS-AE - Adverse Event Reporting Software

Adverse Event Reporting Software

A Full Drug Safety System

IRMS-AE is our comprehensive, feature-rich, drug safety system. It can fully handle all adverse event reporting 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 Drug Dictionary integration.

Electronically Send Requests with E2B

IRMS-AE uses E2B to send requests electronically to the FDA or other drug safety systems. Comprehensive, collaborative and user-friendly periodic AE reporting encompassing PSUR, ASR, DSUR, PADER and more reduces the time required to produce periodic submissions while increasing their accuracy.

IRMS-AE Key Features Include:

  • Ability to generate full MedWatch, Periodic, CIOMS and PSUR reports
  • Fully 21 CFR Part 11 compliant, IRMS has full audit trails and user logs
  • Complete security control and required fields managed through system parameters
  • Advanced product and event capture capabilities
  • MedDRA and WHO Dictionary integration
  • E2B submission to the FDA

Advanced AE Case Management provides:

  • Individual tracking of each report
  • Advanced data management for follow-ups
  • Lock dates for periodic reports

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A Second Mode of Operation:

Adverse Event Drugs

The IRMS-AE Capture module is designed for companies that have an existing Adverse Event system already in place. IRMS-AE allows for the capture of detailed Adverse Event data, from patient and medication information to MedDRA coding and outcome data. This information can then be transferred to the appropriate safety department or safety system either manually or automatically.

Allows you to capture:

  • Patient and outcome related information
  • Multiple suspect and concomitant medications
  • Multiple AE terms with all related information
  • Multiple test and lab data
  • Multiple previous medical history information
  • Detailed case activity, with dates and notes

Full IRMS Integration

IRMS-AE is designed to fully integrate with its medical information system parent solution, IRMS. This integration allows for a single point of entry for all Pharmacovigilance, 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 any existing industry standard adverse event systems.

Cloud-based Deployment Options

The IRMS-AE solution can be deployed as a cloud-based package or implemented on premise. With either solution, IRMS-AE provides for configurable security parameters which allow for partner case processing. Partners, Vendors or affiliates can utilize a single interface and repository for safety cases, eliminating duplicate data entry and the risk of conflicting case data.

Use Your Own Workflow Process

IRMS and IRMS-AE is designed to easily configure to your own processes without customization, including unique configurations for different affiliates and partners using the same implementation. This can greatly improve efficiency and collaboration while still ensuring adherence to global and local regulations.

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