LifeSphere^® EV Triage

Automating the Triage of MAH-Applicable E2B (R3) Cases from EVWEB

As marketing authorization holders (MAHs) strive to meet the EMA requirement of downloading E2B (R3) files from the EVWEB portal, LifeSphere EV Triage is the cloud-based software tool that automates the triage process of segregating and reconciling applicable cases from other non-relevant cases. PV processing teams no longer have to spend many manual hours reviewing and determining which downloaded cases have any relevance to company products. For easier and more thorough case reconciliation, LifeSphere EV Triage extracts data if needed, and checks how many ICSRs were received, imported and rejected. Now PV teams can spend time on more critical tasks.

LifeSphere EV Triage can be used with any PV system or E2B converter, and leverages an intuitive user interface to significantly reduce the manual effort required to separate the cases relevant to the MAH. The plug-in tool also directly imports relevant cases to LifeSphere^® Intake and Triage, a sophisticated case triage solution that enables drug and device companies to manage the intake, receipt and triage of adverse events (AEs) automatically from a wide range of sources, including email, fax, online portal, electronic gateways and mobile apps.

After downloading the XML ZIP file from the EVWEB, the tool unzips them and runs an auto-match algorithm based on the MAH’s product-specific tags, such as local trade name, substance name/ingredients, form on administration, country, and route of administration. Based on the identified tags in those downloaded XML files, all incoming reports are tagged either as Applicable ICSRs or Potential ICSRs. All Applicable ICSRs are sent for further processing to the PV system of choice, while Potential ICSRs are automatically archived for future reference.