Miami, Florida, April 26, 2018 – ArisGlobal, a leading provider of integrated cloud-based software solutions for life sciences, today announced LifeSphere® EV Triage, an intuitive, cloud-based plug-in tool that automates the process of triaging and reconciling applicable individual case safety reports (ICSRs) involving a marketing authorization holder’s (MAH) medicinal products from other non-specific cases. The plug-in tool features an intuitive user interface and is fully interoperable with any pharmacovigilance (PV) system or E2B converter tool. As a result, greater efficiencies are achieved as the amount of manual effort involved is significantly reduced.
“As part of new EudraVigilance (EV) pharmacovigilance legislation enacted in November 2017, today’s Marketing Authorization Holders (MAHs) no longer receive ICSRs from National Competent Authorities,” said Dr. Vivek Ahuja, Vice President, Global Pharmacovigilance, ArisGlobal. “Now they must download safety cases from EVWEB, which are based only on the active substance as per the hierarchy of XEVMPD. For most products, it is estimated that the majority of the cases downloaded are not relevant to a MAH’s product. This manual process involves a significant manual effort and creation of Excel spreadsheets to determine which ones are specific to a company. LifeSphere EV Triage entirely removes that pain point and replaces it with efficiency, ease and speed.”
For ICSR triage, upon downloading the XML ZIP file from EVWEB, LifeSphere EV Triage unzips the file and runs an auto-match algorithm that is based on the MAH’s product-specific tags, such as local trade name, substance name/ingredients, form of administration, route of administration, and country. Based on those tags, incoming reports are then segregated into “Applicable ICSRs,” which are sent for further processing to the company’s PV system, and “Potential ICSRs,” which are archived for future reference.
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.
For easier and more thorough case reconciliation, LifeSphere EV Triage extracts data if needed and checks how many ICSRs were received, imported and rejected.