Oracle Argus Supports E2B(R3) Exchange with the European Medicines Agency’s Enhanced EudraVigilance System

Oracle Health Sciences today announced that the latest release of Oracle Argus, the company’s safety and pharmacovigilance software, fully supports E2B(R3) exchange with the European Medicines Agency’s (EMA’s) enhanced EudraVigilance (EV) version 8. Both Oracle Argus cloud and on-premise deployments have been tested and are fully compliant with the new EV system.

November 22, 2017 marked the go-live date for the new EudraVigilance upgrade that introduced the E2B(R3) standard for the electronic transmission of individual case safety reports (ISCRs) in Europe. The support of the new standard was one of a series of enhancements introduced to achieve full functionality with the requirements set out in Regulation (EC) No 726/2004.

Oracle Argus is a platform that enables biopharmaceutical companies, medical device manufacturers, and contract research organizations (CROs) to make faster and better safety decisions, optimize global compliance, and easily integrate with the Oracle Health Sciences Empirica platform for signal management. Argus automates and streamlines the entire multi-vigilance lifecycle for drugs, vaccines, and devices from clinical trials through post-marketing surveillance.

“We designed Argus to ensure that our life sciences customers will always be compliant with the latest regulations anywhere in the world, and to give the best possible protection to their sensitive safety data and ultimately to patients,” said Steve Rosenberg, SVP and General Manager, Oracle Health Sciences.

“Global compliance is a critical requirement, and in advance of this release, we held a customer pilot, participated in an EMA pilot, and performed EMA compliance testing,” he continued. “We develop each new version of Argus only after a thorough review of all relevant and upcoming regulations that will affect our customers, such as the recent adoption of E2B(R3) by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.”

Oracle Health Sciences tested its recent version of Oracle Argus directly with the EMA to ensure it met the European requirements for E2B(R3) and to give its life sciences customers peace of mind knowing that they are compliant with the new safety reporting standard. Unlike solutions that require heavy customization, Oracle Argus provides deep and integrated safety functionality out of the box, scales to millions of cases, and easily aligns with users’ safety and business processes. The platform enables organizations to simplify processes, reduce cycle times, and make in-stream decisions, while enabling collaborative workflows within and across the company to ensure the highest level of patient safety in both clinical development and post-marketing.