Oracle Argus Safety Suite

The Oracle Argus Safety Suite is the most advanced drug safety, pharmacovigilance, and risk management solution available. It is trusted by safety and risk management departments everywhere, making it the most widely used adverse event reporting system in the world. The Oracle Argus Safety Suite is comprised of the following:

Oracle Argus Safety: Provides the most comprehensive global adverse events (AE) case data management and regulatory reporting in the pharmaceutical industry. With more licensed users than any other drug safety software system in the world, Argus Safety is the trusted solution.

Oracle Argus Affiliate: Eliminates data entry due to local affiliate cases and enables simultaneous multi-user access to the same case—all while providing the central office with visibility into what is submitted by local affiliates.

Oracle Argus Dossier: Allows pharmaceutical companies to manage the entire lifecycle of periodic safety update report (PSUR) dossiers in a timely and efficient manner.

Oracle Argus Insight: Provides a visionary tool for multi-dimensional analysis of drug safety data, easy-to-use drill-down review of drug safety data by common attributes, creation of frequently required pre-formed, filterable reports on an ad-hoc basis, and an all-in-one solution for workflow and departmental metrics.

Oracle Argus Interchange: Enables electronic exchange of data with partners and regulators. Seamlessly integrated with Oracle Argus Safety, provides a familiar user interface and report scheduling process while eliminating reliance on third-party vendors to submit reports. This solution also connects e-clinical systems to the drug safety database via the CDISC:ODM - ICH:E2B standards.

Oracle Argus Japan: Provides essential support for Japanese Pharmaceuticals and Medical Devices Agency (PMDA) expedited reporting in the required Kanji format. A single, global database accommodates both Kanji and Western character sets, thereby avoiding reconciliation issues and completely integrating Japan into the global business process.

Oracle Argus Perceptive: Extends the industry-leading Oracle Argus Safety solution far beyond adverse event reporting to deliver an integrated solution for pharmacovigilance and risk management.

Oracle Argus Reconciliation: Automates the process of reconciling adverse event reports between Oracle Argus Safety and clinical systems as well as managing resulting variations.