Oracle Argus Safety Suite | Oracle
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Oracle Argus Safety Applications

Oracle's Argus Safety suite is an advanced drug safety and risk management solution. It is a proven and highly scalable system in use at global pharmaceutical companies, medical device manufacturers, biotechs, and CROs of all sizes. The Argus Safety suite is a fully integrated platform of end-to-end pharmacovigilance solutions designed to ensure regulatory compliance and comprehensive product stewardship, from clinical development all the way through post-marketing surveillance.

Oracle Argus Safety: Provides comprehensive global adverse events (AE) management and regulatory reporting for the life sciences industry. Advanced functionalities such as extensive automation, configurable workflow, and managerial and executive dashboards enable maximum case-processing efficiency and help ensure regulatory compliance, while freeing pharmacovigilance departments to focus on the effectiveness of their products.

Oracle Argus Affiliate: Enables life science companies to remain in global regulatory compliance by supporting affiliate sites and licensing partners. Companies gain greater visibility into pharmacovigilance activities by local affiliates and among partners, lowering risk from unanticipated reporting delays. It also increases overall case-processing efficiency by automating time-consuming tasks and eliminating the need for double data-entry and subsequent reconciliation.

Oracle Argus Interchange: Enables electronic exchange with partners and regulators, supporting maximum efficiency and worldwide regulatory compliance. Argus Interchange is seamlessly integrated in the Oracle Argus Safety suite. It allows companies to efficiently process adverse events and collaborate more effectively with global license partners.

Oracle Argus Safety Japan: Helps to significantly reduce the total cost of ownership for global pharmaceutical companies by eliminating the need for multiple systems, avoiding costly reconciliation issues, and completely integrating Japan into the global business process. It 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, greatly increasing the efficiency of adverse event management for the Japanese life sciences industry.

Oracle Argus Reconciliation: Supports the industry's end-to-end pharmacovigilance activities from clinical development through post-marketing. It automates the cumbersome process of reconciling serious adverse events (SAE) between Argus Safety and clinical systems. By eliminating a costly step in the business process, Argus Reconciliation can lower the cost of compliance for sponsors and CROs.

Oracle Argus Dossier: Allows pharmaceutical companies to manage the entire lifecycle of periodic safety update report (PSUR) dossiers in a timely and efficient manner, which helps to ensure compliance and lower the cost of reporting. Argus Dossier eliminates resource-intensive, manual, periodic reporting processes and shifts the paradigm from data collection to data analysis.

Oracle Argus Insight: Delivers an advanced tool for multidimensional analysis of drug safety data. Argus Insight's knowledgebase can be utilized by life sciences companies to manage drug safety, clinical trial, product dictionary, and clinical trial data—all without impeding the use of the important Argus Safety adverse event management system.

Oracle Argus Perceptive: Extends a life sciences company's capabilities far beyond adverse event reporting to deliver an integrated solution for signal management. Argus Perceptive addresses all critical components of risk management, including risk identification, risk analysis, risk mitigation, and portfolio management.