Oracle Introduces Oracle Argus Safety 7.0

Supporting health sciences organisations’ commitment to ensuring the safety and effectiveness of their products, Oracle has announced the availability of Oracle Argus Safety 7.0, a market-leading integrated global adverse events (AE) management and regulatory reporting solution. From a single instance of the solution, the new release enables health sciences organisations and contract research organisations (CROs) to maintain separation among and securely manage safety data from firms across the complex network of customers and business partners required for product development in the health sciences industry.

The Oracle Argus Safety 7.0 also features new capabilities, such as standardised configurations and rules management, as well as centralised coding-dictionary management, all of which enable rapid set up and maintenance of new safety datasets, regardless of their source. In addition, the solution reduces the resources required for ongoing maintenance through a single, global user management and administration tool.

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With its new extensible portal, Oracle Health Sciences Argus Safety 7.0 also helps organisations establish and manage organisational safety priorities appropriately across all products and stakeholders from a single interface. The solution’s role-based workflows and work lists help ensure that users are aware of overall priorities and focused on the most critical events.
Oracle Argus Safety 7.0 is part of Oracle’s set of comprehensive solutions to manage pharmacovigilance, signal detection and proactive risk management across the product lifecycle.

“Product development in the health sciences industry is increasingly virtualised and complex, often spanning the globe and requiring the management of safety data from numerous co-marketing, in-licensing, and partner entities,” said Neil de Crescenzo, senior vice president and general manager, Oracle Health Sciences. “Health sciences enterprises and their partners seek secure and efficient ways to manage this data across partners. Oracle Health Sciences Argus Safety 7.0 answers this call, enabling organisations to manage multiple datasets in a single instance while meeting 21 CFR Part 11 requirements. The end result is the ability to lower IT costs and reduce management and compliance complexity.”