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Oracle announced the availability of Oracle Argus Safety 7.0, an integrated global adverse events (AE) management and regulatory reporting solution.
The newest release enables health sciences organizations and contract research organizations (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. Thisapproach eliminates the operational requirements and IT costs associated with setting up and managing several instances of a traditional safety solution in an enterprise, while maintaining stringent security controls and facilitating compliance with US Food & Drug Administration (FDA) 21 CFR Part 11 electronic record and signature requirements.
"Product development in the health sciences industry is increasingly virtualized 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 Argus Safety 7.0 also features new capabilities, such as standardized configurations and rules management, as well as centralized 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. With its new extensible portal, Oracle Health Sciences Argus Safety 7.0 also helps organizations establish and manage organizational 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.