Oracle Argus Safety

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 leading, trusted drug safety solution to manage the entire case lifecycle.

Argus Safety complies with all major regulatory reporting guidelines, including the European Medicines Agency (EMEA), U.S. Food and Drug Administration (FDA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA). Argus Safety's proactive approach to monitoring global guidances ensures consistent regulatory compliance. It is fully ICH:E2B compliant, and integration with Oracle Argus Interchange enables companies to electronically exchange information with partners and regulators.

Argus Safety is a scalable, high-performing, and proven fourth-generation Web-based system. This centralized and easy-to-use system delivers many benefits, including simplified rollout and deployment, low long-term maintenance costs, and effortless upgrades. Argus Safety Web fully supports all standard dictionaries, including MedDRA, CoSTART, WHO-ART, WHO-DRUG, and ICD-9-CM, and can support any global workflow model. The steps involved in processing individual case reports can be configured to match any unique business process, whether centralized or decentralized.

Argus Safety seamlessly integrates with Oracle Argus Insight and Oracle Argus Perceptive to deliver powerful risk management analysis tools to ensure comprehensive product stewardship. Based on how a product is interpreted by local regulatory authorities, Argus Safety enables the product to be reported as a drug in one market and as a device or a vaccine in another market.

Productivity Enhancements

• Compliance and productivity metrics
• Fully configurable workflow via user interface
• Automated global expedited reporting
• Electronic exchange
• Automation of narratives, coding, action items, and letters (query)
• Case versioning and data lock point
• Single screen for convenient medical review
• Complaints data capture
• Dashboards
• Central coding support

Technology and Integration

• Integrated affiliate support with local entry, assessment, and reporting
• Integrated with clinical systems (CDISC:ODM to ICH:E2B)
• Fully integrated MedDRA and WHO-Drug browsers
• Documentum, Cognos, and Business Objects integration
• Source document and enterprise content management integration
• API for rapid integration
• Integrated with Oracle Argus Insight and Oracle Argus Perceptive to deliver comprehensive risk management capability
• Single sign-on access to all Oracle Argus suite modules
• IT backbone integration (LDAP/ADS, e-mail, fax)