Oracle Argus Safety

PRODUCT DESCRIPTION

Oracle Argus Safety is an advanced and comprehensive adverse events (AE) management system that helps life sciences companies enable regulatory compliance, drive product stewardship, and integrate safety and risk management into one comprehensive platform. Argus Safety is industry-proven and accepted, having been used for more than a decade at leading pharmaceutical, biotech, CRO, and medical device manufacturers.

Oracle's proactive approach to monitoring global guidances helps enable consistent regulatory compliance, including ICH, EMEA, and FDA and many national authorities. It is fully ICH:E2B compliant, and integration with Oracle Argus Interchange enables companies to electronically exchange information with regulators. Argus Safety supports electronic communication with trading partners and CROs, providing visibility into compliance across a company’s global licensing partnerships.

Argus Safety also supports a company’s end-to-end pharmacovigilance program by providing a holistic view of product stewardship, from clinical trials through post-marketing surveillance. By integrating SAEs from clinical trials, companies have the opportunity to manage efficacy earlier in the drug lifecycle and can potentially address public health concerns sooner.

Argus Safety seamlessly integrates with Oracle Argus Insight and Oracle Argus Perceptive to provide a comprehensive safety and risk management platform. It includes a comprehensive tool set for expedited and periodic reporting, signal detection and management, clinical trial SAE reconciliation, and partner AE management.

FEATURES AND BENEFITS

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)
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