Oracle Argus Perceptive

Oracle Argus Perceptive is a key component of Oracle's risk management suite. Argus Perceptive addresses all areas of risk management, including risk identification, risk analysis, risk mitigation, and portfolio management. Crucial to regulations such as CIOMS VIII, Argus Perceptive provides the framework for a more comprehensive structured signal management process to analyze and mitigate risk. It can be utilized with any adverse event reporting system to help manage a drug’s benefit/risk profile.

Argus Perceptive helps life sciences companies proactively detect safety signals via real-time monitoring of product-event combinations. It leverages both industry-standard as well as unique data-mining algorithms. Argus Perceptive gathers data from multiple sources for more accurate signal detection, including clinical and external data.

More than just simple signal detection, Argus Perceptive also provides an integrated platform for real-time risk analysis. To help ensure regulatory compliance, it supports tracking of regulatory inquiries for ongoing risk management obligations from RMPs and REMS. For additional analysis, it integrates seamlessly with Oracle Argus Insight, the pharmacovigilance business intelligence and analytics tool.

Argus Perceptive offers a structured approach for risk mitigation, ensuring adherence to the company-defined SOP for triage, assessment, mitigationm and follow-up. It enables a continuous process of assessment and mitigation based on a product’s identified risk. Over time, Argus Perceptive builds an invaluable knowledge base for risk assessors. In this way, Oracle’s risk management solutions help life science companies move beyond mere compliance to focus on holistic product stewardship.

Features

• Multiple statistical analysis tools
• Automated primary and secondary alert detection
• Drill-down analysis
• Intelligent triage and notification features based on user-defined thresholds
• Automated data mining engine
• Automated escalation of safety concerns

Integration

• Integrates with Oracle Argus Safety and Oracle Argus Insight
• Integrates with any adverse event reporting system
• Integrates with multiple statistical engines for analysis, alert detection, and case series management
• Offers integrated comprehensive knowledge base

Compliance and Reporting

• Management monitoring tools, reports, and escalation environment
• Comprehensive audit trail and activity log
• Independent workflow for risk assessors
• Signal detection report preparation and workup environment