Oracle Argus Perceptive

Oracle Argus Perceptive was designed specifically for global regulatory pharmaceutical risk management. Argus Perceptive combines with any adverse event reporting system to deliver powerful analytics and assessment of drug safety data. Argus Perceptive is an instrumental component for pharmaceutical risk management: it is a fully auditable tool for signal detection, management, early communication, and documentation. It provides a focal point for risk analysis, allowing users to center attention on the adverse event reports that are most important.

Argus Perceptive allows users to define the type of advanced statistical analysis required for customized reports (PRR, Chi-Square, and 95-percent confidence intervals). Its powerful analytical and assessment tools provide visualization and real-time analysis of pharmacovigilance data.

Argus Perceptive's searchable knowledge base for signal workup enables early risk assessment. Automated data mining enables re-evaluation of previously dismissed signals for secondary review and assessment. This central knowledge base can also contain external data, such as epidemiological studies, to support all reporting needs.

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