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ICON ORCA Safety

Automated technology supported by pharmacovigilance expertise and global regulatory intelligence to monitor and manage patient safety

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Combining pharmacovigilance expertise and global regulatory intelligence with innovative technology to protect patient safety, maintain compliance and decrease costs

  • 100+ countries monitored

    Stay up to date with regulatory developments

  • 22-hour coverage

    Access global support whenever you need it

Key features

Developed on an innovative cloud-based system with automated and configurable business rules, the ICON ORCA safety features reporting functionality and a dashboard showing both individual and aggregate submissions at a study and portfolio level.

This provides you with increased transparency to monitor and manage developments and visibility into the safety profile of an investigational product throughout its lifecycle.

  • Dedicated regulatory intelligence in 100+ countries
  • 22+ hour global submission coverage
  • Validated compound level safety reporting system that delivers significant cost and time savings over traditional protocol-level reporting solutions
  • E2B (R3) enterprise edition safety database
  • Integrated compliance management

Increasing compliance, decreasing site burden

The result is higher quality, increased speed and stronger regulatory compliance. In addition, compound level reporting removes duplication of notifications to those sites participating in multiple studies investigating the same compound, thereby reducing investigator burden.

Learn more about our powerful safety reporting solution

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