SafetyReady

Safety and Efficacy of a medical product are of paramount importance to Life Sciences organizations. In order to efficiently manage the Adverse Events (AE) captured during the life cycle of a medicinal product it is critical to have a Safety Management System in place. These systems not only automate the case management process but also provide metrics and reporting for efficiently managing the adverse event capture and reporting process.

Business Need

• Rapid and cost effective implementation of a Safety database
• Validation and verification of safety system
• Effective staff training on the new system
  

Service Highlights

With TAKE’s SafetyReady™ an organization can operationalize Oracle Argus Safety based integrated platform for end-to-end pharmacovigilance solutions, ensuring regulatory compliance and comprehensive product oversight, from clinical development to post-marketing surveillance.

• MySafetyReady portal – an interactive e-control room for implementation
• Specification Accelerator – a pre-populated URS with standard user requirements based on current regulations
• Configuration Accelerator – automates key configuration settings
• Reporting Accelerator – a set of simple and flexible rules conforming to the ever evolving regulatory reporting requirements
• Workflow Accelerator – an industry best practice model workflow as part of the install, that is completely receptive to the users unique workflow
• Validation Accelerator – readily available test scripts which ensure conformance to the validation requirements set by the 21 CFR Part 11
• Training – extensive training tailored for specific roles
  

With these accelerators the organization could be running the safety systems in as little time as five weeks.