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