Configure to support your organizational processes, including:
Risk Evaluation Models,
Designed by RBQM Operational experts, OPRA RAM supports the implementation of a standardized, ICH E6 5.0 compliant, end-to-end risk management process.
OPRA CM supports the central review of patient and site data as described in ICH E6 5.18.3 using statistical models, visualizations, aggregate data tables and data listings.
Quickly and easily access the detail about each risk, including the risk rating and whether it's improving or deteriorating. Assign actions and proactively manage risks directly in OPRA.
Reporting is quick and easy for both risks and central monitoring. Choose from the pre-configured reports or create your own. Create reports that can become the inspectable records for your Central Monitoring activities.