Configure to support your organizational processes, including:

Risk Evaluation Models,

Risk Libraries


Control Libraries


Improve and scale your central monitoring processes with standard:

Risk Indicators,

Data Visualizations,

Data Tables


Root Cause Analysis



OPRA tailors RBQM

for your organization

Get the most powerful
Risk Assessment, Risk Management & Central Monitoring tools
personalized for your trials.

Designed by RBQM Operational experts, OPRA RAM supports the implementation of a standardized, ICH E6 5.0 complaint, 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.

Risk Dashboard

See all your most important risk information in one place. Configure the dashboard to show the data you need to instantly identify trends and problems.

OPRA Clinical Trial RBQM Risk Log RBM Risk Based Monitoring Risk-Based Quality Management ICH E6 (R2) E8
Risk Log

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.

Risk Evaluation Model Builder

Create a bespoke risk evaluation model specifically for your organisation.  Define values for Likelihood, Impact and Detectability based on your risk culture.

OPRA Risk Evaluation Model Builder for RBQM Risk-Based Quality Management RBM Risk Based Monitoring ICH E6 (R2) E8
Central Monitoring
Study Dashboard

See your most important study KRI's in one place. Create your own or choose from OPRAs extensive KRI library.

Central Monitoring KRI Drill-Down

Use the drill-down and companion information features to access the detail you need quickly and easily.

Central Monitoring
Site Dashboard

See site level information at the click of a button. Use the drill-down features to see what's really going on.

OPRA Reporting

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.

Find out about the services we provide with OPRA to ensure your RBMQ implementation is successful