TRI Risk-Based Quality Management RBQM software technology for risk assessment, risk management and central monitoring


OPRA - The Industry leading RBQM Technology

OPRA gives you complete end-to-end Risk-Based Quality Management for all your clinical trials. It improves data quality, increases patient safety, and reduces your monitoring costs by focusing your valuable resources on the most important areas. All through one powerful and easy-to-use platform. There are two modules: Risk Assessment & Management (RAM); and Central Monitoring.
 

20211206 300 x 200 OPRA Data Journey v7-20.jpg

Use our comprehensive library of data exports and standard reports to report on risks and risk management activity.

 

Export pdf reports for inclusion in TMF. 

A comprehensive reporting suite for: ongoing risk management; central monitoring; quality management activity; CRO and Sponsor collaboration; and inclusion in the Trial Master File.

Develop your own risk evaluation model or use our standard models.

 

Evaluate each risk and re-evaluate during risk reviews to prioritize what's important, and see trends over time.

Identify and capture data and processes critical to quality.

 

Record supporting metadata, such as data source and justification for inclusion.

Assign risk controls, KPIs, KRIs and QTLs to your risks from your controls library, or by defining new controls.

 

Assign control owners, review frequencies and links to central monitoring. 

Detail the risks to each critical variable, either by importing from your risk library or adding new risks.

 

Assign functional ownership, review frequency and other key characteristics of risk.

Communicate risk and risk control ownership.

 

Document risk management activities, decisions and timelines.

Set risk review alerts and review risk dashboard and risk log.

 

Update and add new risks and controls as needed.

 

Use the intuitive dynamic UI to drill down to risk details and review risk trends over time.

 

Seven steps to risk management
success with
 OPRA

1 - Define your operating environment

Define user roles, access levels, libraries, review cycles and pick lists. Determine which customers, partners and vendors will collaborate in your risk management and assign access and security levels.

OPRA RBQM Technology Software Risk Assessment and Management (RAM) organization set-up screenshot
OPRA RBQM Technology Software Risk Assessment and Management (RAM) Risk Evaluation Model Builder.png
2 - Define your risk scoring model

Create a bespoke risk evaluation model specifically for your organization.  Define values for Likelihood, Impact and Detectability based on your organization's risk culture and build tool tips into your scores to help training and consistency.

3 - Create your risk log

Create new risks, or import risks from your libraries. Associate risks with critical variables. Detail each risk with scores, review cycles, functional ownership and controls. Sort and filter your risk log for easy ongoing management.

OPRA RBQM Technology Software Risk Assessment and Management (RAM) module Risk Log
OPRA RBQM Technology Software Risk Assessment and Management (RAM) module Risk Dashboard
4 - Set up your risk dashboard

Each user can be assigned to one or more studies and manage all aspects of risk through the risk dashboard. Use the dashboard to focus on what’s important to you and use the dynamic linking to click through to detailed risk views.

5 - Risk management & evaluation

As your study progresses, risks will change and actions will be taken. Re-score risks as needed and see historic trends as risk levels change. Record decisions, manage and monitor changes in our fully auditable system. 

OPRA RBQM Technology Software Risk Assessment and Management (RAM) module Risk Management Screen
OPRA RBQM Technology Software Risk Assessment and Management (RAM) module Portfolio Overview Screen
6 - Portfolio overview

Set up your portfolio overview to identify your high-risk studies and manage compliance. With visibility across your portfolio you will be able to assess the status of each risk assessment and identify where risk reviews are overdue and where SOPs are not being followed.

7 - One-click reporting

OPRA 5 has a comprehensive reporting suite for ongoing risk management, CRO and Sponsor collaboration, and inclusion in the Trial Master File. All reports are timestamped and stored  for a full history of risk assessment and risk management over time.

OPRA RBQM Technology Software Risk Assessment and Management (RAM) module  Report Management bespoke and standard reports

Eight steps to Central Monitoring
success with OPRA

OPRA RBQM Technology Software Central Monitoring Module Organization Admin Page
1 - Set up your organization & studies

Create roles, users, authorizations and permissions based on individual studies or whole organizations. You can also authorize specific access for your external stakeholders.

 
2 - Set up your study dashboard

Choose the data you want to manage (based on your risk assessment) and how you want to manage it. Choose the data sets, visualisation types and statistical models for KRIs, KPIs and QTLs, and screen layouts to create your own dashboards. 

OPRA RBQM Technology Software Central Monitoring Module Study Dashboard Screen
OPRA RBQM Technology Software Central Monitoring Module Study Summary Scren
3 - Set up your study summary

Create a study summary for ongoing study reviews and high-risk site identification. Define additional information for risk level comparisons, such as site demographics.

4 - Drill down into the data

Root cause analysis paths ensure drill-down data is available at the click of a button, showing you where your risks are occurring and why. Use drill-down visualizations and data review tables to dive into site and patient level data. Data querying, sorting and filtering tools give you the view of data most helpful to you.

OPRA RBQM Technology Software Central Monitoring Module Key Performance Indicator KPI and Key Risk Indicator KRI Drill Down
OPRA RBQM Technology Software Central Monitoring Module Site Dashboard
5 - Set up your site dashboard

Create site dashboards to review individual site and site subject data. How you review site and patient level data may vary from higher level risk indicators and so different statistical models and visualization types can be utilized.

6 - Site overviews

Site overview screens enable you to track and analyze trends at the site level. You don’t just want to know what’s happening today, but what’s the direction of travel and where you should be focusing your attention.

OPRA RBQM Technology Software Central Monitoring Module Site Overview Screen
OPRA RBQM Technology Software Central Monitoring Module Closed Loop Screen
7 - Closed loop activity management

Create central review observations and actions. Assign actions to study team members, and manage those actions through to completion. Closed loop activity management gives you quality management activity tracking and a complete audit trail of all activities.

8 - Central Monitoring reporting

OPRA comes with a comprehensive suite of standard central monitoring reports to report on all quality management activity and indicators at a site level and across a whole study. 

OPRA RBQM Technology Software Central Monitoring Module  Reoprting Screen

OPRA 5

OPRA 5 is the latest version of our product. We invested 12 months of effort to make it the best RBQM platform on the market.

Find out what we've done and why in this short video from Duncan Hall, Founder & CEO of TRI.

You've now seen how easy OPRA is to configure for your organization, studies and sites, and the power of the data visualizations, monitoring and reporting tools. 
 
Find out how OPRA can deliver end-to-end quality management on your studies. Click the button below and ask for a demo.

Find out how we ensure your RBQM implementation is successful