for all clinical trials
MAKING RBQM Simple
Intelligent software for people who care about quality.
Tools you'll LOVE because they make your job SO much easier.
Why? Because they're as simple to use as a spreadsheet but much more powerful. And they're built around YOUR processes and do all the hard work for YOU.
The outcome? Better trial quality, decision making and efficiency, resulting in safer patients and a happier team.
There are two modules, Risk Assessment & Management (RAM), and Central Monitoring (CM). They can be implemented together or separately. Unlike others, we won't make you buy something you don't want or need.
Smart software for better risk management.
Built for Operations, loved by Auditors.
Whether you’re a sponsor or CRO; whether you’re a Clinical Trial Manager running 10 studies, or a CRA needing to record a new Site risk; whatever your role in clinical trial management, you’ll love RAM because its ‘spreadsheet easy’, but way better.
We’re so confident that you’ll love it that we’ll give you a free three month trial. We'll get up and running to show you how easy it is, then you can play with it to your heart's content :-)
Simple menus take you straight to the information you need.
Total grip on all your risks with real-time data
Quickly and easily monitor risk trends over time
As easy to use as a spreadsheet - show your data your way
Simple software for better, faster decision making.
Built for Central Monitors, but so easy to use that anyone can spot outliers and drill down to find out what's going on in your study at the site and the subject level.
Take data from any source, select the visualization, set your thresholds and away you go. OPRA CM's biggest strength is its flexibility. Show your data, your way and use it to make better, faster decisions.
Review data at the study or site level
Hover over data points for more details
Create bespoke dashboards
Drill down into companion data for root cause analysis
Choose from over 40 standard visualizations including charts, funnel plots, and heat maps
Make your RBQM implementation simple and efficient with our ready-to-go, out-of-the-box SOPs, templates, and Job Descriptions. All created by our RBQM experts based on the experience of implementing RBQM for over 50 companies.
Get the RBQM training materials your staff need, saving you time, effort, and money. Simple and engaging, our one-hour e-learning modules, including interactive quizzes, testing, and certification, make administering all-staff training simple and efficient.
Risk-Based Quality Management (RBQM) is a methodology for ensuring that your clinical trial data is of the highest quality and integrity.
RBQM means proactively identifying, assessing, and managing your trial risks. It is recommended in the ICH E6(R3) and E8(R1) guidelines, and promoted by regulatory authorities such as the FDA and MHRA. RBQM also helps to reduce costs and improve trial efficiency.
But clinical trials are complex, expensive, and involve significant risks. That makes implementing RBQM challenging. Simplifying RBQM increases your chances of success.
TRI’s mission is to make RBQM simple for all clinical trials.
“It has been such a wonderful ride with our TRI partners over the last few years developing our RBQM strategy with our Sponsors and Worldwide Clinical Trials Teams! We love working with everyone at TRI and look forward to bigger and better things to come! 😎”
Kelly Parish Holladay, Associate Director, RBQM