Making RBQM SIMPLE
for ALL clinical trials
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.
OPRA is a fully validated, secure SaaS platform. There are two modules, Risk Assessment & Management (RAM), and Central Monitoring (CM). They can be implemented together or separately. A third module, Subject Monitoring will be released in 2024.
OPRA takes data from any source to create standard and study specific data visualizations.
-
E-Learning: awareness and leveling
-
Implementation plan
-
Scope / Phasing
-
Timeline
-
Budget
-
Resources & roles
-
Messaging
-
RBQM Approach (High level)
-
Process definition / updates
-
Training on new processes
-
Core KRI / KPI / QTL selection / definition
-
Technology implementation and integration
-
Technology training
-
Facilitated Risk Assessment
-
ISMP support
-
Central Monitoring review
-
Sponsor Meeting support
-
Ongoing technical and process support
-
Governance
Contact Us
Don't just take our word for it... here's what other say about us
“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
What is RBQM?
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.