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

We make Risk-Based Quality Management (RBQM) simple for all clinical trials.

Our Operational Platform for Risk Analysis (OPRA) gives you ICH E6(R2) compliant, end-to-end quality management. From identifying critical factors and risks before your trail starts; to risk assessment, monitoring and management; Central and Risk-Based Monitoring (RBM); through to one-click reporting at the end. All in one secure, easy to use platform that gives you better data quality, improved trial efficiency, and increased patient safety.

Let us help you get those benefits faster with our RBQM solutions today.

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Worldwide Clinical Trials partner with TRI

“Worldwide’s RBQM team is one of the most experienced CRO teams in the industry. This, coupled with TRI’s best-in-class technology, ensures we can proactively identify and manage risks, meaning improved quality and patient safety, and, in turn, provide a better experience for sponsors and patients.” 

Peter Benton, President and co-CEO

What sets us apart is our focus on Operations. We know from experience that a stats package or BI tool alone won't give you the RBQM benefits. That's because it doesn't help your Operational teams change the way they deliver clinical trials.

Our RBQM technology platform, OPRA, was designed by Operational experts to do just that. It drives a risk-based approach through a powerful and easy-to-use tool that, along with our training and support, ensures your RBQM implementation is successful.

ICH E6(R2) Quality Management Process Steps from TRI

End-to-end Quality Management

OPRA is an operational platform for managing every one of the seven E6(R2) Quality Management process steps.

It gives your team the tools they need to quickly and easily identify, evaluate, monitor, manage, and report on your critical clinical trial quality data. 

OPRA - RBQM Technology

OPRA has two modules: Risk Assessment & Management (RAM); and Central Monitoring (CM). They can be implemented separately, but together they give you the most powerful RBQM platform on the market.

OPRA Risk-Based Quality Management RBQM technology software from TRI

The E8(R1) E6(R3) Quality Continuum

OPRA creates a quality continuum between E8(R1) Quality Design and E6(R3) Quality Management by capturing data, information and lessons learned from current trials to support the design of new trials.

Helping you implement RBQM

We know that implementing RBQM is hard, so we've developed a range of services to help make it easier for you.


Support to identify your gaps and get you up and running quickly.






Quick, easy, effective

e-learning modules for all your staff.

Good Clinical


Risk Assessment

& Controls


Learn from Operational experts to develop your own skills.

Protocol Risk Assessments

Integrated Strategic Monitoring Plans


Free resources to help you and your team learn more about RBQM

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EMA implements E8(R1)

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Webinar Recording

E8(R1) - What You Need to Know and Practical Advice on How to Implement It

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5 Big Challenges for Tomorrow's Clinical Trials

Contact Us

Want to know more? Please get in touch.