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We're the Risk-Based Quality Management experts because we only do one thing -
RBQM solutions

The 3 big benefits of RBQM are better data quality, increased patient safety, and reduced monitoring costs. But implementing RBQM solutions can be hard. Developing in-house tools, training and processes is time-consuming and expensive. And there's a shortage of trained and experienced people.
Let us help speed things up so that you get to the benefits faster.

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Worldwide Clinical Trials www.worldwide.com.w

“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.

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. 

ICH E6(R2) Quality Management Process Steps

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

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.

Tools

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

Gap

Analysis

Compliance

Pack

Training

Quick, easy, effective

e-learning modules for all your staff.

Good Clinical

Practice

Risk Assessment

& Controls

Consultancy

Learn from Operational experts to develop your own skills.

Protocol Risk Assessments

Integrated Strategic Monitoring Plans

Resources

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

ICH E8(R1) webinar - what you need to know and practical implementation advice

Webinar

ICH E8(R1) - What you need to know and practical implementation advice

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Blog

What does RBQM Technology give me that my existing "free" systems don't?

Introduction to Risk-Based Quality Management (RBQM) Brochure

Brochure

Introduction to Risk-Based Quality Management

Contact Us

Want to know more? Please get in touch.