RBQM made simple
ICH E6 (R2) Section 5.0 defines Quality Management in seven "risk-based approaches". TRI delivers all seven through our tried and tested combination of technology, services and training, all delivered by Operational Experts.
WHAT WE DO
The all-new OPRA 5 has two powerful modules.
Risk Assessment & Management
Consultancy support from operational experts.
Protocol Risk Assessments,
Integrated Strategic Monitoring Plans and Change Management
Manage your trial risks, from up-front Protocol Risk Assessment right the way through to inspection ready reporting, with OPRA RAM. Fully compliant with ICH E6 5.0 Quality Management, it's easy to set up and tailor for your organization. It's the most advanced risk management tool available today.
See your most important study, site and subject data in one place. Use combinations of statistical models to drill down into the poorest performing sites. Review trends and outliers to identify problems and intervene early. Quickly and easily create inspection-ready reports.
Successful implementation of RBQM takes more than just great software. It needs help, guidance and support from operational experts who've done it before. Find out more about the way we do it. It's people 1st, process 2nd, technology 3rd.
Created by our operational experts, our Good Clinical Practice (GCP) and Risk Assessment & Controls e-learning modules are quick, easy and cost-effective to deploy. Free trial for Sponsors and CROs.
TRI is the industry leading provider of Risk-Based Quality Management (RBQM) solutions for clinical trials.
Based in Cambridge, UK, and Raleigh, North Carolina, USA, TRI was founded in 2013 by CEO Duncan Hall with the specific aim of making RBQM simple and accessible for all clinical trials.
Building trust in a virtual world
You’re probably thinking “What’s trust got to do with Risk-Based Quality Management?”
The answer is simple. Implementing RBQM affects every part of your business, and that’s not something anyone should undertake lightly.
If you’re going to do it, do it right first time and pick the right partner. A partner you can trust.
You can’t just Google for RBQM software, click buy, and away you go. If you do, you'll fail because it’s much more complex than that.
Implementing RBQM and a Risk Based Monitoring (RBM) approach changes every part of your business, including SOPs, training, roles, responsibilities, technology, operations, business models and cost structures. That’s why you need expert help.
But how do we build trust when all the ‘old world’ ways, such as meeting face-to-face, eyeballing someone while they talk, building rapport over coffee or dinner, and shaking hands on a deal, have all been taken away?
Click here to find out some of the ways we're building trust with people we know, and just as importantly, those who we don’t know (yet).