top of page


for all clinical trials

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 by the ICH and 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. Here’s how we do it for Sponsors and CROs…

20230227 OPRA RBQM Tech-20.jpg

Our intuitive SaaS platform supports all involved functions from Sponsors, CROs, and external vendors in managing data quality and risks. With everything in one platform, collaboration, operational management, and reporting are simple and central to your trial.

Access your current and historic risk information centrally across the enterprise. Easy to identify, assess, and monitor of all study risks and Critical to Quality (CtQ) factors. Risk, KRI and QTL libraries make risk assessment simple and efficient, driving consistency of approach across the enterprise.

OPRA Risk Log


Simple menus take you straight to the information you need.


Create bespoke risk scoring models for your studies

Quickly and easily monitor risk trends over time



Configure screens to show your data your way

View and analyse your data across any sources the way you want to view it. Whether that be simple and standardized or specific to the needs of a study or therapy area, OPRA allows you the ultimate flexibility. Our unique drill down and time based analysis allows you to not only understand where your risks are, but their likely root causes. Use our KRI and KPI libraries to quick start your Central Monitoring or develop your own. We can even support you through your first data review cycles to make sure you maximise the value of central and risk-based monitoring. 

OPRA Central Monitoring Dashboard


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.

20211207 Gap Analysis slide.PNG

We’ve created 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.