RBQM for Clinical Trials Made Simple.
Stay Compliant, Stay Competitive.

Powerful and Effective RBQM

At TRI, we make Risk-Based Quality Management simple and effective, helping sponsors and CROs cut down on manual work, and achieve better clinical outcomes with confidence.

Focus

Gain deeper insights and make faster, smarter decisions, that let you analyze from every angle.

Confidence 

Confidently shift to data-driven decisions with adaptive insights that evolve as your trial progresses.

Efficiency 

Reduce monitoring costs by up to 30%, allowing your team to focus on what matters most, patient safety.

Your Path to Clinical Compliance

See how our expertise in risk-based strategies empowers your team to cut costs, stay compliant, and deliver better clinical outcomes.

OPRA Centralized Monitoring

Cut Through Complexity

Focus on Critical Signals

Stay Ahead of Risk

Confident Decision-Making

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OPRA Risk Assessment & Management

Work More Efficiently

Stay Compliant

Focussed Resources

Confident Decision-Making

OPRA Subject Monitoring

Time‑Aligned Subject View

Built‑In Audit Trail

Role‑Based Access Control

Easily Compare Subjects

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TRI e-Learning

Good Clinical Practice

Learn the principles of Good Clinical Practice, key responsibilities for IRBs and Sponsors, and how RBQM strengthens compliance.

ICH E8 (R1)

Master the fundamentals of clinical trial design, conduct, and reporting with our comprehensive GCP e-learning course.

Risk Assessment and Controls

Explore how RBQM strengthens clinical trials by identifying critical data, evaluating risks, and improving decision-making.

Experts in RBQM

Crystal-clear Data Visualisation

Turn complex trial metrics into intuitive, actionable visuals.

Centralised Risk Management

Monitor, assess, and mitigate risks from one unified platform.

Smart Automation

Let OPRA handle the manual tasks, so your team can focus on strategy.

Efficiency gains of up to 30%

Streamline operations and reclaim time with intelligent trial oversight.

Trusted by 450+ Clinical Trials

Proven performance across hundreds of global studies.

Seamless Integration

OPRA fits effortlessly into your tech stack without disruption.

21 CFR Part 11 compliant

Built to meet the highest standards in clinical data integrity and security.

Built for all Trial Phases

Flexible, scalable, and ready to support your study from start to finish.

Explore key information about TRI

Choosing the right oversight partner demands precision and clarity. We tackle your most common questions head-on, equipping you with the insights you need to make confident, informed decisions.

Can your system record user comments queries or answers?
Yes. The system includes a built-in management tool called the Central Monitoring Toolkit. It lets users record comments and actions related to the study, a site, or the data in charts and tables. You can update this information any time. You can also view it in standard reports or export it to Excel.
Yes. You can assign observations and actions to individual users, tams or both. The system also alerts users when it assigns new actions to them.
Yes. The platform uses tailored data charts and statistical models for each clinical trial. These tools help spot patterns, trends and data issues. The systems design makes it easy to view and act on these insights.
Yes. Each KRI or KPI on the Study Hub lets you click through to more detailed data. You can filter this view to focus on subjects, visits, assessments, or even specific data points. This drill-down feature is key for strong centralized monitoring and risk based quality management.

OPRA supports all key RBQM processes for clinical trials, as defined in ICH E6 R3 and earlier guidelines. It enables sponsors and CROs to effectively manage quality and risk throughout the entire clinical trial lifecycle.


TRI works closely with leading groups like ACRO, PHUSE, and TransCelerate. We also learn from our user community and apply best practices in each platform update.

Yes. The system supports any number or type of KRIs, KPIs and QTLs. We offer a standard set to start with, and you can customize it based on your study or therapy area.

You can also create new data charts and indicators as needed. This makes the system flexible and effective for any risk assessment approach or RBQM for clinical trials.
We assign a full implementation team to each client. Support includes: 
  • Templates to simplify setup 
  • A sandbox area to test and review configurations 
  • A walkthrough of your custom setup 

We also train your system admins and super users. Online training videos are available before and after launch. Soon, we’ll add a support hub within the OPRA app for easy access to help content. 
Yes. We take data protection seriously. All TRI employees, contractors and partners must sign confidentiality or non-disclosure agreements before gaining system or data access.
TRI has delivered clinical trial tools since 2013. We launched our Centralized Monitoring service in 2016 and added our Risk Assessment and Management module in 2020.
Yes. OPRA works well with oncology studies because of their complexity and large data volume. Around 30% of our work has been in oncology.
Yes. The system handles changes. During setup, we include a wide range of Key Risk Indicators that give flexibility as the trial evolves. This makes it easier to manage modern complex clinical trials with strong risk-based quality management.

If you have further questions or want to chat with a member of our team, feel free to reach out to us directly.

9th July 2026

RBQM: Risked-Based Everything. Except the CRA

RBQM has transformed clinical trial oversight, but the CRA role has been left behind. In this free 30-minute live webinar, we set out a practical vision for what genuine risk-based monitoring looks like in practice.

RBQM Success Stories

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