RBQM Risk Assessment Risk Management Central Monitoring Quality Tolerance Limits Site Management

Made Simple

TRI's platform makes RBQM simple for all clinical trials. Think less complexity, more clarity. Think less spreadsheets, more innovation. Think OPRA.

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About OPRA

Risk Assessment

Centralized Monitoring

ABOUT OPRA

OPRA, Pioneering RBQM for Clinical Trial Excellence

Meet OPRA, TRI's Risk-Based Quality Management (RBQM) platform. The most flexible, yet easy to use RBQM platform on the market. Featuring three core modules: OPRA-RAM, OPRA-CM, and OPRA-SM—used individually or in combination to meet the needs of each trial. OPRA revolutionizes RBQM with a comprehensive, systematic, and GCP-aligned approach. Whether you are just starting out or seeking advanced capabilities, OPRA will simplify RBQM for your clinical trials, improving trial integrity, efficiency and patient safety. Seamlessly integrating risk management throughout the trial lifecycle, and powered by advanced statistics and analytics, OPRA facilitates collaboration, decision-making, and the overall operationalization of RBQM.

Deployed on over 400 clinical trials
Secure, Validated, 21 CFR part 11 compliant
Designed for Sponsors and CROs running all trial phases

Our solutions

RISK ASSESSMENT AND MANAGEMENT

Empowering trials with OPRA, the future of RBQM

OPRA-RAM is the ultimate clinical trial risk management tool, enabling quality to be designed in and managed throughout the lifecycle of the trial. Drawing inspiration from the foundational principles of ICH E6 and E8, OPRA-RAM is meticulously designed to meet the requirements of GCP whilst providing an operational user experience which delivers clear, actionable insights. This is not merely about mitigating risks; it's about pioneering a transformative journey towards integrated quality, ensuring that every facet of your trial is aligned with the pinnacle of clinical excellence.

End to end quality and risk management
Strategic monitoring planning
Collaboration, activity management and reporting

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CENTRALIZED MONITORING

Where innovation simplifies RBQM complexity

With OPRA-CM, the playbook for clinical trial monitoring is completely reimagined. Designed by Clinical Operations experts OPRA-CM provides a platform which is tailored to the specific needs of each clinical trial. This ensures laser-focus on what truly counts: proactively identifying and mitigating risks, ensuring the integrity of your study, and eliminating the burdens often associated with conventional monitoring methods. Tailored to meet the demands of modern trials, regardless of their scale, phase, location, OPRA-CM provides a smarter approach to quality management, where every decision is based on evidence.

Tailored for each individual trial
Easy to interpret insights
Collaboration, activity management and reporting

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SUBJECT MONITORING

Subject Monitoring Precision in RBQM

In early phase trials, the ability to oversee the safety and progress of each patient is paramount. OPRA-SM is designed to idenitify and manage patient risk, where traditional site-based Central Monitoring approaches don't work. Medical monitoring of patient data can be inefficient and error-prone, but those problems go away with OPRA-SM's unique views on data changes and patient journeys.

Enhanced patient safety
Improved data integrity
Greater operational efficiency

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Compare OPRA

to traditional monitoring solutions

Traditional Monitoring

OPRA-CM

Proactive

Proactively identifies and addresses risks throughout the trial, preventing issues before they occur.

Comprehensive

Takes a holistic approach, considering risks across the entire trial, from protocol design to data analysis.

Data-Driven

Relies on data and analytics to make informed decisions about risk mitigation.

Flexible

Adapts to changes and unforeseen circumstances, maintaining quality in trials.

Adaptable

Allows for tailored risk assessments and mitigation strategies based on trial-specific factors.

Transparent

Promotes transparency by documenting risk assessments, mitigation plans, and decision-making processes.

Frequently asked questions

We've got the answer

Explore our FAQs for answers and expert advice on RBQM.

What is RBQM in clinical research?

Yes, you can try us for free for 30 days. If you want, we'll provide you with a free 30-minute onboarding call to get you up and running.

What is the difference between RBM and RBQM?

Of course you can! Our pricing scales with your company. Chat to our friendly team to find a solution that works for you as you grow.

What is the difference between RBM and RBQM?

Of course you can! Our pricing scales with your company. Chat to our friendly team to find a solution that works for you as you grow.

What is RBQM in clinical research?

Yes, you can try us for free for 30 days. If you want, we'll provide you with a free 30-minute onboarding call to get you up and running.

What is the difference between RBM and RBQM?

Of course you can! Our pricing scales with your company. Chat to our friendly team to find a solution that works for you as you grow.

What is the difference between RBM and RBQM?

Of course you can! Our pricing scales with your company. Chat to our friendly team to find a solution that works for you as you grow.

TESTIMONIALS

RBQM Success Stories

Hear directly from our partners about how we've helped them.

Peter Benton President & CEO, Worldwide

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.

Jeff Smith Former CEO, Alimentiv

What truly set TriTrials apart from other vendors was their unparalleled commitment to a quality deliverable helping us effectively apply a novel approach to our operations. They achieved a deep understanding of our objectives by partnering with us on a rigorous change management process which culminated in a shared vision for the integration of their risk assessment and central monitoring solution.

Amandeep Sonik Senior Director, RBQM, Worldwide

The Worldwide Clinical Trials team is pleased with our continued partnership with TRI and we are excited about the milestone of having 150 clinical trials in TRI's Risk-Based Quality Management platform. This is a key benefit for our customers as it improves data quality, trial efficiency, and patient safety.

Kelly Parish Holladay AD, RBQM, Worldwide

It has been such a wonderful ride with our TRI partners over the last few years developing our RBQM strategy with our Sponsors and Worldwide Clinical Trials Teams! We love working with everyone at TRI and look forward to bigger and better things to come!