Centralized Monitoring

Made Simple

Elevate your trial oversight with OPRA Centralized Monitoring (CM): real-time insights, proactive risk management, and cost efficiency, all in one. Ready for a smarter approach? Welcome to OPRA-CM.

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About OPRA CM

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ABOUT OPRA

Centralized monitoring, reimagined

Dive into OPRA Centralized Monitoring (CM), where we're not just following the old playbook of clinical trial monitoring; we're reinventing it. Traditional methods keep you guessing until the next site visit, but with OPRA-CM, you're in the know. It's about zeroing in on what really matters: catching risks early, safeguarding study integrity, and saying goodbye to those surprise costs that traditional monitoring loves to throw your way. Designed for today's trials, no matter their size, phase, or location, OPRA-CM ensures your operations are smooth and your clinical trials are on track. Ready to step up your game and move away from the old school? OPRA-CM is here to make it happen.

Built with simplicity in mind

Harness the power of simplicity with OPRA-CM's intuitive centralized monitoring interface. We believe in making centralized monitoring straightforward, so you can navigate the complexities of your trial's risk landscape with ease and confidence. Our platform is designed to empower your team, providing clear, actionable insights without the need for specialized data science skills. Experience the freedom to focus on what truly matters in your trial, with the peace of mind that comes from having a user-friendly tool at your fingertips. With OPRA-CM, understanding and managing trial risks becomes second nature, allowing you to make informed decisions swiftly and efficiently.

Aggregate data from any source

OPRA-CM effortlessly pulls together data from any source, streamlining your centralized monitoring workflow. From lab results and wearable tech to patient records, we integrate it all seamlessly. This cloud foundation means you get a comprehensive view of your trial, free from the clutter of multiple systems. With OPRA-CM, your data is accessible, clear, and ready to use, wherever you are.

KRI, QTL and KPI libraries

OPRA-CM unlocks the power of data with its extensive library of pre-defined KRIs (Key Risk Indicators), KPIs (Key Performance Indicators), QTLs (Quality Tolerance Limits), and data table visualizations. This rich resource is at your disposal to instantly enhance your centralized monitoring strategy with proven metrics and views. OPRA-CM also offers the flexibility to create study specific KRIs, KPIs, and QTLs tailored to the unique needs of your trial. This blend of ready-to-use and customizable options ensures that your monitoring approach is always aligned with your trial objectives, providing clear, actionable insights that drive success.

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ABOUT OPRA

Centralized monitoring insights your way

Dive into a rich library of visualizations and craft bespoke dashboards tailored to your needs. Our platform puts the power of customization at your fingertips, enabling you to visualize your trial data exactly how you want it. Choose from a variety of charts, graphs, funnel plots and heat maps to bring your data to life and arrange them on your dashboard for a personalized view. This flexibility allows you to highlight the insights that matter most to you and your team, making complex information easy to understand and act upon.

Aids root cause analysis

OPRA-CM equips you with the tools to pinpoint problems, spot trends, and identify outliers at a glance. Beyond surface insights, our platform enables deep dives into data tables for comprehensive root cause analysis. Whether you're examining study-wide patterns, site-specific issues, or subject-level details, OPRA-CM provides the granularity needed for thorough investigation. This level of detail empowers you to understand the 'why' behind the data, ensuring informed decisions and proactive problem-solving. With OPRA-CM, every layer of your trial data is accessible, allowing for precise analysis and strategic planning.

Operations and activity management

With OPRA-CM, your study team can go beyond mere data analysis by actively adding central review observations and follow up activities directly within the platform. This feature enables a collaborative approach to issue resolution, where insights are not just noted but become actionable. Activities can be managed collaboratively within the platform, or emailed to activity owners directly from the platform. This streamlined process of observation and activity assignment fosters a proactive environment, where team accountability and efficiency are paramount, ensuring that nothing falls through the cracks.

Risk evolution tracking

OPRA-CM excels in trend analysis, giving you a clear view of how your trial risk is evolving over time. Understanding how site risk is changing over time, rather than a point in time analysis is key to driving adaptive monitoring and knowing where to focus your resources.

OPRA-CM doesn't stop at highlighting areas of concern; it digs deeper to reveal the underlying causes of risk. This level of insight enables you to not just see the what, but understand the why, facilitating informed decision-making and targeted interventions.

By focusing on trend analysis, OPRA-CM ensures you're always ahead of the curve, ready to address potential issues before they escalate. It's not just monitoring; it's strategic oversight, powered by data-driven insights that pave the way for a smoother, more successful trial.

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Reporting

H2

Feature

Unlock seamless risk communication with OPRA RAM's Advanced Reporting Capabilities. This feature is designed to streamline the way you share and communicate risk information, eradicating the complexities associated with traditional document sharing. With options for generating PDFs and bespoke reports, OPRA RAM ensures that you can tailor your risk communication to meet the specific needs of your stakeholders. These advanced reporting tools not only enhance clarity and understanding but also facilitate a more efficient exchange of critical risk-related data.

Feature

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Clinical trial risk management tools

Data Visualization Tools

OPRA CM

Real-time insights

Availability of up-to-date risk scores

Trend analysis

View evolution of risks over time

Collaboration

Centralized portal to collaborate with stakeholders

Alerts

Customizable alerts

Data visualizations

Customizable data visualizations

Version control

Eradicates duplication

Assign actions

Assign actions to stakeholders

Document corrective actions

Document key information

Audit ready

Full discoverability of mitigations after closeout

FAQs

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!