OPRA Central Monitoring
- Quickly identify critical risks by uncovering hidden insights
- Full visibility with intelligent, dynamic data structures
- Streamlined periodical review cycles
Let’s Empower RBQM Excellence Together, in Philadelphia
What You'll Discover
OPRA RAM
- One place to manage all risks, controls, and actions
- Assess effectiveness of controls by tracking trends over time
- Clear dashboards make oversight easy and consistent
ICH E6 R3 Compliance
The new guidance demands smarter, risk-driven trial oversight. TRI’s OPRA platform is built to meet these expectations, supporting principle-based, data-enabled decision-making across every phase.
Centralized monitoring, reimagined
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Instant Focus on Critical Risks
Automatically surfaces what matters most, no more manual data sifting. -
Confidence in Decision-Making
Clear, data-backed insights empower timely and informed actions. -
Efficiency Gains of Up to 30%
Streamlined workflows and reduced monitoring overhead.
We’re excited to connect with you at the RBQM Summit in 2026! Whether you're just starting your RBQM journey or looking to optimise your approach, our team is here to guide you toward smarter, more efficient trials.
Let’s talk about how TRI can support your goals with confidence and clarity.
Want to learn more beyond the RBQM Summit?
We'd like to offer you a trial of our new GCP e-Learning module, including ICH E6(R3) updates.
Simply hit the Register Now button below, and we'll set you up.
What you’ll learn:
- What ICH GCP is, and how it's structured in E6(R3)
- The 11 Core Principles of GCP
- How to manage Quality: RBQM
- What is Data Governance, and why it's important
Why TRI?
TRI are experts in Risk-Based Quality Management, with deep expertise and a proven platform designed to simplify compliance and accelerate clinical trial outcomes.
Whether you're preparing for ICH E6 R3 or looking to streamline your clinical operations, TRI has the experience, technology, and insight to help.
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Frequently asked questions
How long have you provided centralized monitoring for clinical trials?
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.
What support do you provide for onboarding and ongoing training?
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.
Can your system detect trends, outliers, or unusual data automatically?
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.
How does your system meet regulatory guidelines like ICH E6 R3?
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.