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Veeva R&D Summit Boston 2025

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1Duncan Circle

CEO
and Founder

1Steve Circle

Senior Director
Business Development

1Lamek Circle

Business Development
Specialist

Let's Connect at the Summit

We can’t wait to meet you in Boston and support your journey toward smarter, more efficient trials. We’re here to help you navigate RBQM with confidence. Click the button below to schedule a meeting with our team

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What You'll Discover

OPRA Central Monitoring

Transform oversight with real-time insights and streamlined workflows. OPRA-CM empowers teams to cut through complexity, focus on critical signals, and take confident, data-driven action.

OPRA RAM

Quickly identify, assess, and manage trial risks in one intuitive platform. OPRA-RAM centralizes all risk-related activities, helping teams prioritize what matters, track trends over time, and demonstrate proactive compliance

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.

Want to learn more beyond the Summit? Join Our ICH E6 R3 Webinar

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Join us for a high-impact webinar, featuring expert insights from industry leading speakers, exploring how ICH E6(R3) is reshaping clinical trial oversight, and how Risk-Based Quality Management (RBQM) is the key to unlocking smarter, more resilient trials.

What you’ll learn:

  • Key differences between ICH E6(R2) and R3
  • How CROs are adapting to new expectations
  • Top challenges in implementing R3 and how to overcome them
  • Practical strategies for sponsors, CROs, and compliance teams to thrive in the new regulatory landscape
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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.


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.