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Clinical Quality Compliance


We are specialists in ICH E6 (R2) compliance, central and risk-based monitoring. We provide the technology, services and training required to improve patient safety, data quality and operational efficiency in clinical trials.


R2 compliance, central monitoring and RBM made simple! OPRA is the leading platform for anyone wishing to oversee quality,…

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Everything you need in order to achieve ICH E6 (R2) compliance, central and risk-based monitoring. TRI have now supported…

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At TRI we understand that successful implementation of ICH E6 (R2) and Risk-based monitoring is not just about processes…

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Who We Are

TRI was formed with the explicit vision of enabling companies to successfully adopt ICH E6 (R2) and the practice of central or risk-based monitoring through the provision of innovative technology, professional services and change management. TRI developed the first ever truly RBM focused technology—”OPRA”. OPRA is a cloud based, 21 CFR part 11 compliant, system for quality oversight, central and risk-based monitoring. OPRA is designed for anyone wishing to run their trials in a ICH E6 (R2) compliant manner and supports data integration with any EDC, CTMS or open data source.

With the recent adoption of ICH E6 (R2) in Europe and planned adoption for the FDA later this year, quality and risk management have never been more important or relevant to the way in which we conduct clinical trials. Learn how TRI is able to support sponsor clients in achieving R2 compliance through a risk-based monitoring approach.

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Latest News

22 September
Duncan at MCC Clinical Trial Risk and Performance Management Summit 14/15 Nov

Duncan Hall, TRI CEO, will be a panelist in the session on Risk Management Emerging Practices and the Impact…

30 August
ICR Project Management Forum 19th Oct

Tammy  Finnigan confirmed as expert speaker at the ICR Project Management Forum Held at Syneos Health, Farnborough…

23 July
Is your Sponsor/CRO partnership R2 ready? – Free Webinar 27th September

Register now to book your place. Is your CRO R2 ready? In our June survey of more…

22 July
The R2 story – what is it, why it’s needed & why now?

Lots of people don’t understand what R2 is and why it’s needed. And unless you understand the…