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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

10 July
FAQ 2 : What would be an example of a risk control at an organizational level?

This is typically a change at a procedural level, similar to CAPA, putting preventative measures in place…

10 July
FAQ 1 : What’s the difference between QTLs and risk indicator/thresholds

Quality Tolerance Limits (QTLs) are set at a study/protocol level and are typically a sub-set of the…

10 July
Worried about R2 compliance?

July 12, 10:00am EDT / 4:00pm BST Our free webinar will give you the information you need…

19 June
R2 survey results June 2018

Only 12% of companies reporting R2 readiness In June this year we conducted an industry survey on…