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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

12 April
eLearning R2 Awareness Training

The fastest and most cost effective way to understand what ICH E6 (R2) is, why it is…

10 April
Webinar: ICH E6 (R2): Training and Certification

May 3, 9:30am – 11:00am ET This webinar is a comprehensive review of the changes included in…

20 March
Webinar: ICH E6 (R2): A Practical Guide to Risk Assessment, Evaluation and Implementing Risk Controls

April 10, 9:00am – 11:30am ET Protocol Risk Assessment is the genesis of the new Quality Management…

19 March
Case Study: Use of OPRA to Identify and Manage High Risk Sites

Our client, a mid sized North American CRO was undertaking a large, global study for a key…