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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 and technology. Your capability and maturity as a firm is dependent on how effectively you mobilize your workforce.

Training needs range from an initial understanding of the new regulations, their rationale and how they will effect you, right through to a much deeper level of training on specific processes such as protocol risk assessment, and the creation of integrated quality plans. TRI have been helping companies prepare for and implement R2 and RBM for four years now and have a wealth of experience and content.

Whatever your firm's needs, and whether you prefer e-Learning, web based learning or classroom learning, we are confident we can help you.

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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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