Clinical Quality Compliance
WELCOME TO TRI
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.
Expertise in Risked based Monitoring
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Welcome
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.
Latest News
The fastest and most cost effective way to understand what ICH E6 (R2) is, why it is… May 3, 9:30am – 11:00am ET This webinar is a comprehensive review of the changes included in… April 10, 9:00am – 11:30am ET Protocol Risk Assessment is the genesis of the new Quality Management… Our client, a mid sized North American CRO was undertaking a large, global study for a key…
eLearning R2 Awareness Training
Webinar: ICH E6 (R2): Training and Certification
Webinar: ICH E6 (R2): A Practical Guide to Risk Assessment, Evaluation and Implementing Risk Controls
Case Study: Use of OPRA to Identify and Manage High Risk Sites
Testimonials
I thoroughly enjoyed the training today. I have been worried about the updated guidelines and not really getting to grips with them, but today really highlighted what our team needs to focus on.
Thank you
Sr Director, Regulatory and Compliance, Large CROThank you very much to you and Tammy for organizing and performing this excellent webinar. It was very interesting and I learnt a lot.
Thank you
Head of Clinical Research, Large African-based CROThank you very much for delivering this very valuable training.
Thank you
Senior CRA, Poland-Based CROThanks for the webinar, I appreciated the extra detail you had that some others I’ve seen lacked!
Great where others lacked
CTO, Large UK-based CROWe are so happy with the work your team have done – they have integrated into our team seamlessly and provide vital insight and domain knowledge.
We need you
IT Director, Large Swiss PharmaWe really appreciate the level of organization and thought that you folks have put into the KRIs as it has pushed us to consider them within the context of need and value. We are…
Thank you!
Operations Manager, Canadian CROI am a starter to RBM and it was absolutely very interesting to understand how RBM could work.
Thanks for the excellent overview!
Medical data reviewer, Large PharmaNice product. Respect to the teams work. I very much like it. In particular the design and items like trending, country level.
Great Webinar
Head of Innovations and Cross Functional Solutions, Large PharmaI have to say, I’ve been on SO many web-based instructor led training but I’ve never attended one that was so interactive, easily understood, well explained and not boring! It didn’t feel like a…
Thank you!
CRA, Top 5 Large PharmaVery helpful! Thank you. An important part of our selection of OPRA was the RBM consulting service! We knew we needed a vendor that could lead and teach us so for that we are…