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
Only 12% of companies reporting R2 readiness In June this year we conducted an industry survey on… June 21, 10:00am EDT / 3:00pm BST Free webinar: OPRA – making quality management and R2 compliance… June 14, 10:00am EDT / 3:00pm BST Free Webinar: R2 readiness – A practical guide to protocol… June 7, 10:00am EDT / 3:00pm BST Everything you need to know about the key ICH GCP…
R2 survey results June 2018
Webinar: OPRA – technology that makes quality management and R2 compliance simple
Webinar: A practical guide managing protocol risks
Webinar: What you need to know about R2
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…