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.
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.
We are so happy with the work your team have done – they have integrated into our team seamlessly and provide vital insight and domain knowledge.IT Director, Large Swiss Pharma
We 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…Operations Manager, Canadian CRO
I am a starter to RBM and it was absolutely very interesting to understand how RBM could work.Medical data reviewer, Large Pharma
Nice product. Respect to the teams work. I very much like it. In particular the design and items like trending, country level.Head of Innovations and Cross Functional Solutions, Large Pharma
I 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…CRA, Top 5 Large Pharma
Very 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…VP, Clinical Operations, Mid-Size CRO