COO’s Blog

What’s new and exciting in the Sector? April 15th 2019: We’re finally starting to get a readout from some of the regulatory agencies about their expectations around E6 (R2) and Risk-Based Monitoring. The FDA have recently released their draft Q&A document. We’re still getting a read-out on it, but on first glance it’s everything we’ve been saying around risk…

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TRI Webinar Channel

Go to our new webinar channel Over the last few years we’ve run over 25 different webinars to over 1,000 people. We often get requests for the recordings, so now we’ve made it easy for anyone and everyone to watch them.  There is a treasure trove of useful information, industry insights and great advice in there, so go ahead…

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Beyond Risk Assessment – what next?

Free Webinar – Thursday 30th May, 3pm BST In this free webinar, our COO Tammy Finnigan will pose the question “So you’ve done some risk assessment, what next”?  Lots of companies we talk to have started their R2 compliance journey, but over 80% of them say they’re “not there yet”.  Tammy will take you through some practical actions you…

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FDA RBM Q&A Guidance for Industry

In March 2019 the FDA released their RBM Q&A Guidance for Industry. If you haven’t read it yet, the link is below, it makes for some interesting reading. The focus of this guidance is to provide further clarification and suggestions on how best to implement risk based approaches to monitoring. Interestingly the guidance focuses very heavily on the risk…

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The R2 story – what is it, why it’s needed & why now?

Lots of people don’t understand what R2 is and why it’s needed. And unless you understand the fundamental reasons for its creation and adoption, it’s easy to dismiss it as ‘just more bureaucracy’.  But it isn’t.  It’s much more important than that, and here’s the reasons why. The way clinical trials are conducted has changed dramatically over the last…

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Steven Law is our new SVP of Sales

Steven Law has been appointed as the new SVP of Sales for TRI. Steven is a global sales leader with over 32 years of management experience within the IT software and services industry in sales, marketing and business development roles both directly and through channel partners. Over the past 25 years Steven has been working with some of the…

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Phil M’Caw new TRI CFO

Phil M’Caw has been appointed as the new Chief Financial Officer of TRI. Phil has over 25 years of hands-on experience of financial and commercial management in several sectors with growth businesses having international footprints. He trained as Chartered Accountant with KPMG London before moving into management consultancy with KPMG and then into roles in industry. He has worked…

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Mike Lewis announced as Chair of TRI

Mike is Chair of 4 public and private healthcare companies and has 30 years global Health industry experience having previously held senior roles at Align Technology (Amsterdam), Boston Scientific (Paris), C.R. Bard (USA), Sybron (Switzerland) and Becton Dickinson (UK) and was President of Gambro (Sweden) leading the £3bn buyout. Having spent 22 of the last 25 years living and…

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TRI raises multi-million growth funding

TRI raises multi-million growth funding from Octopus Investments to expand its Risk-Based Monitoring platform for clinical trials 15th October 2018, LONDON, UK – TRI, a leading global provider of Risk-Based Monitoring (RBM) solutions for clinical trials, has completed a growth capital fundraise to accelerate development of its core technology platform, OPRA and expand its international presence. Founded in 2014,…

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The best questions from 3 years of webinars and training

Over the past three years we’ve trained over 1,000 people in webinars, on-line training sessions and face-to-face sessions.  Most of that training has been done by Tammy Finnigan, our COO.  She’s the person ‘on the hook’ to answer when someone asks a difficult question.  Fortunately for us, she has a wealth of experience in Quality Management, Risk Based Monitoring,…

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Q&A 33 : How should known Risks be handled?

“How should known Risks be handled? Risks are always identified as potential facts right? I mean errors done with the ICF for example (as not timely approved by ECs although used) are already deviations, not risks.” ICH GCP Ref: 5.0 ; 5.0.2 I like to think of this using the simple worked example below. Fact: Known Information e.g. the…

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Q&A 32 : What if the risk is out of the CRO’s management/control?

“What if the risk is out of the CRO’s management/control, though still having probability & magnitude. As the budget assigned to sites for example?” ICH GCP Ref: 5.0 ; 5.0.1 – 5.0.7 ; 5.2.2 This is important from the CROs perspective. I think documenting the risk and agreeing the control mechanisms with the sponsor is critical in this scenario,…

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Q&A 31 : What is the responsibility if the CRO is in charge of drafting the protocol?

“What is the responsibility if the CRO is in charge of drafting the protocol?” ICH GCP Ref: 5.0 ; 5.0.1 – 5.0.7 ; 5.2.2 A risk assessment (ideally jointly with the sponsor) should be conducted, beginning with evaluating what is critical and identifying/evaluating the risk around it, where possible agreeing risk reduction/elimination with the sponsor and if not, then…

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