“Risk Controls – much more than just metrics” – Free KLIFO/TRI Education Workshop – 8th October, Copenhagen

There’s a lot of industry focus right now on risk indicators, but there are other, important ways to reduce your trial risks.  In this, the third in a series of free educational workshops on Risk-Based Quality Management from Klifo and TRI, you’ll get best practice and worked examples of different types of controls, both metric and non-metric. You’ll also…

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Duncan Hall speaking at the SCDM Annual Conference 30th September

Duncan will be speaking at the Society for Clinical Data Management (SCDM) annual conference in Baltimore on 30th September. He is one of the expert speakers discussing “The merging of Data Management and Clinical Operations – welcome to the future”. Senior leaders will discuss how process, methodology, and technology are breaking down the traditional silos of Data Management and…

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Duncan Hall’s notes from the MCC Summit

Duncan and two new members of the TRI team (Rachel Oakley, VP RBQM and Maureen Fosdick, VP Sales) attended the MCC Clinical Trial Risk and Performance Management Summit in Philadelphia on the 4th and 5th September.  Duncan was part of the panel session on Risk-Based Site Monitoring Emerging Practices, and facilitated one of the breakout discussions on ‘Keeping the…

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Duncan Hall’s feed-back from FDA presentation on Risk-Based Quality Management

July 19th, 2019: I’ve just got back from the FDA’s “Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations” event on Wednesday 17th. It was a truly great event, and well worth the trip over the pond! It was really exciting to see alignment between the regulatory authorities, the sponsors and CROs and a unanimous view that risk-based…

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Tammy Finnigan speaking at SCOPE Europe 2019 – Are you going?

Tammy Finnigan, TRI COO will be speaking at SCOPE Europe in September. Speaking on the first day in the Risk-Based Monitoring strand, she’ll sharing her knowledge and insights on critical topics such as: risk-based monitoring in E6 and E8; the impact RBM has on the changing role of the CRA; and industry collaboration around risks. We’ll be on booth…

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COO’s Blog

May 2019 In this video blog, Tammy talks about how Centralized Monitoring won’t solve all your Quality Management issues, the changing role of the CRA because of RBM, the first readout of the E8 (R1) guidance and much more… What’s new and exciting in the Sector? April 15th 2019: We’re finally starting to get a readout from some of…

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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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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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