Duncan speaking at CBI RBM Conference, 13 Nov Philidelphia

CEO, Duncan Hall will be speaking at the CBI RBM conference on 13th November. The title of Duncan’s presentation is “Beyond Risk Assessment – What does effective Risk Management look like and how does this affect ongoing monitoring strategy?” During the session, Duncan will show delegates how to design a monitoring strategy to align with the risk assessment, and…

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Why a great Sponsor/CRO relationship is vital for RBQM – Free Webinar 31 Oct

E6 (R2) and E8 (R1) guidance require Sponsors and CROs to work together closer than ever before.  Understanding what each party wants and needs from that partnership is the key to Risk-Based Quality Management (RBQM) success, but can be challenging because people are still working out what it means in practice. There is a better, faster way than trial…

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Back by popular demand – Simplifying RBQM with Rachel Oakley – Free Webinar Thurs 21 Nov

We hear from lots of organisations that are struggling with implementing RBQM. In this free webinar, Rachel Oakley, VP RBQM Services, will debunk some of the myths about RBQM and share practical advice on where to start, what success looks like and how to create a monitoring strategy that really works. Rachel recently joined TRI from Syneos Health (Previously…

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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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Helping CROs sell more using TRI tools – Free webinar Thurs 14 Nov, 3pm BST

Interested in winning more studies? Want to give yourself an edge over the competition? In this free webinar Tim Collard, TRI VP of Sales, will show you how you can add more value to your customers and win more studies using our new Risk Assessment and Risk Management tool. As part of your bid process, conducting protocol risk assessments…

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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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