Resources

KLIFO / TRI RBM Masterclass – 5th March Copenhagen

Join KLIFO and TRI’s masterclass in Risk-Based Monitoring and ICH E6 (R2) Compliance –       5th March. Copenhagen This is an important event because ICH E6 (R2) GCP regulations explicitly require a risk-based approach to quality management. However, in our experience, the challenges faced by small and mid-sized research organisations in effectively adopting Risk-Based Monitoring (RBM) and ensuring…

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Protocol Risk Assessment made simple – free webinar Feb 26th

Protocol Risk Assessments aren’t optional. ICH E6 (R2) GCP regulations explicitly require a risk-based approach to quality management and a key part of that is the protocol risk assessment. However, in our experience, the challenges faced by research organisations in effectively adopting Risk-Based Monitoring (RBM) and ensuring R2 compliance can be significant. For example. over 70% of the companies…

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Advanced Clinical / TRI Executive Roundtable Event

12th FEB 2019 |  THE BRADFIELD CENTRE Looking to maximise the value and benefits of Risk-Based Monitoring (RBM) within your organisation? This invitation-only event is for Pharmaceutical and BioTechs in the Cambridge area.  In the session you will learn practical RBM implementation strategies alongside RBM professionals hosted by experts from Advanced Clinical and TRI. If you are interested in…

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COO’s Blog

Removing resistance to RBM one protocol risk assessment at a time …   Jan 6th 2019:  In the last weeks of December I was heavily involved in facilitating protocol risk assessments for two very different prospects.  The first was a phase 1 paediatric study, where the risk assessment is being led by the sponsor and being initiated at the…

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Veristat partners with TRI

Veristat Partners with TRI to Provide Centralized and Risk-Based Monitoring Technology to Their Biopharmaceutical Clients Veristat, a full-service Clinical Research Organization (CRO), announced today that it has partnered with Triumph Research Intelligence (TRI), a global leader providing technology and solutions for centralized and risk-based monitoring (RBM) to improve clinical trial quality and compliance. Earlier this year, the US Food…

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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 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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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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