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ICH E6 R2 Breakdown by Section

This ICH GCP Guideline Integrated Addendum Breakdown provides a quick overview of the unified standard for the European Union, Japan, the United States, Canada, and Switzerland to facilitate the mutual acceptance of data from clinical trials by the regulatory authorities in these jurisdictions. In the event of any conflict between the E6(R1) text and the E6(R2) addendum text, the…

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Datatrial and TRI announce tech tie up

Datatrial and TRI announce tech tie up The clinical trials industry is going through the biggest regulatory change in two decades, forcing companies that run trials to adopt a data driven approach and focus more on quality risk management. Dr Emma Banks, CEO of Datatrial based in northeast England said: “We are delighted to announce Datatrial’s technology partnership with TRI. We…

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Advance Clinical RBM Implementation

Our client, Advanced Clinical a successful, forward looking CRO who were seeing increasing demand from sponsors to offer quality oversight and central monitoring in accordance with the incoming ICH E6 (R2) guidance. Advanced Clinical wanted to ensure they had both the processes and technology needed to be able to offer and articulate this capability as part of any future…

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TRI nominated for the 2016 Metrics Champion Consortium(MCC) Champion award

TRI has been selected as a member of this year’s group of MCC Champions – a special honor bestowed upon individuals who made significant contributions in 2016 to advancing the MCC mission to improve the efficiency, quality and effectiveness of clinical trials. As the Metrics Champion Consortium (MCC) passes its ten year anniversary, the original mission has stayed the…

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The maturing of RBM implementation

As we at TRI continue to engage with industry on RBM implementation, I am pleased with the observations that we are currently making across a range of CRO and Pharma companies. Rolling back the clock 18-24 months and most of the discussions we were having with customers and prospects were about risk detection, data visualisation and stats models. For…

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Operationalizing RBM – Free RBM webinar

(Expired) Successful risk-based monitoring extends well beyond just risk detection. The clinical R&D industry needs to deliver on the promise of quality improvement and cost reduction both operationally and from a regulatory perspective.  We must be able to show evidence that due planning and oversight has taken place during a study by building an audit trail of the way…

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OPRA – A practical RBM demonstration

(Expired) This webinar will give a brief summary of the concept and purpose of the OPRA RBM platform, followed by a detailed system demonstration of the features and functions. We will wrap up with an open question and answer session, where you will be able to address questions to TRI’s management team. Please follow the link below to register…

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OPRA – technology walk through and latest features

(Expired) Learn how OPRA has been designed to support the four pillars of RBM: Identify, Manage, Mitigate and Report. See the new features in the latest evolution of OPRA, and learn how TRI are continually improving the system in order to support any company wishing to benefit from quality oversight and risk-based monitoring. Who should attend: Existing customers of…

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Protocol Risk Assessment and Designing Site Quality Risk Indicators

(Expired) Within this webinar, we will: – Illustrate the process of using the outputs of protocol risk assessment to identify protocol risk indicators – Illustrate the process of designing protocol risk indicators – Explore the characteristics of good indicators of site quality risk – Explore the practical application of surrogate risk indicators in RBM

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Free Webinar – ICH GCP E6 Revision 2

(Expired) ICH GCP E6 revision 2 is due to be finalized this summer and implemented later this year. The impact on any company running clinical trials is going to be significant. Companies need to start planning now to ensure adequate time for change management and implementation to occur. This free webinar, focusing on quality management, will allow companies to quickly…

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TRI Position Paper – Designing Risk Metrics 22Oct2013

1. Background Triumph Research Intelligence (TRI) was founded as a subsidiary of Triumph Consultancy Services in 2013, following 12 years of consulting to the clinical trial industry. Over the past 12 months TRI has been evaluating the specific challenges facing the industry when implementing a risk-based monitoring strategy and the various approaches and products being utilized by organizations as…

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OPRA Slide Presentations

Why? If a company wants to take a risk-based approach to monitoring, it must be able to prove it has a quality risk management plan which it executed, measured, and adjusted over time. How? TRI developed a purpose built application based on industry guidance that identifies site quality risk and allows central management of monitoring and risk mitigation activities What? OPRA…

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