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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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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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EMA Announce Adoption Date for ICH E6 (R2)

As seen with ICH E6 (R1), the EMA have led the way, becoming the first to adopt. For convenience, we have added the adopted guidance document to our resources page: ICH E6 (R2) EMA Adopted Guidelines So, after a long year of discussion and delays in 2016, 2017 is going to be the year we really start to see…

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Central Monitor Job Description

The role of the central monitor On the 17th November 2016, the ICH Assembly reported that they had adopted the important amendment, ICH E6 (R2) that aims to encourage sponsor to implement improved oversight and management of clinical trials and that the amendment would now be implemented by ICH members through national and regional guidance.   (http://www.ich.org/ichnews/press-releases/view/article/ich-assembly-osaka-japan-november-2016.html). While we wait…

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ICH E6 Revision 2 Approved

First new regulatory Members of ICH, key global good clinical practice guideline revisions agreed The International Council for Harmonisation (ICH) met in Osaka, Japan on 5-10 November 2016. As part of the objective to extend its global outreach, ICH is pleased to welcome the Agência Nacional de Vigilância Sanitária (ANVISA) from Brazil and the Ministry of Food and Drug…

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Industry Survey on ICH GCP E6 Rev 2 Readiness

Getting 67 companies to respond to a survey is no mean feat in itself, and whilst not a comprehensive measure of the current state of readiness, we feel it is a relevant enough sample size to be indicative of the industry in general. What do the results indicate? Firstly, it is encouraging that awareness levels seem to be really high, and…

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Press Release – TRI become the first MCC Solution Provider

Following a long standing working relationship between Triumph Research Intelligence (TRI) and the Metrics Champion Consortium (MCC), TRI will now make the IP developed by the MCC’s Risk Management working group available as part of the risk assessment and management module in their OPRA platform. The need for a centralized, easy to use, auditable protocol risk assessment and management…

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Press Release – Advanced Clinical selects TRI and OPRA for risk-based monitoring

Following a six month long industry wide technology assessment, Advanced Clinical, (Advanced) has selected Triumph Research Intelligence (TRI) as their RBM technology and services partner. TRI will be providing the OPRA platform for all of Advanced’s studies whose sponsors have requested a risk-based approach to monitoring with the objective of improving operational efficiency, quality, and patient safety. Conjointly, TRI…

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European Clinical Insights Press Release

TRI were delighted to take part in such a valuable set of meetings and have just been quoted in OmniComm’s recent press release regarding the event. TRI pride themselves on supporting the growth in uptake and understanding of risk-based monitoring within our industry and as such, events like these provide the perfect platform to understand the needs and challenges…

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TRI complete second round of funding

Raleigh, NC, July 20th 2015 – TRI, the risk-based monitoring company, is very excited to announce the completion of their second round of funding, and the furthering of its partnership with Peter Brummitt and Bev Mehentee, co-founders of Wider Perspectives Ltd. TRI is enjoying ongoing and rapid growth thanks to strong market demand both for OPRA, the risk-based monitoring…

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OPRA, the RBM platform: Autumn demo schedule

Each demo will be a 30 min live presentation which will cover the fundamentals of TRI’s four pillars of risk-based monitoring: Identify, Manage, Mitigate and Report (on site quality risk). Please follow the link to register for any of the demos: OPRA demo registration

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TRI releases OPRA Evolution 4

First – a little bit of background: TRI are committed to ensuring OPRA is the most up to date, usable and fully featured RBM platform available. In order to achieve this we need to do three things. 1 – listen to our customers – what do you like? what do you want to improve? what do you want to…

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