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Worried about R2 compliance?

July 12, 10:00am EDT / 4:00pm BST Our free webinar will give you the information you need and practical advice on implementation. The session will highlight the key changes made to ICH GCP E6(R2). We’ll also share with you what’s important, what you need to know and some practical steps that you can take on your R2 compliance journey….

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R2 survey results June 2018

Only 12% of companies reporting R2 readiness In June this year we conducted an industry survey on ICH E6 (R2) readiness, and had over 100 responses.  Only 12 % said they have completed their readiness programs.  Even more surprising, 27% of respondents said they haven’t even started yet. Given the adoption of R2 by EMA, FDA and Health Canada…

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Webinar: OPRA – technology that makes quality management and R2 compliance simple

June 21, 10:00am EDT / 3:00pm BST Free webinar: OPRA – making quality management and R2 compliance simple       This webinar showcases TRI’s OPRA technology platform.  Learn how OPRA supports central monitoring, RBM, quality oversight and reporting. Understand what’s new in the latest release of OPRA and what’s upcoming in the next release.    To Register, click…

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Webinar: A practical guide managing protocol risks

June 14, 10:00am EDT / 3:00pm BST Free Webinar: R2 readiness – A practical guide to protocol risk assessment, evaluation and implementing risk controls. This webinar is designed to help anyone planning to conduct protocol risk assessment and develop a quality management plan as part of ICH E6 (R2) compliance. The session will describe the regulatory context from ICH…

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Webinar: What you need to know about R2

June 7, 10:00am EDT / 3:00pm BST Everything you need to know about the key ICH GCP E6 (R2) changes. It’s for anyone wanting know what R2 is, why it has been implemented and how it will impact your company. The impact of ICH E6 (R2) on any company running clinical trials is going to be significant. With most…

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eLearning R2 Awareness Training

The fastest and most cost effective way to understand what ICH E6 (R2) is, why it is so important, and what it means to your organization. This 90-minute course is available as a self-serve eLearning package, or an instructor led webinar. The course is targeted at individuals within Sponsor organizations and CROs that are involved in the design, conduct…

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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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