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Webinar: ICH E6 (R2): Training and Certification

May 3, 9:30am – 11:00am ET This webinar is a comprehensive review of the changes included in revision 2 of the ICH E6 guidance. It is designed for anyone who is looking for a broad understanding of the changes, or is in the process of adopting the changes in readiness for compliance. Delivered by our in house expert, Tammy…

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Webinar: ICH E6 (R2): A Practical Guide to Risk Assessment, Evaluation and Implementing Risk Controls

April 10, 9:00am – 11:30am ET Protocol Risk Assessment is the genesis of the new Quality Management section (5) of ICH E6 (R2) and core to the principles of quality by design (QBD). It drives much of the downstream quality planning and management activity during the course of a clinical trial and yet it is something we find many…

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Webinar: ICH E6 (R2) Overview

March 27, 9:00am – 10:00am ET The session will highlight the key changes made in ICH GCP E6 (R2) which was implemented by the EMA on 14 Jun 2017 and added to the FDA guidance documents on 1 March 2018. This webinar is for anyone wanting a high level understanding of what R2 is, why it has been implemented…

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R2 Implementation and CRO Oversight Case Study

Our client, a large global biopharmaceutical company had recently merged with another similar company. The QA department of the resulting company was met with the task of both integrating two quality management systems as well as preparing for ICH E6 (R2). To add further complexity to their situation, our client was also looking to streamline the number of strategic…

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The Current State of ICH E6 Revision 2

In November 2017, one of the EMA’s Inspectors, Sophia Mylona, reiterated the importance of Revision 2 (R2) to the attendees at the 5th Global QA conference in Edinburgh, Scotland. Her message surprised the crowd. Not because ICH E6 (R2) is something new. On the contrary, this revision was finalized in November 2016 and put into effect by the EMA…

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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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