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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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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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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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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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Top 5 Challenges to ICH E6 Rev 2 Compliance

  Let’s look at the intent and purpose of the revision … The revised Addendum is proposed to modernize ICH E6 and enable implementation of innovative approaches to clinical trial design, conduct and management that will better ensure subject protection and data quality. This is a significant and positive step, but we will only realize the benefits if we…

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Setting Your Own Standards for ICH E6 Rev 2 Implementation

  The “eagerly awaited” revision to ICH E6 is going to provide a clear message about the expectation for how a clinical trial is conducted in today’s world compared to the world of the mid 1990’s when the first version was adopted by the three ICH regions. ICH E6 is by definition a guideline and therefore provides guidance, i.e….

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ICH E6 Revision 2 – What Does It Mean In Practical Terms?

Nowadays we all use multiple electronic systems in clinical trials. Consequently, we need SOPs in place to define/control how these are developed, used, accessed and secured to ensure of the integrity of the data we produce.   We’ve been doing corrective and preventive actions (CAPA) for years but Revision 2 emphasizes the need to analyse the “root-cause”…

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ICH E6 Revision 2 – “Begin With The End In Mind”

  Regulators will soon require sponsors and CROs to demonstrate that they have effectively anticipated, managed and mitigated risk during the course of each study.   Identifying and then setting your end point as the target is the most likely way to achieve success.  We have to know where we want to end up in order to plan and…

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Capability Maturity Model for Quality Management

What is a Capability Maturity Model? A capability maturity model (CMM) is a simple way to express an organisation’s capability in a defined area against a number of parameters. The traditional model offers five levels of maturity, typically defined as 1 – Initial, 2 – Managed, 3 – Defined, 4 – Managed, 5 – Optimized, as seen in the…

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What do you have in place for ICH E6 Rev 2, and what do you need?

How Can You Claim to Do Risk-Based Monitoring If You Don’t Know How Much Noise Is In Your System?   My last article was concerned with the overall lack of using available data and technology to make better decisions, which is endemic within industry as well as people’s personal lives. In fact, Conway’s Law would suggest that how individuals…

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Better risk-based thinking will help produce better risk-based monitoring

How People Can Get Better At Risk-Based Thinking and Improve Their Organization’s RBM Misinformation about risk based monitoring abounds. In fact, the level of misinformation on the topic long ago surpassed the level of correct information. I wanted to provide some practical insight as to why risk-based monitoring is so important to the work you do. There is a…

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Trial oversight in SMB Pharma – Reflections on 6th CQOF

Firstly, I wanted to say what a great event the CQOF was – well attended, well organised, great presentations and great dialogue. Well done Kristen and her team. There were a few more attendees than last year which is always positive, but a very different demographic and feel to the event. The focus on the relationship between trial oversight…

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Why is the funnel plot so important to risk-based monitoring?

Before I dive into some of the detail about funnel plots, I wanted to start by highlighting a few key concepts, driven by risk-based monitoring (RBM) which are likely to come into play, whatever your specific approach to RBM is going to be:   You want to start assessing site quality risk as early in the trial as possible,…

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