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Resources

Advanced Clinical and TRI to deliver RBM Round Table Event in San Francisco

Tuesday, May 9, 2017,    8:00am-11:00am,    Burlingame, Embassy Suites San Francisco, Airport-Waterfront   The implementation and operationalization of Risk-based monitoring is a challenge for any company. With ICH E6 (R2) being formally implemented this year, RBM is becoming an increasingly hot topic, and at the top of the strategic agenda of many sponsor organisations. Advanced Clinical implemented RBM using TRI’s…

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TRI to present at MCC’s Central Monitoring Working Group

TRI are part of the MCC’s solution provider program and are delighted to be working with the MCC in their central monitoring working group. During the presentation, Duncan will cover the following areas:   How KRIs and statistical models can be used in conjunction to provide the insight needed for informed decision making How data analytics can be used…

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Free Webinar – 7th Feb 2017 – Using technology to support ICH E6 (R2) compliance

The video below shows TRI’s CIO Chad Finch introducing the webinar: This webinar is free to attend for anyone who is directly involved in the planning and execution of clinical trials.   WHO SHOULD ATTEND? Anyone who is already running clinical trials using the principles of quality management  as defined by ICH E6 (R2) and risk-based monitoring,  or anyone…

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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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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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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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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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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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TRI and Wider Perspectives Partner on ICH GCP E6 Rev 2

As the implementation of ICH GCP E6 Rev 2 (referred to as ‘Rev 2’) draws closer (current best guess is November this year) the need to understand, plan for and become compliant with the new guideline grows stronger. In order to help industry as a whole, and individual companies specifically to tackle this challenge, TRI and Wider Perspectives have…

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