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Resources

TransCelerate RBM Volume I 27JAN2014

TransCelerate’s Risk-Based Monitoring (RBM) project had a very productive year in 2013. Subsequent to publishing the Position Paper on Risk-Based Monitoring Methodology in May 2013, we have actively worked to network the concepts and embarked on piloting and/or assessing experience among companies that implemented the methodology. The purpose of this RBM Update document is to share the following information…

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TransCelerate RBM Position Paper 30May2013

Current On-site Monitoring practices are frequency-based, conform to a prescribed monitoring visit schedule, and provide generalized quality control at investigational sites. Although this practice does provide a level of control, advances in risk-based approaches and technology provide an opportunity for a more holistic and proactive approach through Off-site and Central Monitoring and a targeted approach to On-site Monitoring. By…

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FDA Guidance on RBM (2013)

This guidance assists sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and biological products, medical devices, and combinations thereof. The overarching goal of this guidance is to enhance human subject protection and the quality of clinical trial data by focusing sponsor oversight on the most important aspects…

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EMA Reflection Paper on RBM (2013)

Good clinical practice (GCP)1 is a set of internationally recognised ethical and scientific standards for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. ICH GCP requires in Section 5.1, that the sponsor implements and maintains systems for quality assurance and quality control; similarly the Article 2 of the GCP Directive 2005/28/EC requires the implementation…

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Large Pharma RBM Implementation

Our client had strong ambitions to implement both risk-based monitoring (RBM) systems and processes across the entire global organization by the end of 2015. They had chosen a system to adapt to their needs and planned to work to the TransCelerate key risk indicators (KRIs). They needed support in developing the technology to meet their needs, needed guidance on…

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ICD E6 (R2) EMA Adopted Guidelines (Jan 2017)

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that…

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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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