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 whilst we are showing 33% of companies not having started any form of preparation yet, those companies are clearly aware of the changes and the need to start preparation – no one in our survey responded that they didn’t know of the changes. The remaining 67% are in action already, and this certainly fits with our expectation of where companies should be by now.

The reality is that the guidelines are not expected to be finalized until November this year and so it is natural that many companies will wait until those guidelines are set in stone before going too far in terms of adoption. We do know from public statements by members of the ICH working group that minor adjustments rather than any reduction in the draft revision can be anticipated. So taking the guidance as it currently stands from a preparation and planning perspective would seem a wise and low risk approach.

It should also be noted that the revisions are not trivial, and therefore nor is their adoption. With a completely new section (section 5.0) on Quality Management, incorporating Risk-based Monitoring, the adoption of these guidelines by industry is going to require changes in processes, roles and technology. This may give us some insight into the general hesitancy, and also why many companies may be waiting to see what their peers do before making too much of a commitment themselves.

What timelines do we advise companies to adopt?

At this stage we can’t be sure at what point each of the regulatory agencies will adopt the new regulations, though it is safe to assume that the approach taken 20 years ago may be a good indicator. As the diagram below shows, the EU were the first to adopt, followed by Japan, the US and then Canada over the course of the next 12 months.

adoption jpg

Conservatively, we would expect the EU to be adopting the guidance in 1Q17, with Japan, US and Canada adopting by the end of next year. The likelihood is that the global regulators may act more swiftly, having done this once before. Given these timelines, we would certainly expect anyone running trials that include Europe to be well into the planning phase by now in order to give their organisations the time needed to assess the impact, put an implementation plan together and then start building their competencies.


What are we doing to help?

At TRI we are committed to helping our customers and industry in general with the adoption of quality management and risk-based monitoring. We invest a lot of time and effort putting information into the public domain to enable others to learn from the experience we have gained in building capability and maturity for our customers.

To help get companies started, we have put together a simple framework to help define the major areas of consideration and the sequencing of activities. These are shown in the diagram below:


Companies want to be able to turn to one company for a complete solution for ICH GCP E6 Rev 2 readiness. In order to support that need. TRI offer that solution with three core components:

1 – Consultation:

We offer a full range of professional services –  everything your company could need in order to get up and running quickly and efficiently:

  • Assessment and planning
  • Process definition and implementation
  • Protocol risk assessment and indicator design

To find out more, please click on the following link:

Professional Services


2 – Training:

We offer a full range of training services, both on RBM processes and tools and on the incoming ICH GCP E6 Rev2 guidelines. For more information on both of these areas please follow the following links:

RBM training

ICH GCP E6 Rev2 Training and Certification


3 – Technology:


TRI have spent the last 2 years developing and perfecting our quality management and RBM platform, OPRA.

OPRA is a cloud based, per study platform which is user friendly, intuitive to use and fully configurable for the needs of each company and study.

To find out more about OPRA, please follow the link below: