• July 16, 2024

EMA’s new clinical trials guideline

This guideline, which ensures regulatory compliance with the requirements of ICH GCP E6, came into effect on 9 September 2023. It introduced a new consolidated framework of standards for computerised systems and electronic data in clinical trials. It is a unique guideline in its thoroughness and extent on the matter. OSP had a conversation with Vesta Marciulioniene, director of regulatory affairs at ICON.

What is ICON’s current experience on the implementation of EMA Computerised systems and Electronic Data Guidance?

With our experience to date we serve our customers both in delivery of standard services, as well as continuous consulting with them on our implementation of the guideline and sharing the lessons learned in specific areas of interest to our customers.

In advance of the guidance being published and given its holistic and forward-thinking approach of the guidance, a cross-functional team at ICON, including representatives from over 30 different groups, assessed the impacts of the EMA guidance which was termed the impact-risk assessment phase. Following this initial phase, the team then moved into the remediation and implementation phase, based on the impacts identified during the initial phase – this was called the impact mitigation phase. Just couple of months into the initiative, approximately 75% of the potential assessed impacts were identified as having no risk or low risk and therefore no mitigation was required. This gave us the high level of confidence we were already in a good compliance position as a company from the very start. To date, we have been methodically working with a focus to close all remaining impacts, mainly related to systems, processes and delivery, and we continue to be on the right track targeting to conclude each outstanding mitigation within a defined timeline.

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