Clinical Trial Translation Whitepaper

The EU Clinical Trial Regulation (CTR) was a major reform within the clinical research community and the life sciences industry. It deeply impacted the application, approval, execution, and reporting of clinical trials and clinical trial translation in the EU. Clinical Trial Applications were centralized in the EU through the Clinical Trials Information System (CTIS), and joint review procedures were established across the 27 EU Member States. The joint review procedures greatly impacted how trial sponsors, regulators, and the clinical supplier landscape interact. It also impacted standard timelines. Timelines were cut from 60 days under the repealed EU Clinical Trials Directive (CTD) to 45 days in the CTR. In addition, the regulatory windows for Coordinated Review and Consolidation of the clinical trial application Assessment Report were set to 12 days and seven days, respectively. These shorter timelines accelerate trial approvals and put sponsors under pressure. According to the Regulatory Affairs Professionals Society, adapting and innovating the translation process for clinical trial documentation is one of the key challenges of the single regulatory framework for clinical trials in the EU. The trials were fully transitioned on January 30th, 2025; after the extended transitioning process.

This whitepaper by our life sciences translation experts offers EU CTR analysis and recommendations. We cover how the new system impacts content and language outcomes, including clinical research translation. We’ll also share how Lionbridge’s regulatory translation services can help trial sponsors succeed within the stricter timelines and promote transparency for clinical research in the EU.  

The insights from our life sciences translation experts focus on:

• Potential language barriers in the centralized procedures with the EU’s 24 official languages

• How a centralized single vendor translation approach can unburden trial sponsors in the single regulatory framework

• How to achieve high-quality plain language summaries and improve patient understanding of clinical research.

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Need more guidance for your clinical trial research translations? Or wondering how generative AI and life sciences can help you reach tighter deadlines or generate more multilingual content? Let’s get in touch.