AI for Clinical Trials

Centralized Submission Dossiers Across the EU: A New Opportunity

Implementing the Clinical Trials Information System (CTIS) in the EU allows clinical trial sponsors and medical device manufacturers to submit a single clinical trial application dossier for multinational studies conducted in the EU. The EU Regulations (CTR, MDR, and IVDR) and the CTIS platform facilitate a joint authorization process across all EU Member States.

The clinical trial authorization process is streamlined into a 45-day procedure, with one Member State acting as the Reporting Member State (RMS) and responsible for coordinated assessment across all concerned Member States. This process cuts the procedure by 15 days, compared to the previous 60-day process. It includes these sequential steps:

• 26-day assessment phase
• 12-day coordinated review phase
• 7-day consolidation phase

In parallel, during the same 45-day assessment window, Ethics Committees in each Member State review Part 2 of the application dossier.

Language outcomes during the coordinated review and consolidation phases may require rapid revision, or regulators may request additional information in local languages. The trial team must respond quickly to regulatory Request for Information and swiftly manage language activities across all countries to avoid delays or automatic application lapses.

Centralizing Language Outcomes for Combined Drug-Device Studies

AI-supported language outcomes don’t just have potential at the product level. Clinical trials increasingly combine investigation of a medicinal product with the performance study of an In Vitro Diagnostic device or a clinical investigation of a medical device.

Although a lack of alignment has been identified in the clinical trial authorization process across CTR, MDR, and IVDR, a centralized approach to language outcomes can also drive efficiencies for combination studies. Lionbridge recommends using AI for clinical trials’ language strategy across content types for combination studies. Terminologies, language assets, and content can be shared across an In Vitro Diagnostic device combined with medicine to support personalized medicine development. During development of the drug and its companion diagnostic, AI workflows can be predefined and implemented alongside glossaries, helping:

• Drive efficiencies
• Change procedures
• Aligning messaging and performance claims to support mutual endpoints

Treat Your Language Service Provider Like a CRO

With escalating clinical research costs, Contract Research Organizations (CROs) have become essential to successful and efficient clinical trial execution. Over time, their role has evolved from a service provider assuming administrative trial duties to becoming true partners who influence:

• Trial design
• Data management
• Patient recruitment

Digital trial execution and AI for clinical trials have also opened new avenues for strategic partnerships across the B2B relation.

With Large Language Models (LLMs) transforming the entire content journey, sponsors can now engage in similar strategic partnerships with Language Service Providers (LSPs) and fully benefit from AI for clinical trials.

Get in touch.

Ready to explore language and content solutions to support your full drug and medical device development life cycle? Lionbridge offers unique multidisciplinary expertise with LLMs, language excellence, regulations, and life sciences content. We offer advanced and bespoke AI solutions, from planning to creation, analysis, summation, and localization. Let’s get in touch.