.svg){kind=logo}
Better Patient Outcomes with Epic Language Access Integration
Learn how to improve health outcomes and ensure compliance for individuals with Limited English Proficiency (LEP) with direct language access integration to the Epic Electronic Health Record (EHR) system.
Case Study: Multilingual Retail Marketing
New AI Content Creation Solutions for a Sports and Apparel Giant
Human Expertise Blended With Powerful AI
Lionbridge Aurora AI™ is an AI-first global content platform that increases your multilingual content creation and expands your audience with culturally relevant, hyper-personalized content.
- RESOURCES
Clinical Trial Submissions and Authorizations Data
New Procurement Paradigm for Accelerated Trials
Get in Touch
The European Commission (EC), the European Medicines Agency (EMA), and the Heads of Medicines Agencies (HMA) recently published their 2026 Q1 monitoring report on the European clinical trials environment. The report is part of the Accelerating Clinical Trials in the EU initiative (ACT EU). This initiative aims to increase the attractiveness of the EU/EEA for clinical trial execution by adding 500 additional multinational clinical trials authorized over five years (from 2026 to 2030). The goal translates to 100 additional trials authorized per year, based on an historical average. The performance data of the monitoring reports are retrieved through the Clinical Trials Information System (CTIS), established under the EU Clinical Trials Regulation (EU CTR).
In this blog, our clinical trial translation services team analyzes what the monitoring data reveal about multinational clinical trials in the current EU landscape. Our clinical trial services experts will also review how the data impacts current procurement operating models for clinical trial material translations in an accelerating, expanding clinical trials environment spanning 24 official languages.
Clinical Trial Submissions and Authorizations in Q1 2026
The European monitoring report reveals that 668 Clinical Trial Applications (CTAs) were submitted in Q1 2026. 625 of these were new initial CTAs, and 43 were resubmissions of initial CTAs that were either withdrawn, lapsed, or non-authorized.
To understand the performance data in the context of language services, consider the distribution of mononational vs. multinational CTAs. A multinational clinical trial is conducted in two or more EU Member States and authorized via the single coordinated assessment procedure under the CTR.
According to the Q1 monitoring report, an average of 6 Member States were involved in the 5,106 multinational trials registered in the CTIS as of 31 March 2026 with a regulatory decision (authorized or non-authorized). In Q1 2026, a total of 244 initial CTAs were multinational, and 381 were mononational. Commercial trial sponsors accounted for over 90% of the multinational CTAs (224 out of the 244). The number of multinational CTA submissions that also obtained an authorization from January to March 2026 included:
- 58 authorized in January
- 84 authorized in February
- 110 authorized in March
This was slightly below the total ACT EU target of 86 trials authorized per month.
A New Clinical Trial Material Translations Procurement Paradigm for Accelerated Multinational Trials
The 2026 Q1 monitoring report under the new CTA and CTIS framework reveals that the number of multinational trials remains solid for commercial sponsors. Despite some transitional challenges from the repealed Clinical Trials Directive (CTD) to the Clinical Trials Regulation (CTR), the new harmonized framework for CTAs has encouraged many of these commercial enterprises to centralize their language services. Global clinical trial material translations procurement teams are motivated by internal demands to drive cost savings and AI ROIs. Resultantly, they’re now seeking transparent procurement strategies to keep clinical translation costs down while meeting regulatory compliance and internal demands to accelerate and expand clinical trial conduct (without sacrificing quality).
Through global cost consolidation and due diligence, many sponsors are realizing that translations may be hidden as indirect markup cost items in full-service CRO master agreements. A large pharma enterprise may spend millions of US dollars on R&D content localization. However, clinical trial material translations costs either drown in core CRO service agreements or are separated through indirect procurement cost centers.
Global language service providers (LSPs) are now frontrunners in large language model implementation and content management system integrations. Knowing this, many pharma enterprises are exploring a direct partnership with life sciences translation services providers for better language outcomes in a multilingual, centralized CTA landscape.
Harmonization has long been part of the DNA for the global language services industry. Localizing content without harmonized standards and centralization seldom benefits any global enterprise or any trial sponsors with a global clinical pipeline. Language solutions integrators (like Lionbridge) can provide strategic consultancy on clinical trial material translations strategy and AI-powered translations, content management system connectors, and sophisticated orchestration platforms.
Get in touch
Ready to explore clinical trial material translations solutions with Lionbridge? Need help achieving better patient outcomes and reducing language services costs? Looking to use AI responsibly in your language strategy? We’ve helped hundreds of global pharma and medical device giants. Let’s get in touch.
