Top 10 Life Sciences Regulatory Translation Blogs in 2024

#10 AI and Drug Development with Modern Clinical Trial Designs

Clinical development plans with modern clinical trial designs require obtaining language efficiencies under untraditional protocol designs. This blog considers how to manage high volumes of submission content and mid-trial repeat regulatory translations via AI-powered solutions.

#9 Global Translation Glossary: A Life Sciences Guide

Discover the many benefits of glossaries for regulatory translations. Download our recent white paper on global translation glossaries for life sciences regulatory compliance. A solid glossary can enhance consistency, efficiency, and cost savings. As part of global regulatory solutions, glossaries can also augment the efficacy of certain AI solutions, such as automated or assisted post-editing. Read the white paper to learn what characterizes an effective glossary and get our five best practices for developing a regulatory translation glossary.

#8 Lionbridge’s ISPOR Posters

Lionbridge attended ISPOR EU. We shared two poster contributions:

• “AI-powered Precision for Comparative Review in Clinical Outcome Assessments”

• “Transforming Concept Elaboration in COA Localization: A GENAI-BASED APPROACH”

#7 Ensuring Life Sciences Regulatory Compliance

The EU’s 24 different official languages and regulatory systems complicate its language requirements for medical products. This blog explains how medical products are regulated on three different levels regarding language, which isn’t harmonized in the same way as technical requirements.

#6 AI Language Strategies and Medical Device Translation Services

This blog argues that manufacturers miss out on significant cost-savings and language consistency due to a siloed approach to requesting language services and regulatory translations across the MedTech enterprise. In a device’s life, content accumulates and repeats. Technical documentation is highly interdependent. We encourage customers to think strategically about language outcomes to manage increasing volumes of regulated content and scale up language outcomes. This will alleviate pain points, such as a lack of visibility across the language category, missed cost-savings, lack of language consistency, and efficiencies.

#5 COAS: Migration with Lionbridge Aurora Clinical Outcomes

Aurora Clinical Outcomes is an innovative, proprietary technology Lionbridge offers. It enables accurate and efficient migration of COAs from paper to electronic format. In this video, we presented the benefits of this solution, including an automated, controlled process and consistent accuracy between electronic and paper COAs. eCOAs allow for modern decentralized data capture of patient outcome data.

#4 AI Solutions for Multinational Clinical Trials

The transition from the EU Clinical Trials Directive (CTD) to the Clinical Trial Regulation (CTR) ends in January 2025. Clinical trial applications must be submitted through the new Clinical Trials Information System (CTIS). A single application can be submitted for trials run in more EU countries. A centralized assessment across EU member states will reduce the burden and time for approval of clinical studies in the EU. The harmonized procedure is expected to boost multinational trials in the EU. This blog explores how a centralized AI-powered language strategy can drive language efficiencies from trial level to drug filing.

#3 AI in Life Sciences and the Drug Pre-Market Stage

In a blog series, we explored how a life cycle language strategy can be implemented with efficiency and quality gains through the drug’s life cycle stages. We encouraged our drug sponsors to think strategically about language outcomes via regulatory translation and leverage AI to obtain cost-savings, efficiencies, and language consistency throughout the product’s life. Setting up a life cycle AI language strategy from the pre-market stage enables transfer of language assets from early clinical development to regulatory filing and later launch and post-market reporting stages. It also helps control consistent product claims and messaging.

#2 4 Challenges of SSP and SSCP Language Requirements

In 2024, Lionbridge received increasing requests from medical device manufacturers to translate summaries of safety and performance (SSCPs and SSPs). The EU Medical Device and In Vitro Diagnostic medical device Regulations legally require these SSPs and SSCPs. These summaries must be validated during conformity assessment and translated for public disclosure on EUDAMED. Some summaries contain a part intended for patients or laypersons, precipitating a new demand for readability testing.

#1 Generative AI Language Services eBook

To demystify Generative AI and Large Language Models, we published an eBook on how they can be applied to regulated content under a risk-based language strategy. With AI-first becoming a guiding principle for language solutions, knowing when and how to ensure human-in-the-loop for quality assurance and risk control is critical. Our multi-disciplinary team of AI, language, and industry subject matter experts help customers determine suitable workflows for regulated content.

Get in touch

Need assistance with your language strategy or maintaining or reaching compliance in 2025? Lionbridge’s Life Sciences translation services experts are here to offer reliable, cost-effective pharmaceutical translation solutions and medical device language services. We’ve been partnering with industry giants for decades. We’re also staying updated on the latest AI and life sciences solutions. Let’s get in touch in 2025.