Welocalize, a global leader in AI-enabled language and content services, has released a new white paper titled "Beyond Translation: Linguistic Validation for Clinical Outcome Assessments.” As the clinical research landscape becomes increasingly global, maintaining consistency in data collection is paramount, and linguistic validation is key to ensuring patient-reported outcomes (PROs), clinician-reported outcomes (ClinROs), and other measures retain their meaning across diverse settings.

“Linguistic validation goes beyond standard translation, bridging the gap between linguistic accuracy and cultural relevance,” comments Muntsa Cuchí, Life Sciences Sales Leader, Europe, at Welocalize. “This white paper details the rigorous workflow needed to support high-quality data and patient-centricity, underscoring the importance of cultural nuances in clinical research.”

The white paper provides a step-by-step guide on linguistic validation, covering topics such as the linguistic validation workflow, regulatory considerations, universal vs. country-specific translations, and practical challenges in implementation. With guidance from this document, clinical research organizations and pharmaceutical companies can make informed decisions on linguistic approaches, ensuring data accuracy and integrity across multinational clinical trials.

Key Highlights:

• The Linguistic Validation Workflow: A structured, multi-step process including forward and back translation, clinician review, and cognitive debriefing.
• Regulatory Landscape and Practical Implications: Guidance on aligning linguistic validation practices with FDA, EMA, and ISO standards.
• Universal vs. Country-Specific Translations: Insight on balancing budget with cultural specificity to achieve optimal data quality.

Download the white paper to learn how linguistic validation can enhance the quality and consistency of clinical trial data.