Case Study: BioMarin achieves cross-cultural equivalence for 14-language PROs with Lionbridge

How can you ensure that a clinical trial is understood by all participants across multiple languages

BioMarin engaged Lionbridge Life Sciences to provide linguistic validation services for its Phase 3 program in adults with severe hemophilia A. Lionbridge was tasked with translating three patient‑reported outcome (PRO) instruments into 14 languages across four continents, ensuring conceptual and cultural equivalence so PRO data could be pooled and compared, while also handling tight IRB/IEC deadlines and the challenge of recruiting rare‑disease respondents for cognitive debriefing.

Lionbridge used an industry‑recognized methodology (dual forward translation, reconciliation, back‑translation, comparative review and in‑country cognitive debriefing), produced finalized translations with linguistic validation reports and certificates, and employed risk‑based planning (e.g., clinician review for Belgian German and telephone debriefing for Austria) to meet timelines without sacrificing quality. The outcome was regulator‑ready, high‑quality translations covering 14 languages, 4 continents and 3 PRO instruments, enabling cross‑cultural data comparison and supporting BioMarin’s regulatory submissions.

BioMarin