Healthcare & Life Sciences March 2024
Multi-language clinical trial documentation
Client: Multinational Pharmaceutical Company
Sector
Healthcare & Life Sciences
Date
March 2024
Services
Medical translation, Back-translation
The challenge
A Phase III oncology trial recruiting across multiple regions needed informed consent forms, patient diaries, and adverse event reporting templates translated into Arabic, Spanish and Mandarin with full regulatory back-translation verification.
Our approach
Assigned medically qualified translators (one with an MD background). Implemented full back-translation by an independent second team. Worked through three rounds of regulatory review with the trial sponsor.
The outcome
All documents accepted on first regulatory submission across four countries. Trial enrolled 320 patients on schedule.