Biopharmaceutical Clinical Labeling Case Study

Clinical labeling is a stringent, rigorous process that protects the health and well-being of trial participants. Procuring reliable, accurate, and efficient life sciences translation services is critical to maintaining compliance and meeting the tight deadlines required by regulatory bodies and the trial’s logistics. A particularly crucial element of clinical labeling is the Master English Label Text (MELT). The MELT must be created based on various essential clinical trial documents. It must also be tailored to different packaging types, including cartons, syringes, bottles, etc. The regional regulatory requirements for these labels vary frequently, requiring additional customization before these labels can be translated into the required target languages.

Lionbridge has been helping a global biopharmaceutical company translate label phrases for its Investigational Medicinal Product (IMP) labels since 2016. Our customer, headquartered in the U.K., has extensive global reach. Its R&D focuses on several therapeutic areas, including infectious diseases and oncology. Lionbridge has assembled a team of life sciences translation and clinical trial translation experts, project managers, and cutting-edge technology to serve this customer. We’ve been helping them create compliant IMPs across many languages, including some that pose unique challenges. These languages include Hebrew, Japanese, Thai, and Korean. Lionbridge also developed a streamlined process for this BioPharma giant’s translation needs, particularly for its high frequency of rush orders. Using our deep domain expertise and technology-enabled processes, Lionbridge was able to deliver on projects, meeting quality standards and delivering 50% faster than initially agreed-upon timeframes. Discover how Lionbridge’s clinical trial translation services have supported our customer’s clinical labeling needs for almost a decade.

Read the case study to learn about Lionbridge’s customized solution for a noted, global biopharmaceutical company.