Translation is required at many stages in the course of bringing a drug to market, including clinical research, regulatory submissions, manufacturing, marketing, and packaging. Translation has many roles in the drug-to-market process and can impact the length of the time to market, regulatory approvals, and the marketing. The obligation to translate clinical trial related documents varies from country to country. In the United States, for example, all documentation for all participants and investigators must be in the local language.
Whether translating Patient Reported Outcomes (PROs) for FDA submission or clinical trial protocols, pharmaceutical companies cannot afford to compromise language accuracy or quality.
Our medical linguists ensure:
- instruments are culturally relevant and acceptable to the target population within each country
- language versions are conceptually equivalent to the original instrument and to one another
- instruments are psychometrically comparable
Our rigorous methodologies include:
- forward and back translations
- cognitive debriefing/focus groups for linguistic and cultural validation
- local language adaptations
The leading global pharmaceutical companies, medical device manufacturers, and biomedical firms turn to Global Language Solutions. We have a track record of successfully supporting multinational clinical trials in every major therapeutic area. View our client list.
Contact us for a complimentary consultation and see how GLS can meet your pharmaceutical translation needs.
Pharmaceutical Translation Case Study
A large global pharmaceutical company that does research and clinical development of healthcare products. The company has numerous compounds in development to treat disorders in the neuroscience, oncology, and cardio-renal therapeutic areas, and global strategies that ultimately will lead to the registration and marketing of these products.