Life Sciences

Patient-Reported Outcomes

Technical Language Services has created a specialized business unit dedicated to providing superior Linguistic Validation (LV) services. The expert team at TLS understands the complexity of the human mind, emotions, feelings and quality of life. Our highly trained linguists are professionals and subject-matter experts in numerous therapeutic fields, and have a vast knowledge of LV procedures and rigorous methodology. Our management team has considerable experience in the areas of psychology, public health, psychometrics, cognitive debriefing, and cultural/linguistic diversity, and this ensures a competent coordination of multi-language/multi-instrument projects.

Life Sciences: Reliable Data from Reliable Translations

The need for the pharmaceutical industry to gather accurate, reliable data from global clinical trials has increased exponentially in the past several years. The process of translating or culturally adapting Patient Report Outcomes measures (PROs) is progressively regulated, and vital to yielding statistically meaningful (and reliable) data.

Our Life Sciences Team is cognizant of the importance of accuracy and conceptual equivalence, and our methodology has integrated numerous quality checks throughout the process to ensure just that.

Your Questions – at the Patient’s Reach

Patient research regulatory authorities require that any questionnaires to be completed by the patient be written in the patient’s native language. The level of comprehension must be such that all concepts are understood by the average native subject. It is also vital that the translations convey exactly the same concept as the original questionnaire, and that these concepts are consistent for all languages in a specific protocol.

TLS’ Life Sciences Team ensures that conceptual equivalency is achieved. We make sure that the questionnaire developers are consulted, and can also provide, should the client request it, independent clinical review of every translation.

Why choose TLS?

Our division offers Complete Protocol Packages — this ensures consistency of terminology and adherence to regulatory submissions. We will translate and validate your PROs, but also translate all protocol-related documents and thus give you a full study coverage. You can entrust your Informed Consent forms, patient recruitment materials, physician instructions, marketing notices, etc. We will give you a complete package with inter-documentation and inter-language/country cohesiveness. We will also offer advice on master trial documents and make sure you get certifications for each document with detailed methodology, for your records and audit trail.

Expert consultation services and research: Our Project Coordination team will work with your study management and Outcomes Research team to customize every project to your protocol needs. We can offer advice on questionnaire development and selection, potential translation issues (assessment of original questionnaire), liaison with developers and copyright holders, and securing license agreements.

Quality: Our translations are accurate, culturally-adapted, and conceptually equivalent to the original and all other languages.

Speed: TLS’ experienced Life Sciences Team can produce expedited translations without compromising the final product. Our project managers will work with you on your timelines to ensure validated, approved documentation for your First Patient First Visit (FPFV) to be successful in every study site.