Global clinical trials result in multiple vendors across multiple global sites treating patients from a variety of cultures speaking different languages. Diverse cultures and languages add significant complexity to the clinical trial process. Welocalize Life Sciences provides professional translation and linguistic validation of Clinical Outcomes Assessments (COAs) into over 200 languages for use in global clinical studies. Our life science industry focus has made us experts in translating clinical documents for use in global clinical trials.
While every translation should have high quality standards, some types of translation, such as the those for patient-facing materials in a clinical trial, require more steps. Linguistic validation and cognitive debriefing ensure that all components of COAs are interpreted in the same way across diverse populations and are conceptually equivalent across multiple languages and cultures. These extra steps guarantee translation quality and allow for study data to be pooled and compared.
Our rigorous methodologies include:
- Forward and back translations
- Cognitive debriefing and focus groups to determine equivalence of concept
- Local language adaptations
These methodologies 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
We have more than two decades of clinical trial translation expertise. Some of the documents we translate include:
- Abstracts + Manuscripts
- Clinician-Reported Outcomes (ClinROs)
- Patient-Reported Outcomes (PROs/ePROs)
- Observer-Reported Outcomes (ObsROs)
- Clinical Outcomes Assessments (COAs/eCOAs) Patient Diaries
Without linguistic validation and cognitive debriefing, clinical research trials are in danger of being rejected due to patient misunderstanding of poorly translated clinical instruments. Welocalize Life Sciences has a proven track record of successfully supporting multinational clinical trials in every major therapeutic area from early stage through commercialization.