Linguistic Validation
Our experience in translating COAs has expanded across a variety of therapeutic areas, including cardiovascular, allergy/respiratory, oncology, gastroenterology, inflammation, neurology, infectious diseases and vaccines.
Our global relationships with translators, interviewers, instrument developers, survey research experts, clinicians and in-country reviewers allow us to expedite each linguistic validation project with ease and scientific accuracy.
OUR METHODOLOGIES
Our state-of-the-art linguistic validation process and COA value-add services ensure both accuracy and timely completion of documents.
Our linguistic validation process is modeled on the U.S. Food and Drug Administration PRO guidance document as well as on the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Good Practice recommendations.
The linguistic validation process includes the following key steps:
- Concept elaboration
- Dual forward translation
- Harmonization
- Back-translation
- Survey Research Expert review
- Developer review
- Clinician review
- Client subsidiary review
- Recruitment of patients
- Cognitive debriefing of patients
- Validation reports and certifications
COA VALUE-ADD SERVICES
We manage the entire life cycle of your COA translations. Our approach provides an array of support services designed to save you time and increase your ROI:
- Copyrights and licensing management
- Developer coordination
- Detailed and accurate instrument research
- COA repository management
- Manuscript and poster creation
ELECTRONIC CLINICAL OUTCOMES ASSESSMENTS
With more and more sponsors utilizing electronic devices to conduct their clinical trials, it is extremely important that the eCOAs are developed and linguistically validated with the same level of precision as a traditional paper COAs. Partnering with RWS Life Sciences ensures a thorough review and proper linguistic validation of the adapted instrument for use on an eCOA or ePRO device when required.
Our experience and expertise in this area have led us to develop a series of best practices for eCOAs including:
- Upfront communication between sponsor, eCOA vendor and translation provider
- Close coordination throughout project between all three parties via regular teleconferences
- Bank of validated eCOAs for future use by the client
- Documentation that eCOAs match validated translations
- Font pre-test
- eCOA device training where applicable
