Validation for Clinical Trial Translation
The Declaration of Helsinki, the Belmont Report, the requirements of the FDA and similar regulatory bodies all establish a firm basis for the provision and execution of accurate and accessible communication for non-English speakers participating in clinical trials.
The most widely recognized clinical trial translation methodology for patient-reported outcome instruments is perhaps the most rigorous quality assurance process used in the translation industry. In fact, it’s so tough and expensive that no one uses it.
In the US, non-English speakers are often excluded from clinical trials due to the headache and expense of managing the required communications with them. And when non-English participants are enrolled, the quality control standards usually fall far short of even the most cursory standards employed by professional translation service providers in other industries. But it does not have to be that way. Quality is achievable around the world.
We encourage you to get in touch to discuss your translation concerns and requirements. We will help you find a way forward that is safe, cost-effective and complies with appropriate regulations. And that includes validation.
Validation is a key tool in clinical trial translation, but what kind can vary considerably. Are you unsure of what the best validation methodology for your clinical trial is? Consultative planning and customized workflows are what we do best. We provide validation solutions that are right for clinical trials of different sizes, budgets and regulatory compliance considerations.
Responsive Translation is ISO 9001 and ISO 13485 certified. We have dedicated life science teams of experienced linguists that specialize in clinical trial translation and quality assurance. Some of the validation services we offer include: back translation, linguistic analysis, cognitive debriefing, clinical review and harmonization.
To discuss your specific requirements for clinical trial translation validation, please contact us at 1-800-872-6752 (+1-212-355-4455 outside the US) or firstname.lastname@example.org.