Foundations of Clinical Outcome Assessment Localization
Accurate and culturally appropriate translation of clinical outcome assessments (COAs), including patient-reported outcome measures, is essential to ensuring reliable data in multinational trials. Foundations of Clinical Outcome Assessment Localization will provide a practical overview of why linguistic validation goes beyond standard translation and how it safeguards both data integrity and patient understanding. The session will cover current regulatory guidance, the steps of the linguistic validation process, and key considerations when selecting a localization partner. The panel will also explore additional considerations for eCOA, quality assurance for multilingual data collection, and case studies illustrating successful COA localization in therapeutic areas such as oncology and rare diseases.
