Translation of eCOA in Global Studies – Challenges & Solutions
Click here to register for free and to view the entire webinar: http://xtalks.com/Language-Components... Speakers: Colleen Chulis, Global Director of Linguistic Validation, TransPerfect Brielle Sydor, Account Executive of Linguistic Validation, TransPerfect Jane Carter, Program Director, CRF Health Increasing competition between pharmaceutical companies to get drugs to market faster causes increased challenges: Companies are trying to collect more data within a clinical trial, and are therefore using more eCOA instruments than in the past Global studies require additional translations The additional work and increase competition means shortened timelines These additional components need to be provided to an ever increasing number of Ethics Committees, resulting in shortened timelines This presentation discusses the translation process, needs, requirements, review cycles, and regulations surrounding the use of eCOA in clinical studies and the need for linguistic validation. Learning objectives: Understand language translation considerations for implementing eCOA solutions in a clinical trial, with respect to process, timelines, and circumstances for linguistic validation Increase awareness of best practices when migrating a paper translation to electronic format, or when translating solely for an electronic device