Addressing The Challenges Of eCOA Licensing

By Willie Muehlhausen and Tim Davis

In the evolving landscape of electronic Clinical Outcome Assessments (eCOA), significant advancements have been made in the process of adopting electronic data capture. Regulatory authorities now recognize BYOD ePRO data as primary endpoints. Despite these advancements, challenges in instrument licensing and linguistic validation persist often delaying first-patient-in (FPI) milestones. The licensing process is particularly burdensome on authors from smaller organizations who lack the resources to adapt these tools swiftly, resulting in prolonged approval timelines. Furthermore, complex procurement processes among sponsors and vendors can contribute to these delays. To enhance the efficiency of licensing and expedite FPI, the industry must embrace scalable solutions that assist authors in creating electronic versions and reusable source files, thereby reducing the need for exhaustive reviews for each study and language variant. In this article, we learn more about how early engagement in the licensing process, coupled with careful selection of Contract Research Organizations (CROs), can facilitate quicker access to necessary source files.