Shaping The Future Of eCOA User Acceptance Testing

By Gauri Nagrani and Tim Davis

User Acceptance Testing (UAT) plays a pivotal role in ensuring the success and reliability of electronic Clinical Outcome Assessment (eCOA) data, yet it is often overlooked until the final stages of delivery. UAT is essential for verifying that the eCOA solution has been designed to meet protocol requirements. While large pharmaceutical companies typically have established UAT processes, smaller organizations often lack the necessary knowledge, experience, and resources, leading to UAT being an afterthought and causing issues when the study goes live.

To enhance testing quality and efficiency, sponsors should consider UAT at the beginning of the build process. Early review and feedback can significantly reduce the likelihood of major issues later. Challenges such as simulating 'time travel' and logistical issues with delivery can be mitigated using emulators or online methods. Proactive planning and early UAT involvement in the eCOA design process can substantially improve quality, efficiency, and consistency. This comprehensive approach should be applied across all operational delivery aspects, not just software development.

Gauri Nagrani, co-founder of Safira Clinical Research, underscores the importance of robust operational processes in successful eCOA delivery, drawing on her extensive experience in technology, innovation, data management, and clinical operations.