Staying On Track With A FDA Regulatory Submission When Manual Intervention Is Required

Managing large global trials involving tens of thousands of patients is only possible with the help of automated systems. Yet, even with the use of software to randomize patients and manage kit assignments, anomalies can crop up in the way that sites deal with patients and kits. From time to time, studies require manual intervention in the system records—a process that can jeopardize data quality if it is not handled and recorded properly.