Supporting A Regulatory Submission Proactively

Managing large global trials involving tens of thousands of patients is only possible with the help of automated systems such as Almac’s IXRS. Yet, even with the use of software to randomise 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 jeopardise data quality if it is not handled and recorded properly. To ensure that no such anomalies affected the integrity of the data submitted to regulators on two particularly large trials, Almac Clinical Technologies proactively audited and reconciled the records of all manual overrides in the system