How a Data-Driven Quality Management System Can Manage Compliance Risk in Clinical Trials

Abstract

A majority of data presented to global regulatory agencies during the approval stage of an investigational product is collected during its clinical development. Any concern or doubt about the integrity or quality of clinical data, compliance with GCP, or ethical standards during regulatory review can lead to costly delays in the granting of a marketing authorization. This risk can be minimized if accurate metrics are used to continually monitor the quality of the contributing research operations. As highly cost-effective tools, metrics can be used to monitor operations throughout this phase of development. With continuous monitoring, proactive measures can be implemented to prevent issues from escalating into regulatory concerns. This article describes the development of a quality management system based on a data- and metrics-driven compliance strategy. Combined with an electronic information management system, the aim of this system is to monitor and manage cost and timelines while ensuring the quality of clinical research operations.