A Conceptual Framework for Logistics Management and Project Planning in the Clinical Trials Industry

Abstract

Background: Logistics management in the clinical trials industry is a very challenging undertaking because it involves multiple stakeholders, complex processes, diverse software applications, intensive white-collar jobs, and onerous quality standards. Current business practices are inefficient and difficult to automate technologies. Methods: This paper reviews the theories and concepts of clinical trials logistics management. The inefficiencies in current logistics management industry are then addressed by building a conceptual framework based on contemporary software tools and architectures, such as web portals, software agents, business process management system, project cards, and resource cards, all interacting with specialized software applications such as accounting, inventory, and label design software. The framework supports data analysis at multiple levels of decision making. To this end, a project planning tool for facilitating and optimizing the operational planning in this industry is designed and presented. Results: The planning tool also contributes to the literature by contrasting several different resource scenarios such as the shared pool, dedicated resources for each project, and the creation of several work groups with dedicated resources. These are Pareto trade-offs. Conclusions: A framework employing a business process management is proposed for clinical trials logistics management. Different managerial scenarios with shared, dedicated, and work group resources are investigated using a case study.