Streamlining clinical trial start-up with a kanban system: a case study to improve efficiency and reduce costs

Abstract

This paper proposes the use of a Kanban system to improve the conduct of clinical trials for drugs and medical devices. The main goal is to shorten the lead times in clinical trial start-ups, resulting in faster access to new therapies and cost savings. Additionally, the proposed system aims to increase employee satisfaction through workload balancing and empowerment. The research is qualitative and can be further typified as a combination of case research and action research. To identify the causes of long lead times in clinical trial start-ups, two Contract Research Organizations (CROs) that conduct clinical trials for sponsors were analyzed. The proposed Kanban system was implemented in one of these companies to test its viability and results. According to initial estimates, the results show a possibility of achieving a lead time reduction of at least 7% per study. This translates to savings of about $680,000 per Phase III study of the trial and significant improvements in employee satisfaction.