Combining field data analysis and simulation to evaluate an alternative Just-In-Time clinical trial supply strategy

Abstract

This paper combines recurrence analysis of field data from clinical trial supply chain (CTSC) with a proof-of-concept inventory profile simulation to evaluate an alternative packing capability that supports just-in-time (JIT) manufacturing and distribution of investigational medicinal products (IMP). Assumptions for JIT packing supply capabilities and expedite quality release were taken from a detailed design prototype recently commissioned by a leading pharmaceutical consortium. The suggested technological intervention is assessed in its ability to reduce finished good inventory while adequately responding to the dynamics of uncertain patient recruitment and required service levels. The proposed combination of field data analysis and simulation enables practitioners to consider the possibilities for a more economically viable adaptive clinical trial supply based on JIT technologies and near real-time product utilisation information across multiple locations.