An Exploration of the Global Clinical Trial Ancillary Supply Chain and the Drivers of Success During the Pre, In, and Post Phases

Abstract

Until recently, academic and practitioner research on clinical trial supply chains focused on identifying innovative models and solutions in providing comparator and study drugs to global clinical sites. Due to the expansion of outsourcing efforts by pharmaceutical organizations, newly enacted global laws and regulations, and the continued push to increase the speed at which new drugs gain market approval, a new and extremely complex global “ancillary” supply chain has emerged. This manuscript focuses on the clinical trial ancillary supply chain: a supply chain that develops the end-to-end process resulting in the distribution and quality management of medical products and devices, consumable supplies, and patient giveaways to global clinical trial sites. Based on a series of quantitative analyses, this research assesses the influence of the customer, country, and product on the overall success of the supply chain. Three factors emerged from these analyses as having a direct influence on the clinical trial ancillary supply chain; product characteristics, magnitude (components of size), and stability (components of changes in scope). Part II of this research sought to understand the success of the supply chain by evaluating the moderating effects of knowledge management, organizational culture, therapeutic area, and type of shipment. Assessments of 444 customer and server surveys yielded components of a sense of shared culture, shared communication and transparency, and feeling educated and supported. Quantitative data analysis supported that these components had a moderating influence on success during the pre-trial phase of the supply chain. These research findings provide insight into the internal and external drivers of success within the complex and emergent clinical trial supply chain – a supply chain that helps pharmaceutical organizations bring innovative therapies to market and most important, those patients in need of such therapies to improve or even save their lives.