By Korinne D’Orsi, Associate Director of Clinical Supplies, YPrime
A lack of oversight in managing clinical supplies can threaten study outcomes, bring studies to a halt, and even jeopardize a clinical research program. Meanwhile, clinical supply and clinical operations teams frequently handle several studies simultaneously, all of which have many moving parts requiring high attention to detail. Without a solid supply plan in place, this can be a recipe for disaster. This article outlines key components of a solid clinical supply management program, defines interactive response technology (IRT) and its role in clinical supply management, and explains how implementing an IRT system can reduce clinical supply risks and costs.
The Nuts And Bolts Of Clinical Supply Management
Before technology can help a sponsor manage its clinical supplies, a foundation of good practices and procedures must be put in place and executed regularly. When not managed correctly, clinical supplies can be the source of increased risk to the trial as well as escalating costs to the sponsor company. For a sponsor to accomplish successful clinical trials, it will need a solid program for managing its materials, supplies, and doses. This involves understanding the protocol, inventory, destinations, regulations of those destinations, methods of shipping, and number of enrolled patients and then adequately planning for it.