Planning for Return and Destruction
By PCI Pharma Services
Annex I, states that a clinical protocol shall include “a description of the arrangements for tracing, storing, destroying and returning the investigational medicinal product and unauthorized auxiliary medicinal product . . .” Unfortunately, this aspect of clinical supply management is typically overlooked during the trial planning phase, with then significant effort required to compile historical data. In this article, Ed Groleau, Clinical Supply Chain Director at PCI, outlines his top 3 considerations for creating a complete reverse logistics plan for your clinical trial.