Case Study: Controlled Drug Handling

A midsize pharmaceutical company came to Aptuit to work through the complexities of exporting a controlled substance manufactured in the United States and an EU-sourced comparator for inclusion in a clinical trial across more than 12 EU participating countries. The client required a Phase III, Randomized, Double- Blind, Parallel Group, Placebo and Active Controlled, Dose Optimization Study. Inherent in the project was the impact of the conditions and safeguards of the updated DEA export legislation. At the time, the necessary documentation was unfamiliar to the industry. It was the mastery and comprehensive expertise in every facet of Clinical Packaging and Logistics, the availability of appropriately licensed facilities in the United States and the EU and overall clinical packaging and logistics capabilities that made Aptuit the logical choice for this complicated project.

Aptuit's client was dealing with an Investigative Medicinal Product (IMP) manufactured in the United States and an EU-sourced comparator. The dual originations created complications and placed severe constraints on the operational requirements for the study. There was a wide range of issues to be resolved including the handling of titrated dosing forms of the IMP and comparator and one placebo; familiarity and experience with IVRS software; and, managing and integrating the activities at facilities in the US and EU. All of these considerations were compounded by the new DEA legislation conditions and safeguards.