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International Clinical Trials

Devolved Distribution

 

Global clinical studies are complex organisational exercises and one of the most demanding aspects is the management of the Investigational Medicinal Product (IMP) supply chain. It goes without saying that it is imperative to the success of the trial that the drug reaches the investigator site and the patient on time, without compromising the quality of the medicine. Failure to achieve this can lead to delay or failure of the study and, in the worst-case scenario, patient safety can be compromised.

The growth in the biopharmaceutical market in recent years has meant that many more IMPs are temperature-sensitive, requiring cold chain shipment. However, the rapid emergence of new territories for clinical research, where the transport infrastructure may be less well developed, has also led to an increased focus on the transport of products at controlled room temperature – ‘temperate chain’ shipments. The supply chain requirements during a clinical study can be particularly challenging; quantities of packs shipped may vary from shipment to shipment, blinded packs may not be easily replaced if the contents perish, and the product itself may be scarce and very high value.

Many sponsors will outsource the management of clinical supply distribution, either directly to a preferred provider or via their chosen clinical research organisation. Either way, it is important that the outsourcing group understands the requirements of setting up the distribution management system, so that potential issues and expectations can be addressed at the outset. This article will review the thought process in setting up a typical distribution network for a clinical study, the regulatory requirements and some common operational issues.

ESTABLISHING PRODUCT AND SHIPPING REQUIREMENTS

Early in the planning stage, it is important to focus on the product requirements, as these will drive the planning of the shipment system. Some of the questions that need to be addressed are: what are the storage and transport temperatures? If the product is to be stored refrigerated or frozen, can it be transported at room temperature (15-25ºC) and, if so, how long can it remain at the higher temperature? How is the patient kit to be defined?


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John Engelhardt obtained his HND in Industrial Management from Glamorgan University in 1985. Before joining Penn Pharma in 2002, John worked as supply chain manager for Sony Manufacturing in Pencoed and at Stadco Ltd as the Logistics Manager. John is Head of Storage and Distribution at Penn Pharma, charged with the role of merging the silo warehouse operations into one operational group.Keren Winmill obtained her degree in

Pharmacy from the University of Wales in 1975, qualifying as a pharmacist in 1976. Working initially with the Technical Secretariat to the Committee on Safety of Medicines, and after 10 years in various roles at Ciba Geigy in Switzerland and the UK, Keren joined Penn Pharma in 1990. After a period at Quintiles, Scotland, as Business Development Director, she returned to Penn as Director of Clinical Supplies. Since June 2006, Keren has acted as an independent consultant, working with Penn and other leading pharmaceutical companies.

 

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John Engelhardt
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Keren Winmill
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