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Avoiding Obstacles

Clinical trial supplies management can be a notoriously difficult logistical task. The opportunity for deviation is further enhanced by having to manage the movement of cold chain material (typically classified as 2°-8°C). This article will look at the most common obstacles encountered when procuring and moving cold chain products, with a focus on comparator products.

More and more clinical trials are utilising comparator drugs and, especially in oncology, most of the existing products are cold chain. There is much to consider when moving cold chain products: gone are the days of throwing in a few gel packs and hoping for the best. The standard expected now is much higher, and correctly so. Regulatory and logistical requirements often shape the delivery protocol. Medicines requiring controlled temperature storage conditions must be distributed in a manner that always ensures that their quality will not be adversely affected. The World Health Organization’s policy on Good Distribution Practice (GDP) broadly mirrors the attitudes published by bodies such as the Food and Drug Administration (FDA), European Medicines Evaluation Agency (EMEA) and the Medicines and Healthcare products Regulatory Agency in the UK (MHRA). In essence, the regulations are harmonious.


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Since joining Pharmarama in early 2008 as Head of Clinical Trial Supplies, Adele Davis has been responsible for managing the operations of the company’s growing Clinical Trial Procurement Teams. She previously worked for over five years in a similar capacity and is a member of the Institute of Clinical Research. She advocates building strong relationships with customers and suppliers alike.

Educated with an Honours degree in Pharmacy from Kings College London, Amandip Sidhu is a practising pharmacist and is a member of the Royal Pharmaceutical Society and the Institute of Clinical Research. Having been instrumental in the rapid expansion of  Pharmarama’s operations since joining in March 2006, Amandip now heads up the Quality Assurance Department, which is at the core of the company’s infrastructure. Amandip is the named ‘Responsible Person’ for the organisation and also oversees all quality aspects of the company’s global operations.

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Adele Davis
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Amandip Sidhu
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