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Pharmaceutical Manufacturing and Packing Sourcer

Keeping It Moving

Recent research published in the Journal of Clinical Trials details that the number of countries serving as clinical study locations outside of the US has more than doubled in the space of 10 years (1).

Many factors contribute to this globalisation of clinical trials cost reduction being a major one. For example, a clinical site in India is estimated to be up to 10 times cheaper than a clinical site based in the US (1). Globalisation can also decrease the duration of a trial due to an abundance of potential for study participants, thus speeding up patient enrolment (1).

Nevertheless, as the world of clinical research becomes smaller, the list of challenges associated with orchestrating a globalised study multiplies. From a logistics perspective, several fundamental factors need to be considered to capitalise on globalisation. Understanding the nuances of a global distribution network to obtaining a firm grasp of the import/ export requirements can make or break a study. It is imperative to comprehend the country-specific importer of record (IoR) processes, product valuation methodology, lead times, documentation requirements, airport facilities, broker interactions, and temperaturecontrolled shipping solutions, to name a few. To safeguard investment, protect the patient, and ensure the safety and efficacy of products, the fundamentals of global clinical supply distribution cannot be overlooked.

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Sharon Courtney is Logistics Services Manager at Almac Group and has worked for 18 years in the clinical supply chain. She has expert knowledge in a number of key areas within the end-to-end supply chain process, including management and control of temperature-sensitive shipments; risk mitigation (identifying and managing risk); developing and managing robust relationships with transport partners; chain of custody responsibilities; active and passive shipping solutions; and import/export country knowledge. Sharon has first-hand knowledge of working with customers, external organisations, and the appropriate departments within Almac to deliver well-established logistics solutions in the pharma industry. She has travelled widely with her work and has been instrumental in the development of the logistics service provided by Almac.
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