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International Clinical Trials

The Power of Communication

In an increasingly globalised sector, Mark Woolf of Almac Clinical Services evaluates the challenges of clinical trial distribution in emerging markets

The current global nature of clinical trials and the push towards new markets continues to pose fresh challenges. Never has it been more crucial to understand how the clinical supply chain must be managed to access these new markets, be equipped to assess the pitfalls associated with less developed countries and identify what can be done to combat these weaknesses. We look at the relationships between all parties involved in the clinical supply chain and how their roles contribute to successful global IMP distribution.

The challenges presented to every distribution manager for the shipping of clinical trial materials to emerging markets are often identified early with the customer. Patient recruitment is now spreading to countries that have not previously had access to clinical trials. There are also countries that, although clinical trials have been established for three to four years, still present challenges to the IMP professional due to the existence of complex regulatory systems.

Many new trials are being located in countries that often do not have a robust infrastructure or a regulatory system that is tailored for clinical trials. Together these factors produce many of the common pitfalls often associated with emerging markets. China, India and regions such as Eastern Europe, South America and South East Asia all present their own unique challenges to distribution.

Factors leading to globalisation include countries that have now developed economically and have significant populations that can offer excellent patient recruitment opportunities. There is also a greater awareness of clinical trials. Eastern European countries, inaccessible for over 50 years, now offer significant patient recruitment potential and more opportunities to expand the reach of the clinical supply networks, despite regulatory challenges.

DIFFICULTIES FOR IMP LOGISTICS

With new countries and economies come the difficulties of distribution. Studies that are distributed to multiple countries will be subject to different conditions, both environmental and regulatory. Depending on the geographical location of a country, challenges include:


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Mark Woolf worked for 22 years in distribution and supply chain management within the British Armed Forces after leaving full-time education. In 2007 he joined Almac Clinical Services as the Distribution Depot Manager and is responsible for the management of the 20 Almac third-party contracted depots. Mark is responsible for expanding the depot network and managing relationships between the depots and Almac.
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