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International Clinical Trials

Changing Face

The investigational study of pharmaceutical and biotechnology products is rapidly becoming a global endeavour. While the development of drugs has necessitated material supply such as active pharmaceutical ingredients, and with drug manufacture gradually moving from traditional developed countries like the US or European member states to emerging ones such as China and India, we are now witness to a geographic shift for the implementation of these trials.

International Range


In past years, a multi-country study might have involved only the US and developed European countries. This would require multi-language labelling and contending with the multitude of country-specific regulatory requirements, but would be limited to a handful of countries with advanced healthcare infrastructures to support the needs of a trial.

In today’s market, investigational studies are spreading to many emerging markets – including Russia, Ukraine, Eastern Bloc countries, Latin American countries such as Brazil and Argentina, as well as Central America. There is also a rise in conducting trials in the Asia-Pacific region, with significant population growth and rapidly developing healthcare infrastructure in dense urban areas.

It is, therefore, appealing to carry out investigational drug studies in the Asia-Pacific region, but this does come with risks and challenges depending on the location of the trial sites and the laws governing the country where the study is to be administered. For example, the regulatory requirements in Japan can vary significantly to those in regional neighbours like China, Malaysia, the Philippines, Taiwan, Singapore, South Korea and others. Every country needs to be evaluated independently for its attractiveness and its relative regulatory and logistical risk, as each is distinctly unique.

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Rich Nelson is the Distribution Services Manager for PCI’s Clinical Services group, working with clients to provide seamless global distribution of their investigational products. Rich joined PCI in 2012 after seven years with Fisher Clinical Services, having supported both global distribution of investigational products as well as interactive voice response system solutions. He is certified in Lean Six Sigma/continuous improvement, and is a graduate of Monmouth University in West Long Branch, New Jersey.
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