Catalent

Global, cGMP Micronizing and Milling for the Pharmaceutical Industry

AsiaPacific Region Studies, Common Clinical Supply Challenges

Catalent

The number of clinical trials in the Asia-Pacific (APAC) region is growing as sponsors tap into expanding pharmaceutical market.

In many APAC countries, trials are often the only avenue available to patients to receive treatment. Patient compliance is generally very high. In addition, an overall growing level of sophistication within the region has led to improvements in data collection accuracy and increased intellectual property protection.

Challenges associated with conducting studies in this region can and do vary by country and whether the study sponsor is a local company or not. Unlike well-established clinical trial regions such as Europe, the APAC region is a collection of independent countries each with its own infrastructure limitations, clinical supply quality standards, regulations, and protocols. This means that the logistics involved to get clinical supplies to the right place at the right time within the region can be quite complex and is perhaps one of the most significant challenges that must be overcome.

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