Central Labs Go Global

North America and western Europe were traditionally the key regions for conducting international, multicentre clinical trials, and were therefore the natural location for central laboratories when these were first established approximately 20 years ago. The significant expansion of clinical trial activity in eastern Europe and South America over the last 10 years did not have a major impact on the location of central laboratories, since those in North America and western Europe were either in close enough proximity or had good transport links to service these centres. However, over the last five years or so, the focus for clinical trial activity has shifted, with regions such as Asia, and specifically India and China, becoming increasingly important. This has driven the need for the globalisation of central laboratories, and a number of companies have established operations in these emerging markets. Essentially, although a central laboratory can be established in almost any country, there are a number of factors to consider when evaluating potential locations. This article reviews some of the challenges involved in this globalisation, focusing especially on India.

ACHIEVING CRITICAL MASS

The number of CROs with local divisions in emerging markets such as India and the East Asia has grown steadily over the last five years. These companies initially relied on established central laboratories in North America and western Europe, but used local laboratories close to clinical trial sites where necessary – for example, for the analysis of fragile samples where timing was critical and transit times or conditions could affect sample stability. However, the use of local laboratories could be associated with a requirement for additional resources to maintain data quality and regulatory compliance. As a result of the continued growth of clinical trial activity in an emerging market, there is increasing client demand for a locally situated service provider, and once this demand becomes sufficient, it then becomes cost-effective to establish a central laboratory. Unlike CROs, which can easily expand into emerging regions because initial set-up and running expenses are relatively low, the establishment of a central laboratory demands greater expenditure due to the greater complexity and costs of the analytical methods they have to perform. There is thus a ‘critical mass’ of clinical trial activity that has to be reached before it is economically viable for a central laboratory to be situated in an emerging market.