| Product validation is weighing heavily on CROs – all the more reason to maximise the scope of services offered within the cool chain logistics of clinical trials, explains Mathieu Bordier of Cryo Express
When looking at cool chain logistics, one must start by defining the boundaries of the service and how it fits into the clinical trials process as a whole. With the ever-increasing complexity of product validation and the need for expanded portfolios, there has been an increase in the number of clinical trials and the volume of sample analysed.
WHERE AND HOW TO PROCESS TRIALS?
With healthcare agencies demanding an increased level of information, with products portfolio having to grow to face this heightened regulatory environment and patent limits, and with a limited number of potential patients for any one clinical trial, steps are being made to enter new territories and extend the zone of coverage. With many of the major pharmaceutical industry players situated in the US, this region of the world had a head start in processing clinical trials. When the North American market was about to become fully mature, the logical move to duplicate clinical trials in Europe was made, as that area had similar healthcare systems and levels of development. The size of each domestic market made it possible to service the whole region with a single central lab that can concentrate all the analysis of the samples via a single point of entry. Over recent years, this regional market has become more developed and mature, and is expanding into the Eastern European countries. Relative closeness to the existing European hub/central labs, the abundance of treatment-naïve patients and less competitive patient recruitment are some of the benefits of these new areas. |
