During the past 10 years clinical trials have become increasingly complex and expensive. Contributing factors include the globalization of trials, and the increasing demand for cold chain logistics due to shifts towards large molecule biologics.
These emerging therapies are high-risk and high-cost. Often the movement of goods is subject to limitations of available infrastructure—both in terms of transportation schedules, as well as available packaging solutions that can ensure product integrity throughout the shipment. In addition, with each country establishing its own regulations, ensuring compliance across the geographic reach of a trial can be a daunting task. Documentation is extensive and complex. Customs clearance can be challenging, especially in emerging markets that are less familiar with the newer therapies.