Right Place, Right Time

Authors: Angus MacLeod, Senior Manager, Global Logistics, Catalent Pharma Solutions, John White, Editor, International Clinical Trials

When considering the best way to import clinical trial materials to South America, making allowances for regional variations in the regulatory approval
process, plus having local knowledge and expertise on hand, is critical as South American countries are increasingly targeted for product launches, pharmaceutical and biopharmaceutical companies have come to recognize that the effective management of clinical trials within these countries is vital to controlling cost and maximizing efficiency, leading to a successful trial outcome. The variable regulatory requirements among countries and the complexity of each regulatory system can lead to considerable variability in the timelines associated with importation of materials, and thus can have a considerable impact on the effective delivery of clinical trial material and ultimately the trial’s success. An appreciation of these variables is clearly important if a trial is to help deliver a product to market quickly and efficiently.

This article will focus on key countries that are regularly targeted for clinical trials in the region and will consider the challenges of effective trial management in Argentina,
Brazil, Chile, Colombia, Mexico and Peru.