According to the U.S. National Institutes of Health, nearly 240,000 clinical trials were registered as of February 2017, comprising all 50 U.S. states and 195 countries. More strikingly, over half of these studies included global (i.e., non-U.S.) sites. Global clinical trial sites tend to be more than geographically disparate: sites are also culturally distinct, differently regulated and at the mercy of unique transportation networks and infrastructures. While the benefits of worldwide studies have been appreciated for decades, the implications are still not fully understood among many study sponsors.
Typically, within sponsor organizations, the best perceived solution to globalization has been to scale commodity sourcing and procurement processes. However, the commodity procurement approach fails to accommodate the full scope of management challenges presented by multi-site, multi-country protocol designs.
These challenges pertain not only to procurement, but also to efficiency, compliance, distribution, privacy, ethics, and budget. The value and benefits of a systemic alternative, called Clinical and Ancillary Supply Chain Management, is explored herein.