With an emerging Clinical Trial Ancillary Supply Chain™, and little research into effective management models, it has never been more urgent for management systems to step up to an increasingly complex trial landscape. Today’s pharmaceutical landscape relies increasingly on outsourcing efforts. Meanwhile, global rules, laws, and regulations continue to evolve at a rapid pace, and pressure to expedite market approvals for new drugs mounts. Due to the intertwined factors, a new, extremely complex global ‘ancillary’ supply chain has emerged. In this era of change, how does the ancillary supply chain respond to the needs of a rapidly changing industry and create better outcomes for drug discovery organisations and their patients?
As published in International Clinical Trials Journal
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.