March 5, 2024

What Does Clinical Trial Monitoring Have to Do with Lab Kit Management and Sustainability?

When it comes to clinical trials, lab kit waste is a hot topic. Not only do expired collection supplies wreak havoc on study budgets, but their impact on the environment and on relationships with research sites is undeniable.

In a world that is increasingly mindful of sustainability, sponsors are trying to deliver on commitments to reduce their carbon footprints. But even the best-intentioned organizations can struggle to keep the over-ordering of lab kits and shipping supplies at bay. Complex study designs translate to complex kitting schemes, and managing inventory on a global scale can be a challenging feat. Enrollment rates can be hard to predict, and it can be tempting to provide a surplus of supplies to sites located in countries with import requirements that add several days or weeks to supply transit times. Site personnel can be trained and retrained to better manage their inventory, but paper-based processes, high turnover, and overwhelming work conditions can diminish the effectiveness of these efforts. As a result, countless tubes, syringes, bulk supplies, and other kinds of clinical inventory are rendered useless and discarded.

When we consider that a primary purpose of monitoring is to optimize data integrity, ensuring that sites are equipped with the supplies they need for a clinical trial at all times stands as a critical study deliverable. But why should we prioritize a monitoring strategy that also drives more sustainable inventory management?

Supply waste can have a significant budgetary impact

Clinical operations personnel may find themselves having to answer for hundreds of thousands — sometimes even millions of dollars — in lab kit overage over the life of a study. Unfortunately, many traditional kitting vendors are struggling to come up with an overarching solution to the problem — especially because they may be incentivized based on volume, or may otherwise be incapable of optimizing startup and resupply orders. Many of them are walking a fine line between earnestly addressing their clients’ concerns about budget overages stemming from unsustainable waste, and protecting their bottom line. Attempts at mitigating supply waste by providing inventory reports and visibility to metrics may seem like legitimate attempts to save their customers some money, but these tools are not conducive to proactive supply management. 

Supply waste puts added strain on research sites

Supply waste also has implications for a sponsor’s relationship with their investigator sites. With sponsors coordinating supply orders directly with their kitting vendors and CROs — especially during the startup phase of the trial — sites are oftentimes left to manage an excess number of lab kits and supplies (shippers, dry ice, etc.) that take up valuable space in their facilities. Once sites receive their first order of supplies, they are expected to keep track of expiration dates and report them; proactively place manual resupply orders as needed; and keep track of the automatic resupply scheme for each protocol—all while juggling several trials simultaneously for several sponsors that are contracted with several different lab kit vendors. 

Between juggling ambitious commitments to sustainability, overinflated study budgets, and frustrated sites, sponsors have a lot at stake when it comes to proper supply management. But understandably, many sponsors feel that supply waste is better than the opposite problem—having insufficient supplies on site for a patient visit. This scenario could result in missed collections, a protocol-deviant late collection, or worse—a precious sample that is lost or rendered useless because the site tries (and fails) to piece together a lab kit with their own supplies.

While these concerns are valid, it’s important to consider how oversupply can actually exacerbate site compliance with inventory management. The more physical lab kits and bulk supplies that a site is forced to manage, the more likely they are to lose important supplies in their facilities, lack visibility to on-hand inventory quantities, or monitor expiration dates. These risks are only made worse by the fact that most sites rely on paper and spreadsheets to manage their study supplies.

Where does monitoring come in?

The primary purpose of monitoring is to maximize the completeness and accuracy of reported data, as well as ensuring that study conduct complies with the most current versions of study documents. When sponsors enhance their ability to monitor and regulate lab kit inventory — and couple that with site enablement tools that standardize site processes for managing inventory and improve their compliance with inventory management — the result is better compliance with study documents and higher quality data. Sites always have the supplies they need on hand, and are less likely to lose track of on-hand inventory or expiration dates.

However, it’s important to also acknowledge the return on investment that comes with deploying a more robust monitoring strategy for clinical inventory. By using automation and site enablement tools to enable more precise inventory management, sponsors can also save thousands or millions of dollars on lab kit waste — not only keeping their studies on budget, but reaffirming their larger-scale commitments to sustainability.

Embrace sustainability—and save thousands doing so

Clinical supply waste doesn’t have to be inevitable, and neither does a missed collection or a lost sample. Slope’s clinical trial execution platform includes an inventory management system that prioritizes the interests of sponsors and research sites alike. 

Slope serves as a comprehensive solution for minimizing physical waste by ensuring that sites are supplied with the right inventory at the right time. Using our proprietary software, sites can track inbound and outbound kit shipments, track on-hand inventory (including on-site storage locations), monitor expiration dates, and more. Sponsors also have more real-time, accurate visibility to inventory data, enabling them to manage resupply orders more efficiently based on actual site usage rather than forecasting. The result is reduced burden on site coordinators, a manageable study budget, and a timely, reliable sample collection.

Speak to an expert today about how Slope reduces lab kit and supply waste, or check out this case study about how Slope helped a cancer center cut inventory waste.

To explore the other ways in which today’s clinical trial landscape is hindering sponsor monitoring strategies and research site compliance, check out our guide, "Dissecting the Link Between Clinical Trial Monitoring and Research Site Compliance."

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