From Chaos to Compliance: Transforming Clinical Trial Monitoring through Advanced Lab Kit Management

Clinical operations professionals are always looking for ways to finetune their monitoring strategies. As we evaluate the entire clinical trial lifecycle for gaps and opportunities for optimization, we tend to look at the workflows that have the greatest impact on study outcomes — the processes that directly influence the integrity of study data.

One challenge that has long plagued sponsors and research sites alike is the management of lab kits. These kits contain the essential components for collecting biospecimens, but historically the process of ordering and maintaining clinical inventory has been fraught with inefficiencies, inaccuracies, and logistical hurdles that lead to data discrepancies, protocol deviations, study delays, and patient burden.

If you have worked in clinical operations at a sponsor organization, consider the number of times in your career you have been frantically contacted by a research site or a CRA who needs help expediting a critical lab kit at the last minute. Consider the number of times your sites have had to pull a lab kit designated for another visit or another study — or perhaps even built their own lab kits from scratch. Consider the number of times those so-called “workarounds” for insufficient inventory have wreaked havoc in the form of queries, sample recollection events, data exclusion, or even forced patient dropouts. These events happen far too often, and in many cases they can be directly tied to inventory mismanagement.

Fortunately, with the advent of innovative technology, the tide is turning. Sponsors are discovering new ways to streamline inventory processes and enhance oversight capabilities by integrating more robust lab kit management solutions into their monitoring strategies. So why should you implement these same practices in your own trials?

Making sense of the symbiotic relationship between inventory oversight and data integrity

In order to understand why you should incorporate a robust lab kit management solution into your monitoring plan, it’s important to acknowledge the fundamental role that lab kits play in the clinical trial ecosystem. Each kit contains the necessary materials for collecting and processing biospecimens from study participants, functioning as the organizing mechanism behind the downstream management and testing of patient samples. Using a lab kit that has been pre-assembled for a specific visit or a specific collection not only ensures that the site has all of the supplies they need — it also reduces the risk that a site will skip a mandatory collection, mislabel a sample, and more. Lab kits are also often accompanied by requisition forms, which are critical for capturing the biospecimen data needed for downstream sample processing and data reporting. 

Without lab kits, sites are unable to properly collect the samples and biospecimen data needed in order to produce high-quality study data. But despite its significance, clinical inventory is not often prioritized for monitoring, as it tends to be overshadowed by more visible aspects of study conduct. 

Traditional inventory management practices are broken. Can we fix them?

Unfortunately, without robust inventory management processes in place, sites are more likely to improperly manage their lab kits — putting downstream study deliverables at risk. Consider the fact that most research sites rely on paper, spreadsheets, and unstandardized methods to manage their clinical inventory. Not only does this make it more time-consuming to track on-hand quantities, expiration dates, resupply orders, and storage locations, but manually monitoring this data introduces serious risks.

Consider the fact that sites may not be automatically alerted when inventory for a certain lab kit is low or when a lab kit expires. Site staff may accidentally overlook these critical inventory events, meaning they may not become aware that they have insufficient inventory for a patient visit until it is too late. 

At the opposite extreme, sites may over-order lab kits as a direct result of not having comprehensive visibility to their clinical inventory. This can be costly for sponsors, who are often used to seeing at least 50-70% of the lab kits produced for their trials completely go to waste. This in turn clogs site storage facilities, inflates study budgets, and puts clinical trial sustainability goals at risk.

All told, outdated processes for managing lab kits create the perfect storm for risks and inefficiencies on a clinical trial. Sponsors may have limited tools available to them that purport to enable clinical inventory monitoring and automatic resupply, but these tools are often inaccurate and limited in their capabilities. For instance, consider the fact that sites may not report their expired, lost, and damaged lab kits to their kitting vendors; this renders automatic resupply less effective and gives sponsors an inaccurate picture of the inventory at each of their sites.

Optimized inventory processes can directly contribute to improved study outcomes

Sophisticated software platforms have revolutionized the way sponsors and research sites track and manage inventory throughout the study lifecycle. By leveraging automation, real-time tracking, and more precise data-driven resupply, these solutions offer a comprehensive toolkit for addressing the myriad challenges associated with lab kit logistics.

One of the primary benefits of advanced lab kit management is its ability to bring order to chaos. Gone are the days of manual, paper-based record-keeping, Excel spreadsheets, and inconsistent inventory management processes. With centralized databases that track expiration dates and low inventory levels, sponsors can now gain unprecedented visibility to their lab kit inventory. 

When sponsors equip sites with the tools they need to better execute the work of a clinical trial and improve their own monitoring capabilities, study outcomes are dramatically improved. Sites are less prone to deviations, meaning more patients are successfully screened and retained, data is cleaner, and study stakeholders save hours on various tasks — from inventory management to data reconciliation.

Proactive lab kit management is what’s missing from your risk-based monitoring strategy. Slope can help with that.

A comprehensive monitoring plan should mitigate all of the risks on your trial — especially the ones that are directly tied to study outcomes and data integrity. Slope’s biospecimen lifecycle software, Biospecimen360™, includes a best-in-its-class inventory management system that enables sites to drastically improve and standardize their processes for managing their lab kits, while offering sponsors a more accurate, real-time view of the clinical inventory at all of their sites. Biospecimen360™ tracks on-hand quantities, expiration dates, storage locations, and resupply orders in real-time, triggering alerts to site users as needed so that they are better prepared for their patient visits.

Sponsors also gain enhanced visibility to the clinical inventory across all of their sites. The Biospecimen360™ platform automatically updates a site’s inventory numbers anytime a lab kit is pulled for a patient visit or anytime a lab kit expires, enabling more accurate and real-time visibility to inventory data. Biospecimen360™ also enables sponsors to monitor lab kit waste metrics, saving large, complex studies 6 or 7 figures on supply waste. 

Speak to an expert today about how Slope reduces lab kit and supply waste, or check out this case study about how an NCI-designated cancer center successfully curtailed inventory chaos with Slope.

Interested in learning more about the ways in which today’s clinical trial landscape is hindering sponsor monitoring strategies and research site compliance? Click here to explore the innovative strategies that sponsors can implement to strengthen their clinical trial monitoring plans, thereby preventing and mitigating common compliance issues.