Buildings are one of the great marvels of human ingenuity. Every man-made structure, from the pyramids of Ancient Egypt to the skyscrapers of today, were the direct result of intricate planning and careful execution.
Despite the amount of work that design and construction requires, modern society has figured out how to successfully build things en masse. Every day, architects, engineers, and construction teams are erecting new highrises in our city centers, new neighborhoods in our suburbs, and new bridges on our roads. What’s even more impressive, though, is that the finished product is almost always structurally sound.
What do all successful construction projects have in common? In short, none of them would be possible without a blueprint. Before a new build even begins, architects and engineers pour countless hours into precise measurements and instructions, laying out exact specifications and procedures for the construction teams. Perhaps the widespread success of our infrastructure can be attributed, at least in part, to the fact that architecture firms have gotten this down to an exact science.
The “blueprint” analogy is so universal that it even comes in handy when we talk about sample tracking in clinical research. Think about the elements that have to be in place in order for sample tracking to even be possible. For starters, samples can’t be collected or tested without the proper supplies to collect and process said samples. Sample tracking also relies heavily on identifiers — including accession numbers, study IDs, visit IDs, patient IDs, and sample IDs. This metadata must carry with the sample throughout its entire journey.
But how are these identifiers associated with a newly collected sample? In most cases, pre-assembled lab kits are assigned to a unique accession number, as well as a specific protocol and visit. Within these lab kits, sample containers are almost always pre-labeled with sample-specific identifiers, making it easy for stakeholders to determine which assays are to be performed on which specimens. And if your lab kits contain requisition forms (as most do), then sponsors and labs rely on these forms to determine patient ID and other critical pieces of sample metadata.
Given the essential role that lab kits play in sample tracking — and therefore study outcomes — what should sponsors consider as they seek to optimize their sample tracking strategy through better lab kit management?
Imagine if you ran an architecture firm, and every single one of your architects on every single one of your projects had their own unique process for creating blueprints. The chaos that would ensue would be detrimental to your business. Projects would never get done efficiently and would be prone to all kinds of risks.
As we explore in this blog, standardized processes lay the foundation for efficiencies and allow administrators to control for various risks. In the case of lab kit management, having a standardized system in place across all sites that are supporting a trial ensures that all study coordinators are performing their basic tasks in the same way, enabling sponsors to keep closer tabs on their inventory. Because sponsors are able to use standardization to optimize their inventory management workflows, they can use this approach to optimize their sample tracking strategy.
Unfortunately, this doesn’t represent the current status quo. Many study coordinators at sites rely on paper and spreadsheets to track lab kit storage locations, on-hand supply quantities, and expiration dates — and each coordinator at a single site may have their own methods for tracking this data. This has the potential to hinder the effectiveness of sample tracking, because samples can’t be monitored unless they are collected and properly assigned to the appropriate identifiers.
In the world of construction, a solid blueprint should have everything the builders need to successfully execute a project.
The same principle applies to inventory management in clinical research. Processes should not only be as consistent as possible within and across research sites, but these workflows should also help site staff execute their responsibilities more accurately and efficiently.
For instance, a sufficient inventory management blueprint should enable sites to keep better tabs on expiration dates, storage locations, and on-hand inventory quantities. This not only eliminates the risk of patients being turned away or rescheduled due to inventory, but it greatly improves the likelihood that all of the appropriate samples and sample metadata is captured for sample tracking purposes.
In construction, blueprints define both the materials needed for a project and the physical placement of those materials. This logic is easy to follow, because you can’t determine where or how to install materials in a new build unless you define what the materials are first.
So why do we treat lab kit management and sample management as separate workflows, when one can’t exist without the other? As we explored in this blog, the relationship between clinical inventory management and sample management is synergistic in nature.
To that end, when sponsors are evaluating the best solution for sample tracking, they should only consider options that also enable inventory management. Given the fact that several sample identifiers are directly tied to the lab kit and its various components — including accession numbers, visit ID, and sample-specific container IDs — it’s important to ensure that this data carries with the sample throughout the remainder of its journey.
Click here to check out our comprehensive guide on sample tracking
Unlike other point solutions for sample tracking, Slope's Biospecimen360™ software is your one-stop shop for managing all of your clinical inventory and patient samples. We give your sites the tools they need to manage your lab kits efficiently and accurately, thereby enabling site staff, CRAs, and sponsors to monitor on-hand supply quantities, storage locations, and expiration dates in real time.
Slope pre-configures your lab kits and lab manuals in the platform so that when sites are ready to use a kit for your study, they simply use our guided workflows to facilitate sample collection, processing, storage, and shipment using the supplies within each visit-specific kit. By using Biospecimen360™ for both inventory and sample management, the platform automatically updates the site’s inventory data, while also laying the groundwork for samples to be tracked from the site to various labs and biorepositories.
To learn more about how Slope can transform your trials, click here to speak with one of our experts.