What’s Behind Slope’s New Tech-Enabled Services? A Q&A with Slope’s VP of Biospecimen Data & Operations, Mark Melton
In case you missed it, Slope recently announced the launch of its tech-enabled services, which are designed to revolutionize biospecimen lifecycle management in clinical trials. By coupling the Biospecimen360™ software with expertise in biospecimen operations and data management, Slope’s Professional Services turn raw sample data into actionable insights that drive quicker, better decisions from study startup to closeout.
To help sponsors learn more about these services, we sat down with Mark Melton, Slope’s Vice President of Biospecimen Data and Operations, to understand why these services came to be, how Slope’s services support the entire biospecimen lifecycle, and what these services mean for clinical research as a whole.
What inspired the development of Slope's tech-enabled services, and how do they differ from the support already provided with Slope’s Biospecimen360™ software?
The tech-enabled services were inspired by a need I observed even before joining Slope, based on my experience building out biospecimen operations and sample management functions at CROs and sponsors. A key challenge was that, although there were smart people capable of managing these operations, they were limited by the tools and data available to them.
In many cases, we were just aggregating data on the back end, using decent SaaS tools for reporting and aggregation, but it always felt like we were late to the problem. Instead of making progress to solve issues, we were just managing them.
What excited me about Slope was the opportunity to control data inputs on the front end. This shifts us from simply managing problems to preventing them. By combining a tool like Biospecimen360™ with skilled professionals who support lab and biospecimen operations, sample tracking, and biospecimen data management, we can stop issues before they happen, rather than just watching them unfold.
Can you walk us through a typical use case where Slope’s lab and biospecimen operations expertise can significantly impact trial efficiency and sample quality?
For too long, the industry has been compartmentalized into areas that were necessary and the ones that aren't. The biggest thing I could say to anyone looking at where we're at with the rise of precision-based medicine — biomarker operations, bioanalytical operations, lab operations, biospecimen operations — what we need to recognize is one key factor: structure dictates function.
What that means is we need to understand the operational structure of the lab; how it interacts with other labs; how long it takes to produce kits and accession samples; how their LIMS functions; and what their SOPs say and allow them to do. All of this impacts data output, how your trial runs, how quickly your specimens are tested, and what happens if there’s an issue with the specimen. None of this is fully standardized, even though some common themes do exist.
Slope’s job is to ensure that data isn't just analyzed in isolation. Instead, we consider where the data came from and how the source functions. Our team of experts understands the differences between various labs. Each has its own challenges, especially when dealing with different types of samples, such as CDx samples and prospective testing versus retrospective testing samples.
The key is to bridge that gap between these operational differences. One of the biggest challenges right now is accounting for the interdependencies. When you select multiple CROs and lab vendors (and even if one company owns multiple labs, they’re still separate entities), how do you manage the interdependencies between all these groups? Our team ensures everyone is on the same page, understands their roles, and knows how the trial is supposed to function.
Biospecimen data management can be particularly complex in large-scale and/or sample-intensive clinical trials. How do Slope’s services help sponsors ensure data integrity and meet protocol endpoints?
It’s widely recognized in the industry that not all data are alike. One key distinction is understanding how the data are generated, as there's a big difference between systems like EDC and LIMS — in how they report, function, and are maintained.
Traditionally, clinical data managers primarily worked with EDC — building and maintaining the eCRFs and ensuring data integrity. But with the rise of external data, it has become critical to track and ensure that wherever a sample touches, the associated data maintains its integrity. Whether you're talking about labs or databases, discrepancies must be avoided to ensure everything matches correctly.
At Slope, we leverage our sample data management services in tandem with our software to control the inputs of the data, not just aggregate the outputs. Additionally, by conducting reconciliation on all data sources reporting on sample metadata (i.e. Biospecimen360™, eCRFs, LIMS, etc.) and tracking discrepancies, sponsors can confidently know that the sample and its corresponding data are accurate.
What operational insights can sponsors gain from Slope's end-to-end sample tracking support, and how does it augment what's already done in the Biospecimen360™ software?
The reason we call these "tech-enabled" services is because they truly are. Traditionally, when a sample is shipped, all you get is a tracking number, but you don’t know what's inside that shipment. We control the shipping, so our experts are able to track every sample and compare the data between different points in the lifecycle. For example, when samples reach labs, we can ingest the data, compare it to expected outcomes, and confirm whether everything is accounted for and processed correctly.
This process allows us to ensure that all samples are handled according to the protocol, and we can report back that everything has been generated and accounted for accurately. And because this can be done as soon as the data becomes available, the only limiting factor is how quickly and accurately the lab provides that data.
Additionally, Slope can provide vendor report cards, similar to how clinical operations measure site performance. No one typically holds vendors to the same standards, but we can. For instance, if a vendor says they can process samples in 3-5 days, but we get the data 7 days later with 15% errors, we can highlight that. It’s not just about tracking where your samples are; it's about ensuring the integrity of the entire sample logistics process and holding everyone accountable.
How do you see these tech-enabled services helping sponsors not only optimize their biospecimen data but also make better, faster decisions during their trials?
Slope’s approach controls the creation and export of data, as well as the physical movement of samples alongside their data. This dramatically reduces the queries and discrepancies you’d normally encounter. When you add our expertise in sample tracking and data reconciliation, we can either replace or enhance your existing process, transitioning from something that might be handled monthly to weekly, with organized reporting and clear metrics.
Additionally, our tech-enabled services offer a level of monitoring that hasn't been possible before. We're the first to connect the dots between external sites, inventory, and sample shipping, allowing sponsors to monitor trial progress more closely. This results in faster study completion times, as our team helps you operationalize your data in Biospecimen360™ to glean insights into whether your processes are working or need adjustment. Furthermore, our software and services combined allow you to analyze complex biomarker strategies or challenging sample types with actionable data, letting sponsors make more informed decisions about their protocols.
Finally, our services bridge gaps between operational and scientific teams. Both groups want the same thing but often approach it differently. Our data platform, combined with our expert services, helps unify their efforts, enabling teams to make decisions together more effectively. This improves communication and collaboration, making the trial process smoother and more efficient.
Learn more about Slope Professional Services
To learn more about how Slope’s Professional Services can take your clinical trials to the next level, check out our press release and download our info sheet to explore the full range of services we offer. When you’re ready, click here to speak with an expert.
