August 15, 2023

Introducing the Beta Launch of Sample Management for Sites: A Conversation with Slope Co-Founder and CTO Michael Felix

“There is a much better way to do your day-to-day.”

This is Slope’s core message to clinical research sites, according to Co-Founder and Chief Technology Officer Michael Felix. Slope was founded on the notion that the status quo for clinical trial execution is hindering stakeholders, undermining data integrity, and jeopardizing the patient experience. As study designs become increasingly complex, manual processes and incongruent workflows are becoming more inefficient and prone to error. Clinical research sites find themselves at the center of this dysfunction, as they are tasked with balancing patient care with inventory management, sample logistics, and reconciliation. 

Slope has created a solution that directly addresses these site-specific pain points, and we’ve empowered sites to adopt these solutions themselves. As we discussed in a recent blog, inventory management lays the foundation for sample management, and clinical research sites should be key players in optimizing the success of these symbiotic workflows. This core principle is the premise of Slope’s sample management for sites platform, which launches its public beta on August 15th. This functionality has been available to sponsors since 2019, but the ability for sites to perform sample management independently, across all of their studies, has not been possible until now.

For this week’s blog, we sat down with Michael Felix to discuss how sample management for sites came to be, how the platform works, and his hopes for the public beta launch.


What prompted Slope to create sample management for sites? Walk me through that story.

Michael Felix

The initial “aha” moment emerged from ethnographic research, which revealed that clinical research sites didn’t have the tools they needed to manage their lab kits and supplies. Slope created an app in 2018 that confirmed sites’ eagerness to track their clinical inventory when given the right tools. Sponsors were also interested in our inventory management capabilities, but they wanted us to apply a similar framework to managing patient samples. This is where we derived our core insight that inventory management and sample management are one cohesive ecosystem, with every kit becoming one or more samples.

We initially built a tool that would allow sponsors to manage samples for studies that were running on Slope. It connected to our inventory management component, but we could only deliver a comprehensive experience if we were working directly with the sponsor. Sites really loved the solution, but when we implemented Slope’s sample management platform at a site for one study, they asked if we could implement this solution on their other studies. 

About a year ago, we began the quest of translating standard site processes into actionable steps in our platform. After consulting several clinical research sites—from small, community-based operations, to massive AMCs and site networks—we obtained valuable feedback, including the need for guided workflows that break down the lab manual step-by-step and document chain of custody. Our team built out an inventory configuration tool and extended its utility so that Slope could adapt to all of the nuanced requirements that sites were being asked to comply with. From that, we launched a private beta that enabled us to successfully register over 2000 samples. Our public beta is currently underway. 


How would you summarize the feedback that you received from the private beta?

Michael Felix

We saw people go through a process that I call “getting Sloped.” People realized that there's a better way to do things that didn't exist before Slope came into their world. We’ve seen significant adoption of this tool because we took a lot of time to address site-specific challenges and design to their needs. Site users have expressed gratitude to Slope for making their lives easier and ultimately benefiting patients.

In engaging with users, we’ve also found that by investing some time up front in configuring inventory and sample workflows, sites are able to save time and resources on downstream processes because they’re not performing redundant actions every time they’re performing a given workflow. 


What is the purpose of the public beta?

Michael Felix

Our goal is to nail down the best possible sample management for sites experience. We’ve already seen some of the most complex and unique kit and sample configurations in our platform, and are thrilled to see even more. For example, we recently had a site reach out about a lab kit that had a ton of different components inside of it, and this kit got split up into single components from there. Our team spent time going in and addressing that constraint. 

Oncology is one therapeutic area that we’re really focused on because that's where we tend to see some of the most complex study designs, but we would love to see all different types of studies participate. Large phase III studies are also good candidates due to the large volume of samples that we tend to see on those programs.


What is the core message you are trying to convey to site users about Slope’s sample management for sites solution?

Michael Felix

There is a much better way to do your day-to-day. We've spent the last two years nailing down what that way is, all while improving it and de-risking it. Just think about how easy it is to see how many stops away your Amazon package is. That’s convenient, but imagine if that same level of real-time visibility was applied to precious biospecimens—like blood from a pediatric study, or tissue biopsies from an oncology study. We've invested a lot of time in this solution, and we’re setting out to prove to everybody that our clinical trial execution platform is the unparalleled solution to an unjustifiable problem. 

We've invested a lot of time in this solution, and we’re setting out to prove to everybody that our clinical trial execution platform is the unparalleled solution to an unjustifiable problem. 

Sometimes it feels like clinical trials are haphazardly glued together with paper and spreadsheets. I go to sites and watch people do so much paperwork, only for them to have to manually sift through documentation every time their CRA contacts them with a query, or every time they need to reference training materials. And that’s just the beginning. What does it feel like to have dozens of samples in front of you that have to go to four different labs? What does it feel like to have countless tools that you have to cobble together across all of your trials? This is what a normal day looks like at most clinical research sites, but it doesn’t have to be that way.


Can you explain the three main workflows of sample management for sites?

Michael Felix

It’s important to note that the predicate to sample management for sites is inventory management. If you're a site and you have kits for a study, those kits need to be cataloged inside Slope. 

Once your inventory management system is in place, the first workflow for sample management is what we call kit configuration; this is where you can take the components in a lab kit, map those components in Slope, and tell Slope all of the specific details around sample handling, storage,  and shipping—such as defining collection tubes versus return tubes, where the return tubes need to be shipped, how samples are stored, and more.

Once your configuration is set up, the next step is collecting and registering samples. Slope will guide you through the steps that you configured to ensure that samples are collected and data is captured as dictated by the lab manual and the sponsor.

The final workflow is sample shipping. Some samples are shipped the day of collection, while others are shipped in batches. There are many possible shipping configurations, but we’ve designed a flexible way for sites to keep track of the samples they’ve stored after collection, while also maintaining visibility to the samples that have already been shipped.


How easy is it for sites to start using Slope’s sample management platform, and what would your message be to those who are considering it but don’t feel like they have the time to set it up?

Michael Felix

Humans have proven that if you keep doing things the old way and don't constantly optimize your processes, then you eventually stunt your own growth. I think the only way to grow is to adopt the best and most user-friendly tools that you can. It’s your choice. Are you going to deal with a kit storage room that's full of supplies and is only going to get bigger? Sites are not supposed to be Amazon fulfillment centers, but they are treated as such. At what point do you invest effort into fixing that? And what is the outcome of spending some time and effort up front? In our industry, the organizations that have adopted tools like Slope will have the upper hand because they will have the proven ability to perform at a higher level.

Clinical research sites are loving our sample management platform so far. As of early August, our site-led platform is supporting nearly two dozen active studies, over half of which are in the oncology space. One site has used the platform to register over 300 samples for 5 patients. In total, we’ve facilitated nearly 200 successful sample shipments.


Where do you expect sample management for sites to be in a year?

Michael Felix

I expect the sample management tool to be at the same level of sophistication as the inventory management tool because I believe it will spread like wildfire once people start to apply it at scale. I think we will see even more sites requesting that their sponsors adopt Slope on their studies. What you see in the beta will only get markedly better within a year, with expanded mobile capabilities and barcode integrations. And within a few years, our hope is that Slope will be expected on most trials.

We are encouraging current Slope users at clinical research sites, as well as prospective site users, to participate. Your data and feedback will be invaluable in helping us perfect the platform in anticipation of our full-scale launch of the product later this year.

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