In this Q&A, Cheryl Kole, vice president of solution strategy and commercialization at Almac Clinical Technologies, examines what it takes to build and sustain a clinical trial technology infrastructure that can keep pace with increasingly complex study designs.
Watch parts of the full video interview with Cheryl Kole on the Applied Clinical Trials YouTube channel, where she goes deeper on eClinical ecosystem design, supply chain integration, and what it takes to build technology that truly supports site teams. Subscribe for more expert conversations shaping the future of clinical operations and drug development.
As clinical trials grow more adaptive and decentralized, the pressure on technology infrastructure to perform seamlessly across sites, supply chains, and study teams has never been greater. To explore this further, Applied Clinical Trials spoke with Cheryl Kole, vice president of solution strategy and commercialization at Almac Clinical Technologies, about the gaps in current eClinical ecosystems, the underappreciated role of usability, and how sponsors should be thinking about evolving their tech stack for the trials ahead.
Kole: I think effective technology, in its simplest form, means that you have these tools and they need to work together to simplify the execution of the clinical trial. These tools are supposed to help us. It's supposed to feel easy and guide us through all of the different tasks and things we need to do to conduct clinical research.
It also needs to be purpose built. What I mean by that is it has to be specialized in the different research activities that are occurring—randomization, supply management, eConsent, patient reported outcomes. There are so many things that are part of conducting clinical research, so the tools have to be focused on the tasks at hand.
And with that, trials are different. Things are ever evolving. One trial can be very different from the next. So the technology has to account for those differences. Configuration is extremely important, but it's not just configuration. It also has to provide workflow guidance and guide users through the technology, providing different guardrails and logic along the way. That's what's going to ensure both the quality and the compliance in carrying out those tasks.
You're going to have multiple tools that need to be purpose built, and that means you need an integrated ecosystem that allows users to work efficiently and help them make effective decisions. Ultimately, an effective tech stack is going to simplify the complexities of running that clinical trial.
Kole: I think technology can sometimes be too heavily focused on the systems and the data flow, and maybe not enough on how people work day to day. The biggest gap is really coming back to what I said previously—having the technology truly help users and guide them through what they need to do day by day.
Each trial is going to have its own workflows and its own systems, but oftentimes there's nothing telling a user what to do next. Think about sites—they're very busy, they may be working on multiple trials across various sponsors, and they have a patient in front of them. They're relying on their memory, or maybe some written notes or a handbook to show them what to do.
The gap in technology is something that can really take the user and guide them through that workflow. For a given trial, for this patient, I need to do this now. I need to log into this integrated response technology (IRT), then log into this electronic data capture—tailored to that trial specifically. That would really help reduce the cognitive load of having to remember, relying on sticky notes, even simple things like sign-ons. We all struggle with that every day. Compound that for a site running multiple trials, and if they had something that just said, okay, go here, log in here, click this button—truly end to end—I think that is the biggest gap. If we could implement a fully digitized workflow management system, that would really help site engagement, data quality, and overall study outcomes.
Kole: The digital and physical supply chain really is one continuous system flow, and it has to be treated as such. You really can't handle those things as two separate entities.
All trials today are using some aspects of digital supply chain management—even something as simple as placing a drug order online, or an IRT using automated drug ordering feeds into supplier systems to kick off the physical activities of picking, packing, and shipping. Those things are very common today, and these systems have gotten very sophisticated. They support all different types of supply chain designs, protocol designs, decentralized trials. There's really a lot of power in digital supply chain management that supports the physical activities that have to happen.
But with that, it can be complex. So as a sponsor, you have to understand your own capabilities. Do you have strong supply chain management expertise in house, or is that something you need to outsource? Do you need to partner with your technology provider to understand how to set up the system, configure it, and plan how to use it during the course of the trial?
Because supply chain management at the beginning is often relying on assumptions—enrollment is going to go a certain speed, certain countries are going to have different activity. But during the course of the trial, when you see actual patient populations, that's when you need to adjust. The power comes from having real time information on site and patient performance, and always being able to deal with the unexpected—a stock-out situation, a lot failure.
Understanding your needs and capabilities, and leveraging your technology partner, is the most important thing. With the right implementation and use, it really helps with efficient supply management and enables you to control costs, quality, and patient safety.
Kole: Usability is extremely important, both for adoption and study performance. If a system is easy to use, users are willing to use it more often. They're not going to look for a workaround or put it off until the last minute. That leads to more confidence in the user. If it's easy to use, they can get in quickly, do what they need to do, and log out. They don't have to go look up a user manual, which leads to fewer mistakes and better data quality.
Sometimes we get so focused on what data needs to be collected and how systems talk to each other that we forget about the actual users and how to set things up for ease of use. We always say, when we go to some other software in our daily life, I don't need a user manual—it's just intuitive. Whereas some systems you have to log into are slow, clunky, and hard to use. So what do you do? You come up with a workaround, or you save it till next week because you can't take the headache of navigating through it.
As a provider of technology, it's so important to remember the user first and how we're setting up these systems. How can I make it very easy to get in and get out? I don't want users spending hours in the technology. All of our users are very busy doing other tasks. I want them to use the technology and have it be fast, simple, and easy—not really thinking too much about it.
Kole: Absolutely—and maybe that is the success of technology. When I think back through my 20-plus years in this industry and the early trials we were running, it's funny to think that at the time I thought those things were complex. Today they're run of the mill, almost very simple. So things that are new and novel today will probably just become the normal for study design in a couple of years.
With that in mind, your technology needs to evolve as protocol designs evolve. Technology is really the enabler for that. Thinking about study adaptations and complexities, some things will become the new normal and become standard, whereas other things will be one-offs—maybe because of a very specific trial design or some constraint in a study where you're doing things a certain way that you don't expect to happen again.
That goes into evolving your technology in a smart way. What is going to be repeatable? What do I need to do time and time again? That's what I want to build into my product as innovation and evolution. Versus what is just a one-off—I'm not going to put that in the technology. I'm going to manage that specifically as a bespoke build in the software.
That's important both as a software vendor and when partnering with sponsors—explaining the difference. Because your technology can become overburdened with too many configurations and too many choices. We need to keep it streamlined, but we also need to support both the standard repeatable within a technology product and the one-off that can be custom built and set up as needed.
