Rethinking Operational Models to Reduce Site Burden in 2026

In a recent video interview with Applied Clinical Trials, Kevin Williams, EVP and Chief Strategy Officer at Ledger Run, discussed how sponsors must rethink operational strategies in 2026 to better support clinical trial sites amid rising complexity. He explained why sourcing models, system design, and workflow automation must be evaluated together to reduce operational switching and site burden. Williams also outlined how sponsors can introduce new engagement tools without overwhelming sites, emphasizing neutrality-first adoption and consistency across processes. He explored how AI-enabled workflows can automate existing processes rather than impose new ones, and concluded by identifying the metrics sponsors and CROs should track to assess whether site support investments are improving performance, satisfaction, and long-term collaboration.

The below interview transcript was lightly edited for clarity.

ACT: What key operational changes are needed in 2026 to truly support sites rather than overwhelm them with new tools or processes?

Williams: Yeah, I think from an operational perspective, it depends what aspects you’re looking for. On the trials, there could be a number of things that could contribute to different changes. I think one of the key things that people look at is, one, how do I deliver the service? So is that a functional standardization?

In our particular space, it’s usually, do I source it to CROs, or to multiple CROs, or do I use a more functional model? So when you think about operational changes, do I change my approach functionally to do it? And then I think the other component of that is, do I change my systems or applications, or is there a better way to do it? And those two things aren’t mutually exclusive. It may, in fact, be a combination.

What we’ve definitely seen is that sponsors are exploring different ways in how they approach their utilization of CROs and other service providers. We’ve definitely seen a trend toward bringing things in house. And what does in house mean? Does in house mean functional sourcing, or does it mean a new system, or some combination of both?

I think the other key thing on that is really related to operational switching, and I’ll talk about that a little bit later too. Sites traditionally have challenges working with a lot of different sponsors and CROs. Whether it’s different processes from one sponsor to the next, or different systems, they deal with a lot of switching burden—having to log into different systems and things like that. So those are things that people need to be aware of when making choices about changes.