CWWeekly presents this biweekly feature as a spotlight on issues that executives in clinical research face. This week, writer Suz Redfearn spoke with Ryan Jones, co-founder and CEO of Florence Healthcare, which focuses on site-centric document management.
Q: What are your thoughts on the evolution of technology at the site level?
A: I was previously in document management at Microsoft. When I left the company, I wanted to focus on something meaningful. I met a doctor at Emory who shared with me that doctors and nurses working in research didn’t have tools built for their needs. Instead they worked with tools built with the sponsors’ needs in mind. I learned that the biggest issue at sites stemmed from document management—something I had enough experience to explore.
When I launched Florence Healthcare, the entire first year was spent talking to 250 trial sites around the world to get multiple perspectives. What I found was a progression of technology, but it has largely been limited to finances. People want to get paid, so they found technology to help. In the world of clinical research, that involves clinical trial management systems (CTMS). CTMS help the billing department, but they don’t do much to help the PIs or coordinators. Sites have more work than they’ve ever had before. Many three-ring binders are piling up, but CTMS software doesn’t help with those.
Sponsors have been focused on a regulatory change called electronic common technical documents (eCTD), which mandate that the master file is delivered electronically to the FDA. There are systems that make paperwork digital for sponsors, and they are sold to just the sponsor. As a result, these systems don’t help sites and sponsors collaborate.
Q: Discuss portals designed to help sponsors and CROs communicate with sites about individual trials.
A: The portals available today can be a lot like the Bay Bridge: half of it is crowded, with lots of traffic going in one direction, but hardly any traffic is going in the opposite direction. The sponsor deploys a portal and hopes sites use it as a focus for their work on the trial. For a multitude of reasons, sites aren’t able to use portals as a platform for their work. Portals only work if both sides see the same things within it, and that isn’t how they were designed. Instead, the sponsor sees one thing and the site sees another. Additionally, many portals only create more work for the site, with coordinators having to go through as many as eight steps just to upload a document about a blood pressure change. That isn’t helping sites.
In order to help the industry, focus needs to be placed on helping sites, not just sponsors. One possibility is to give sites something that looks more like Dropbox, where anyone who logs in sees and has access to the same thing. This is where truly collaborative work can take place. We built a prototype software that saved sites 43% of the time it had previously taken to organize all their work. Sites need a reporting and alert system that enables everyone to see what work needs to be done. Also necessary is digital document editing, which replicates what they’ve done in the physical world. This is faster and more streamlined than those options portals offered sites.
Q: In recent years, are the needs of sites being accounted for?
A: We’re seeing the rise of site influence. That’s because the number of studies have grown so much that the sites are a precious commodity. Couple that with the fact that tool investment has mostly been from the sponsor side, and there’s an imbalance in the industry. It’s like a principle of nature: The water is going to flow downhill at some point. Why not earlier? The timing is just right. Though 70% of sites still use paper, electronic health records (EHRs) are now mandated by the Affordable Care Act. Clinicians are becoming much more comfortable with the software. It’s hard for change to be accepted early on, but the water is starting to run downhill.
This article was reprinted from Volume 20, Issue 17, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »