Veeva Systems VP of R&D Strategies Discusses Ways Companies Can Improve Collaborations with Research Sites

ACT: How can companies establish strategies to improve collaboration with research sites?

Reilly: Collaboration with research sites is a passion area of mine. I think we have two different frequencies that were on the research side and the sponsor side. But historically, you have two different frequencies. One side is not really connecting clearly with the other. What I mean by that, is that research sites are where the research happens, right, that's where the patients are seen, that's where the data is collected. They're the ones that are using the tooling to engage with the patients, and to make sure the right data is being collected, not the sponsor. That means they have to use the technology that a sponsor has selected for their trial. In the backdrop of that, is the fact that more and more tools and technologies are being added to the fray of trials, because of the way trials are getting more sophisticated. There are more data sources, and therefore even more tools than there have ever had been before. Not just the EDC, you know, not just the lab data, but you've got streaming data from wearables, data coming from imaging solutions, E pros and E CLIN rows, and the list goes on and on.

What we're doing is adding a technology burden to the sites who were already concerned with the burden that they were holding up, because there is no one solution. So, they use a AEDC from this sponsor BEDC from that one and CEDC for that one. If you replicate that challenge across sponsors and across technologies, it's not uncommon for one research site to be using dozens of tools, and that doesn't seem right. Using dozens of tools to get a trial done right and to work with the patient the way you want to.

I think that what we have here is, again, there's a there's a frequency misalignment, and I think the way to solve for it is just to get a little bit more connected and simplified with our technology footprint on the sponsor side, so that they are bringing less technology to the sites and solving some of the big challenges like user identification. Not having, you know, a sponsor a ID sponsor, bi D, a sponsor, CID, but how about having one Id across my research sites, across sponsors that they can use effectively, so they don't have to manage passwords for, you know, dozens of applications.

These are examples of things that I think need more of a strategic focus in the in the technology community, in the sponsor community, in solving for a simplification strategy of tech with sites. I think the other way that we can improve things is beyond the technology. There's a real problem with site understaffing and not being able to see as many patients as they'd like to see. How can our industry counterparts help in that regard? I know of a sponsor, for instance, that is running a post grad placement program of new grads that can join the site community, and become clinical research coordinators or site staff so that we can keep the funnel alive and make sure that sites have the right skill resource they need.

ACT: What does the year ahead hold for clinical trials and what are some key areas of opportunity for the industry?

Reilly: I sort of alluded to the fact that, you know, the science has only be become more sophisticated. We've had to keep up with that by adding more sophistication to our enterprise, our people, our structure, and certainly our technology on the sponsor side. What's happened with that, is that it's sort of gone a bit unchecked and now we're left with a lot of technology, a lot of new process, and not a lot of connection happening. I think that where the real emphasis is going and has to happen this year, is in that notion of simplifying or rethinking my process to align with new trial modalities. Then, rethinking and updating In my technology strategy, so I simplify the number of systems that I have to use and brings and by the way, bring to research sites and patients and wherever I have disparate technology to make sure that I have a connected data flow, because so much of the time and investment that goes into trials these days, especially on the tech side is in in a custom way integrating things or replicating data. We need to have more of an end to end and simpler data flow, not a disconnected, more complex one.