Putting Sites First: The eSource Revolution

Sit down with Rick Ward, Chief Commercial Officer at CRIO, to discuss the emerging concept of central eSource in clinical research. Rick explains how this model, which builds on the traditional eSource framework, can enhance standardization, streamline data collection, and reduce the burden of manual transcription. The conversation highlights the importance of site-driven technology, the flexibility required for real-world implementation, and the need for strong support infrastructure. Explore how CRIO’s approach is reshaping source documentation and creating new opportunities for both sites and sponsors.

Transcript

Jimmy Bechtel: 0:07

Welcome to SCRS talks provided by the Society for Clinical Research Sites. Thank you for joining us as we explore the latest insights, trends, and innovations shaping clinical research today. I'm Jimmy Bechtel, the Vice President of Site Engagement with the Society, and today I'm joined by Rick Ward, the Chief Commercial Officer with CRIO. Rick's here to talk with us about the concept of central eSource and how eSource is really changing and evolving as the industry continues to evolve. Rick, great to have you. Really excited to talk about this relatively novel concept on a longstanding piece of technology we've had in the industry. But before we jump into that if you wouldn't mind, deepen your introduction for us and love to learn a little bit more about you and CRIO.

Rick Ward: 0:55

Absolutely, Jimmy. Thanks for having me. I appreciate the time. Look forward to the conversation. As you mentioned, I'm Chief Commercial Officer at CRIO. Actually joined the organization just about six months ago, but I've been working in the clinical trial space for.. little over two decades. Last 10 plus years really helping to drive commercial growth and spread the word for various leading eClinical solutions. So I know many of your listeners are probably familiar with Green Fire. I was one of the very early employees at Green Fire, and that's back when I also first was introduced to SCRS. Also worked for a few other companies, CluePoints, Trifecta Clinical before I joined CRIO this past fall. And that's provided me a nice view of what it takes in this industry to take a good idea, a concept, especially one that's technology based and help socialize it across the industry, hopefully with the intent of improving clinical research and making some of our jobs a little more enjoyable or a little less burdensome. I wasn't super familiar with CRIO prior to joining, but I had seen them at the SCRS summits. Knew that they were well known, especially among leading investigators. But when I learned about their plans to expand eSource to provide this concept of Central eSource, I wanted to learn what that was and the impact it could have. That was kinda all it took for me to get excited and join the organization.

Jimmy Bechtel: 2:19

Yeah, it's great Rick and you have been a long time friend of SCRS in your various roles previously, and it's great to see you with such an awesome and supportive organization as CRIO. CRIOle's been along for the ride with SCRS as well for, several years now, Raymond and the team. So congratulations and really excited to talk about this because as you have stated, and as we've observed, CRIO has really been one of the leaders in the eSource space for a long time, but this concept of central eSource is gonna be probably something none have heard before on the line. And there's probably already a lot of speculation when I mention that word as to what that could mean. But why don't you as kind of the SMEs in this space here, break down what that is and how it might differ a little bit from sort of the traditional eSource model.

Rick Ward: 3:04

Sure. Absolutely. And I know a lot of folks are familiar with the concept of eSource. It certainly is something that the majority of your leading investigators have evolved beyond sort of the paper source and paper process days, and recognizing that by leveraging an eSource tool it assists with protocol compliance. It allows to, sort of streamline the process, foresight staff generally leads to fewer protocol deviations and a, a better audit trail and lots of advantages from the site's perspective. Also some advantages to study sponsors and CROs that maybe were not quite as visible to them. What occurred in the industry over the last couple of years were sponsors recognizing that as the CRIO eSource had sort of been adopted as the standard in the industry, there was a lot of feedback from sponsors saying, we recognize the value that's being brought here. Is there anything else we can do, or how might we partner with sites to leverage this technology in an even more effective way? Because they recognize that for most of their studies, they might have a large swath of their sites that were using CRIO eSource to collect data, but there were also sites that were still perhaps using paper methods or some other eSource tool and they looked at it and saw an opportunity to build some standardization and gain some efficiencies by having a centrally designed source document that could be built and then provided to their sites to further enhance and be consistent with how the data is being collected across their trial. As they explored that and we partnered with a couple of sponsors to further explore exactly how that could be deployed. We've come up with a few meaningful additional values that can be provided to the sponsor. And what's gonna be important to your audience is some enhancements to the experience at the site level that they may have never experienced before. That I think they're gonna be quite excited about.

Jimmy Bechtel: 4:54

That's cool, Rick and I think it is a really interesting concept because you're potentially augmenting the work that the site is doing by giving them an additional resource and a head start I guess with the source collection aspect of things. And I know there's been past attempts to centralize this at the sponsor level. But I'm sure some of the sites on the line have probably also said, huh, that does sound familiar. Or maybe they've seen that before. It hasn't gained a lot of adoption, and I know you guys are taking a different approach. So can you share what's different this time? Why is what CRIO is doing any different or, better than what we've tried to do in the past?

Rick Ward: 5:30

Yeah, that's a great question, Jimmy. And it's really important to look at the historical perspective because yes, there have been attempts to leverage this approach in the past that haven't quite taken foot and I think that there's a few important reasons for it. You mentioned one of our founders, Raymond. It's probably worth noting that CRIO was founded as a site facing solution. It was founded to support the needs of sites and the eSource solution was designed with sites in mind. The most important difference in what CRIO is doing to what has been tried in the past is we're starting with a solution that has been embraced by sites and has been designed to meet the flexible needs of the many different types of investigators out there. First and foremost, starting with a technology solution that is designed for sites is the biggest differentiator in terms of why we believe that this is going to work much more effectively. But there, are a couple of other really important pieces. One of the challenges that was recognized was that although clinical trials are a process that requires standardization, when you look at an EDC template, that EDC template is the same for every single site. There's certain data that just needs to be collected and reported back to the sponsor, but the way in which patients are visiting sites and the way assessments are delivered within the confines of the protocol. There are still various different ways that sites operate. Sites have their own SOPs. Sometimes they gather some information in addition to what might be required by protocol. And so the concept designed, eSource inherently has to have the flexibility to allow sites to comply with what's required. But also meet their own SOPs, which means they need to be able to enhance or modify that central eSource template to their needs. That's one of the two biggest differentiators. The other is even with the proliferation of eSource across our industry, one thing I was shocked to learn was that whether you're using a paper source document or an electronic source document. Most sites are still manually transcribing all of that data over into the EDC, and that's because any typical site is working with multiple sponsors using different EDC systems that are built differently. So there's never an easy way to automate that. When a sponsor gets involved and underwrites the cost and the rollout of an eSource solution. It gives us the ability to build that connection, that integration with the EDC that's being used for that study, and allows us to highly automate the process of moving that data from the eSource solution over to EDC eliminating most of the transcription work, which I'm guessing is not the activity that folks at your sites relish the most and they're happy to be able to highly automate that process instead of handling it entirely manually.

Jimmy Bechtel: 8:22

That's excellent, Rick. There's two things I heard out of there that to me and I hope a lot of our listeners too, really hone in on the point that it sounds like you guys have really been listening to sites because I agree completely with the challenge we've had with eSource has been the rigidity of it with any central solution. The rigidity is what is the root of the challenge so by allowing the flexibility of your central eSource solution to better adhere with the site's, processes and SOPs and what's in the best interest of the patients, is a really critical success factor for how you guys are approaching this. So it's great to hear that. And then again, we've heard for years. That flow of data and the interoperability and the integration of one technology to the other where the data can seamlessly flow from one place to the next. In this case, from the eSource into the EDC has a lot of power and a lot of time savings. And from the sponsored CRO perspective, I imagine a lot of assurance around data integrity and consistency. That's supportive and positive for what we're trying to do here. From a site perspective, Rick, you have alluded to some of the advantages here and if there's any more you wanna showcase, that's great. But, talk a little bit about from the site perspective, again, the biggest advantages, but also potential challenges that we might encounter when adopting some of these eSource models. Centralized.

Rick Ward: 9:42

Yeah, absolutely. The site community, for the most part, has recognized the value of eSource and we're pretty far along the adoption curve there. What I would, point to as some challenges. Some of the things that I've mentioned already in terms of the flexibility and so forth. But something I would encourage sites to consider is that in the broader sense, we've seen this discussion, it's been at the SCRS summits around technology and the sort of two-sided coin of using technology driven by the sponsor, or technology driven by the site. And I think sponsors more than ever before are at a point where they're really seeing the value of adopting technology that is the technology of choice from the site. I think they're recognizing that. Obviously one of the challenges is that in many arenas. The site community has not sort of standardized on any one particular tool, and that's one of the challenges. I think the opportunity here is that we do have an eSource that has the majority of sort of the market of sites that are utilizing an eSource tool. So what I would encourage sites to think about in this process as a challenge is to recognize that we want to kind of meet the sponsors halfway, and that just means have an open mind around the central eSource concept. What the sites are gonna get is access to a tool that has been tried and true for sites, but there's gonna be a slightly different model in terms of the centrally designed eSource template and slightly different way of rolling it out. What I would encourage sites to consider and sponsors as well is when selecting this tool and'cause I imagine at some point other providers may start to explore the same concept we've developed is that the solution itself needs to not only be a very good eSource tool, it needs to not only have all the functionality that you are looking for at your site. But critically important is the support organization behind that solution. And that's really true for any software platform in the clinical trial space. But one thing that I've heard from sites that differentiates CRIO is the degree to which we are able to support with 24 7 live chat and other levels of support. Our site training and enablement team, all the things that we invest into supporting our site community first and foremost. And secondly, to get sponsor programs up and running and successful because many of them involve introducing CRIO eSource to new sites. So the training and onboarding and support of those sites is critically important, and that's what I would encourage sites to do is to recognize that demand, require it, then I think they'll find success with this new model.

Jimmy Bechtel: 12:14

It's great, Rick. I have been telling a lot of that story on stage and to sponsors and CROs for years now, trying to help them understand the best thing that you can do as a sponsor and CRO is adopt solutions that are driven by the sites and that have been able to showcase their ability to incorporate the feedback from the sites. And it sounds like that's exactly what CRIO has done with a lot of their solutions, if not all of them. In particular what we're talking about here, this Central eSource solution, and you've hit the nail on the head to try to emphasize that. This concept of adequate support, technical support, the flexibility of the platform itself, the data flow, integrations that you've been able to build in there. So that's really incredible to hear. And I hope that our sites and sponsors and CROs can listen to and perpetuate some of that. For sponsors then that are looking to consider approaches like this, what are some of the key factors that they should keep in mind to ensure that this adoption by the sites is long-term, but also then long-term successful? How do we make sure that this isn't something that we just is a one and done, or that we we pilot and then move on to something else?

Rick Ward: 13:24

Yeah, that's another good point. So now we're looking at the sponsor perspective and what should their sort of punch list be of things to consider to make sure that moving in this direction is gonna be successful? And there's a few really important ones. But I'll start with kind of the same theme around site adoption. The model that has struggled has been the model when a purely sponsor chosen, sponsor selected solution. Which is also sometimes a technology that was developed purely with the sponsor's needs in mind. When that's the solution you try to roll out to sites, I think you can anticipate pushback and not just pushback for trivial reasons, but very real and significant and important reasons because the workflows that exist within a trial site are variable. And this is the challenge in conducting a clinical trial where you wanna have as little variability as possible. But the reality of it is, as you know, and as your listeners know, no two sites look exactly the same. There's larger sites, smaller sites, there's large site networks, there's independently owned sites there's academic medical centers. There's a lot of different types of sites out there. And if you're going to introduce an eSource solution to support a trial, you really need to make sure that that solution is flexible enough to support all those different types of sites, and that's where starting with a tool that is for the last almost 10 years, been designed and developed and enhanced based on feedback from sites.That I think puts you ahead of the game. So I'm obviously, I'm stumping for CRIO because I know that's the position we're in. But even more generically, I think if you're going to roll any central technology out that is core to site processes, it needs to be something that has been market proven, road proven at the sites and that the sites are embracing it because site adoption is the first barrier that if you can't get past that, you're really kind of dead in the water. There are a few other important considerations. I think one has to do with ability to scale. We've been fortunate enough to have a few partners in the pharma CRO world that have allowed us to support with the central eSource model, both small studies, studies as small as single site or a few sites with just a handful of patients all the way up to very large phase three global programs sponsored by top 10 pharma companies. These are the different types of scenarios that we are supporting. So the ability to scale across different study sizes and different therapeutic areas is also important. I mentioned the importance of support, so certainly sites are gonna be sensitive to the degree to which they get the technical support from a solution provider. I think it's fair for sponsors to take some responsibility there and say, we're not gonna roll a software application or a technology out to sites without assurances that the support organization is going to assist with onboarding, training, and ongoing support. And so if the sponsor's going to be driving a central eSource initiative, they then take on the responsibility to make sure that the technology partner they've selected is providing that level of support to their sites. If that breaks down, the entire process is really less likely to be successful. The other advantage from a sponsor perspective that is new and coincides with the current movement towards more remote monitoring and the ability to reduce monitoring costs and source data verification by implementing a central eSource tool. Allowing sites to use the same technology that they've proven that they like to use for collecting data. But when it's rolled out in a central way, sponsors now have the ability to do remote monitoring. Not a week later when data is entered into the EDC. And believe me, I know many of your sites probably have a much better track record than a week, but in industry standards show that it could be seven to 10 days before data from a visit finds its way into EDC. That's a delay even if the EDC solution provides remote monitoring capabilities. When you have the ability to remotely monitor data, immediately after the patient visit, at the point of collection, you now have that central review capability that you may have never had before. And so in looking at a central eSource solution, you as a sponsor or a CRO would really wanna make sure that central review capability is there, otherwise, you're really missing out on what is potentially a big value proposition for sponsors in the difference between a central eSource rollout as opposed to what we often call local eSource the way eSource is typically used today.

Jimmy Bechtel: 18:11

Wow. Rick, I mean, it's apparent to me that you guys have really embraced and perpetuated this message around solving some of the key challenges at a site level. And that concept of flexibility and an enhanced degree of support is really what we're trying to solve with technology. So it's great to hear that. I'm really excited especially after this conversation to hope and see the direction that this takes as another really positive solution for the industry and something that can help sites augment the work that they do with centralization. So, Rick. Thank you and thank you to the CRIO team. Thanks for being here with us today and having this conversation and helping our listeners deepen their insight into the evolution of source documentation and what the future of this means for the industry.

Rick Ward: 18:55

Absolutely, Jimmy, I appreciate you having me. We value the partnership with SCRS. I'll be heading out to SCRS West in a few weeks and have an opportunity to present at that conference. And of course, I always look forward to the Global Summit. We have other folks from our company going down to the diversity event that's coming up even sooner. There's no better audience, no better venue for us to connect with our community and we use that term community in a very sincere way. As we build these new partnerships with sponsors and CROs we are adamantly dedicated to supporting our community, and it's important that our sites know that even though we are expanding sort of our client base from the site community into the sponsor and CRO world, we recognize that the foundation of our success are the sites that embrace our technology, provide us the kind of feedback we need to keep improving it and ultimately the success of CRIO long-term and the success of this central eSource concept is really gonna land on whether or not it's truly adding value to the site. So again, I appreciate the chance to speak to that community here today, and I look forward to seeing you and many of them at the next big SCRS summit.

Jimmy Bechtel: 20:02

That sounds great, Rick. Yes, thank you. We're looking forward to it as well. And I'd also like to add that for everyone listening, make sure that you don't forget to explore other site focused resources made available to our entire community on our website, my scrs.org. It also showcases opportunities like our site Solutions summits, podcast publications, and webcasts made available throughout the year. Thanks again for listening, tuning in, and until next time.