No More Double Entry: How CRIO and Medidata Are Bridging eSource and EDC for Every Site

Jimmy Bechtel sits down with Kristen Bosse, VP of Product Development at CRIO, and Samir Jain, VP of Product Management at Medidata, to talk about a collaboration that has been a long time coming. Together they break down why eSource to EDC integration has historically been out of reach for dedicated research sites, what has made it so hard to do at scale, and how their joint solution is changing that. They also get into what sites actually gain when manual data transcription is taken off their plate and what the path to getting started looks like for sites running CRIO on Rave today. 

Transcript

Jimmy Bechtel 0:00

Welcome to SCRS talks provided by the Society for Clinical Research Sites. Thank you for joining us as we explore the latest trends, insights, and innovations shaping clinical research today. I'm Jimmy Bechtel, the Chief Site Success Officer at SCRS, and today I'm joined by Kristen Bosse, the Vice President of Product Development with CRIO and Samir Jain, the Vice President of product Management. Healthcare, data interoperability and EHR solutions with Medidata. And today we're here to talk and explore a recent development between these two organizations around an EHR to EDC integration and being able to, share that information a little bit more seamlessly. Really excited to discuss. This, it's been something the sites have really pinpointed as a pain point. But before we get into that, we'll start with introduction. So, Kristen, love to start with you and hear a little bit more about you and your background.

Kristen Bosse 0:53

thanks Jimmy. so hey everyone. I'm Kristen Bosse. The, as Jimmy said, the VP of product at CRIO. for those unfamiliar, CRIO is a clinical trial software platform built specifically for research sites, so it helps'em manage any, everything from eSource and scheduling to, to finance and billing. I've been with the company since 2016. so I started on the customer success side where I worked directly with sites to implement CRIO, and then I shifted to the, product side in 2021. And that's. Since then, I've been really focused on learning, taking what I learned rather on the CX side and continuing to improve the platform, including some of these interoperability opportunities, to tackle some of the biggest pain points site face, like transcription to EDC.

Jimmy Bechtel 1:32

Awesome. Thanks Kristen and Samir, please. Let's, let's hear a little bit more about you.

Samir Jain 1:36

my name is Samir Jain. I lead Interoperability Solutions here at Medidata. Medidata is a provider of, rave, that's our core platform, our EDC platform. a cool stat that I heard recently was that. 80% of all new drugs brought to market in 2025 were on our platform. so it's a huge, you know, scale that, that we, provide to, to sites and to sponsors. I've been with Medidata for about three and a half years. prior to Medidata, I really spent my entire professional career. Building and connecting EHR systems together. so, you know, when I joined I was really excited to help bridge the gap between clinical research and clinical care. which has traditionally operated somewhat in silos. And so, that's the opportunity that we have here. that's really what I'm passionate about and I've been, really thankful for the opportunity to do it here at Medidata.

Jimmy Bechtel 2:25

Well, thank you both and I'm, again, really excited to get into this topic and it's great to have both of you, um, here to talk about this. And, we know the collaboration, the, the project, the work that you all are doing together is really described as giving the power of EHR to EDC and how that data flows from one side to the other, to a wider. Array of sites. So what type of sites, Kristen, maybe, alluding to this benefit most from this type of work, and why have they been left out of this equation, or why hasn't this been a thing, I guess, for them up until now?

Kristen Bosse 2:59

I mean, when you think about where EHR to EDC integrations have traditionally lived, it, it's with your large academic medical centers, you know, hospital-based research programs, places that are already running on, some of these major EHRs like Epic or Cerner and, and that sort source of truth. So the, the patient data lives there in EHR and the integration pulls from there, but a significant portion of research sites operate, you know, outside of that world entirely. So you have dedicated research facilities, independent sites, or site networks, and they are not the primary care providers, right? Their entire focus is the clinical trial and the study data being captured for a specific protocol. So eSource was built for that workflow and it becomes a system of record that eSource does for a huge portion of sites that are running phase two and, and phase three trials. Despite that they've largely been left out of the EDC automation conversation, right? Because, A lot of it has been coming from a different data source, right? The, the automation that we've built so far. So that's the gap that we're aiming to close here, to try and extend that type of eSource, to EDC automation, to these different types of sites.

Jimmy Bechtel 4:04

That's, that's really interesting, Kristen. And, and because you're a hundred percent correct, the, different sites have different access to different systems. Some of them are not on EHRs, but they use, like you had, so Astutely mentioned the eSource as their primary, source of truth for the data. But, Samir, what is your perspective on this as well?

Samir Jain 4:21

You know, I mentioned that when I joined Medidata a few years ago, I came from kinda the, the healthcare, world, the health tech world. And one of the first conferences that I actually went to as a, an a Medidata employee was SCRS. And, as I started to talk to sites at SCRS, I realized that none of them use an EHR system. And that was, that was mind blowing to me. I had no idea, right, that, all of this. Research and cares being conducted and not necessarily captured within an EHR. and they were, you know, as I was talking what system are you using? And many of'em were saying CRIO. So I approached, Raymond at that conference and he was one of the first people that I met outside of Medidata in the industry. and he kindly explained, the different types of sites, to Kristen's point and the different technologies that are in use. And it made me realize that there was this massive. segment of the market that these traditional EHR to EDC solutions were largely ignoring. Right? And, in the time that we've, taken to build our EHR to EDC Solution, health Record Connect, we've seen really, really encouraging results, right? We reported last week, that and, you know, in one of our studies we were seeing 60% reductions, in query rates. 70% reductions in data change rates, just like massive impact. But it was locked to just. EHR based sites. And so we really wanted to build for everybody, and be able to, really make rave, the most user friendly data experience in the world when it comes to, to EDC. And we can't do that if we're largely ignoring a huge segment of, of, sites. And so that's really why we, went down this path.

Jimmy Bechtel 5:54

It's excellent and it really does sort of add to and compound on what Kristen had said, a around really speaking again to the point that you're all making, to all sites around really the core issue that we know exists. The reason we're doing this right, and we're talking about this, is to reduce. Not only duplicate data entry, but the risk associated with when one has to enter data into multiple places and, the errors and the deviations or the queries that, that arise from that. So a little bit of a, the two birds with one stone here, we're, we're solving something for the sites. we're also solving for, some of the challenges that we as a sponsor and CRO also face in this space and delays related to those things in data. Duplicate data entry. so when we look at that, let's pull on that right. With eSource to EDC integration, we know that it's been a goal for the industry for a long time. This is probably not news to definitely anyone on the call here, but most likely none of our users. We've seen this in the site landscape data, in a lot of anecdotal conversations we've had. This concept of integration and data flow from one system to the other, logically speaking, eSource to EDC seems kind of like the sort of the apex there, the top of the priority list. But Samir, maybe talk a little bit about what has historically made that connection so difficult for sites to achieve at any sort of scale.

Samir Jain 7:14

So, you know, there's a lot of research and literature out there about the impact of, you know, traditionally HR to EDC solutions. so that's, that's pretty undisputed at this point. The challenge has always been, how do you do this at scale? what is, what, what is necessary to be able to really leverage this across all of your sites, across all of your studies? and the, the challenge typically is that. The source is structured differently than the, you know, the EDC and, and so that traditionally requires a lot of mapping, a lot of upfront integration, effort training, you know, these are traditionally middleware solutions that, it's kind of like yet another solution that the user needs to learn. and so that's really, that was the way that we were trying to think of the problem statement a little bit differently. We wanted to tackle not just. Bringing the data over, but can we do it in a way that doesn't? Add to the burden of a site, right? how can we build this into their existing workflows, and really reduce the amount of upfront mapping and effort that's needed. And I think what sets, this kind of approach apart is that, we're not doing all this upfront mapping. We're actually presenting the data that the site has captured in their, eSource solution, we're presenting that within Rave and allowing them to pick and choose the data that they wanna bring over. and, you know, there's some intelligence on the, under the covers that helps them do that more effectively. But, but ultimately, the users in control, that was something that we heard loud and clear as we were developing the solution with sites. and that really helps us scale the solution extremely quickly.

Jimmy Bechtel 8:46

Very interesting. And, you know, Samir, current and, you know, future product, in operations and, and offerings and integrations aside. Right? Coming from the, the traditionally the EDC side of things, what Medidata is, proudly known for. but Kristen coming from the bread and butter of CRIO, the eSource side of things. Mm-hmm. Can you talk a little bit about that side and that perspective, and, from that, I, I guess from that user, approach as well.

Kristen Bosse 9:12

I definitely agree with everything Samir said, especially the mapping point. but I will add something from the eSource side that I think is equally important and sometimes overlooked, which is that eSource is, is purpose built for the site, right? It's designed around the protocol, the visit, the data being captured in, in real time with the patient and the way you structure the, the data capture platform. For a site coordinator to do their job in that way isn't the same as how an EDC wants to receive in store data, right? They're optimized for two completely different things. So historically, when people have tried to connect the two there, there's been this temptation to, to try and map them one to one. and that's where things break down because if you start building your eSource to accommodate what the EDC needs in order to make sure that they can. To map appropriately, then you risk, you know, compromising the very experience you design for the site, right. With the eSource platform. and its sites feel like the eSource workflow has gotten clunky or, or doesn't reflect how they actually work with the patient and then they're not going to wanna use it at the end of the day. There's always been this real tension, right, between serving the site well, serving the integration and, and trying to crack. That has been a big part of, of what makes this hard to do at scale. So the HRC integration tries to find a way to balance those two worlds, and, and preserve the needs of each.

Jimmy Bechtel 10:25

An excellent point that you really both astutely are making in the same sort of way. We've had this challenge of like, well, who do we speak to? Right? What language do we put this in? And I use that term language broadly. You know, when you talk about mapping and the technical language and side of things there and what that means Make it easy for the site and so it makes sense to them, but also then get the sponsors, the data and the information they need in the form that they need. It sounds like, really the apex of the challenge and I think it's great that we've worked on a path to solve that with the work that you're doing here, but also, a little bit of a look behind the curtain. For the sites who have been kind of scratching their heads. That might be listening, to why this hasn't been able to happen. So hopefully that gives them, some validation in assumptions or an understanding of why this has taken so long. But here we are working on this path. Kristen, I want to, I wanna go to you again and hear a little bit about when site staff are freed from this concept. There's this challenge of redundant or duplicative data entry. Where can we put that time and energy? W where does it go and what does that shift actually look like in practice? Again, coming from the perspective of an organization who developed these eSource solutions, so I'm sure you've seen, seen some of that transition directly.

Kristen Bosse 11:38

Honestly the answer is pretty simple, but I'll expand on it. when you take away the burden of, of reentering data that's already been captured, that that time goes back to the patient, right where we we're, we're supposed to be surrounding the patient. It's all about patient safety and, and site coordinators are some of the most important people in the clinical trial process. They're the ones, you know, building the relationships with the patients, making sure they feel comfortable answering their questions, keeping them engaged in the study. but when a significant chunk of their day is spent on manual data transcription, that's. Time and, and mental energy that, that isn't going towards any of that. So, you know, in, in practice what we hear from sites is that it's not just about the time saved, which they will see a huge time savings, hopefully. but it's also just about the cognitive load, right? That transcription is tedious, it's detail oriented work. You know, when, when you're doing a lot of it wears on you and, and it takes your attention away from the patient, right? So reducing that means staff can show up, more present for the things that, you know, actually require their. Human judgment and care and in a clinical trial setting that ultimately contributes to a better patient experience. Right. And then better data quality.

Jimmy Bechtel 12:42

Exactly. I couldn't have said it better myself, Kristen. It's, it's about. And I would also, you alluded to this, I would also, go to give merit to reducing burnout because like you had alluded to, when we talk about these redundant issues or these tasks that really do add burden or frustration or irritation, all, there's a lot, there's a lot of those. We all know this. There's a lot of those that happen at the site. So every little one, I would argue that this is a pretty big one. Every one that we can eliminate or reduce or navigate around, goes to provide what I would argue is higher employee satisfaction. So, kudos to you all for also tackling, maybe inadvertently another potential issue that we're facing as an industry we don't need to get into today. regardless is an important, I think, benefit to what we're doing here.

Samir Jain 13:28

So there's this concept in healthcare called practicing at the top of your license. And, it's really removing a lot of, the lower level work from highly skilled folks, right? And that leads to exactly what we're talking about here. Better job satisfaction, better outcomes for patients. You know, just a better, more efficient health system. And that's exactly what we're seeing here as well. Mm-hmm. And so it's freeing. It's not so much that people are doing less work, it's they're doing different work, more meaningful work, when you're able to provide these efficiencies for them.

Jimmy Bechtel 13:57

And Samir, I wanna, I wanna stick with you here for a second and then go to Kristen as well to get, your perspective on this. But for, as we conclude our conversation here, we can to close out what, for sites that are interested in taking advantage of the work that you have done, what does that path look like and what should they know going into, this new era of, reduced data? redundancy.

Samir Jain 14:23

So first off, if they're running CRIO today, and their trial is on rave, there's a really good chance that we can get this going for them. and so, you know, we'll, I think Kristen will, will likely talk about, kind of what the site needs to do to opt in. But once the site is opted in, we can work with the site to identify their trials, figure out which ones are already enabled, which ones. we've got a really easy path to enable for them. And, and then from there, it just works. Like there's, as we mentioned earlier, there's no mapping, there's no integration effort at the site level. training is a cinch honestly. and so, the functionality will just start showing up within their workflows and, it's about as easy as you can get.

Kristen Bosse 15:01

Yeah. And, and I'll add to that. So just from the CRIO side, very similarly, a minimal setup work required, right? So if the sites reach out to us, if they're interested, we will work with them to just, get permission from Medidata to access their. Their data within CRIO, but after that it's just working with Medidata to identify the trials. Um, and also just, just to reiterate, because we've already gotten some, some questions about this, I think what sites are, are most concerned about is okay, it's very easy to set up, but. As far as giving them access, but what do I need to do for my trials, right? How do, how do I make sure that this continues to work long term? And, and I'm gonna, um, quote Samir in a way where there, you know, it just works, right? Um, I, I'm gonna reiterate what I said earlier, that you don't need to change how you build your studies to make this work, right? That, that's something to definitely know going in. We're not asking you to design your eSource around the integration or, or worry about whether your data is really gonna be compatible just. build your studies the way you always have, the way it works best for your team and your workflow and, and let us handle the rest. So that was really important I think, to Samir and I going into this and how we approach this because the last thing we want is for the integration to add, you know, complexity on the site side or, or an extra burden. it should be a benefit. So just reach out and we can get connected, Samir and I, and get you going.

Jimmy Bechtel 16:11

That's great and I think an important point and a great one for us really to end is really this, this theme of the conversation here is, Really interesting and awesome directional integration that reduces burden at the site level. So it's great to hear that, you know, that is a continued focus as we look at, integration as well. So thank you both for your time today and for sharing, some of the insights around this. Again, really interesting integration. I'm looking forward to seeing what the future entails for this, and, and how we continue to. Bring this to scale and, I'm really interested to hear how it's received at the site level. I have a feeling it's going to be very well received, but, always interested to hear that positive reinforcement from the site. So thank you again for being here today and for sharing about this Kristen Samir, and your time.

Kristen Bosse 16:59

Absolutely. Thanks Jimmy.

Samir Jain 17:00

It's been fantastic working with the CRIO team and our sites Jimmy. So thank you for the opportunity here.

Jimmy Bechtel 17:06

For those that are listening, I hope you check out other great site focused resources made available to our entire community on our website, my scrs.org, including other podcasts, webcasts, and other technology related information and events. For now, thanks for tuning in for listening, and until next time.