PODCAST: How DCN Runs Better IVD Trials on Veeva

Emily Friedland: Welcome to Expert Insights from DCN Dx. I'm Emily Friedland, and today we're talking about something that sounds like technology plumbing, but matters a lot to anyone running an IVD study. Whether your study is running on a connected platform or a bunch of disconnected tools, I'm joined by three people who think about this every day. Jill, Thomas, would each of you introduce yourselves?

Jill Hutton-Pugh: Hi. My name is Jill Hutton-Pugh. I'm a clinical trial manager in clinical operations at DCN Dx. And I'm our clinical team lead on the connected platform here at our company.

Thomas Martinache: Hi. My name is Thomas Martinache. I'm the associate director of data management at DCN Dx, working mostly on the Veeva system and the Veeva integration that we've built — all this IVD build that we are doing at DCN Dx.

Emily: And we have a special guest today from Veeva. John, would you please give us your introduction and what your role is with Veeva?

John Acampado: Yeah, absolutely. Hi, everybody. Thanks for having me on. I'm John Acampado. I am part of our strategy team here at Veeva MedTech, which means, although it's a bit nebulous at times, it means that I'm ultimately responsible for making sure our customers, our partners, really have solutions that bring them value and can really expedite how they run their clinical studies. I've actually spent most of my time on the sponsor side of the house before moving to Veeva, so more often than not to the benefit of our customers. But then also maybe to the not so much benefit of my internal team here — I take the hat off, and I oftentimes think about how I would still expect things to be done if I were still a customer. Again, thanks for having me on.

Emily: Many of our listeners are at IVD companies trying to figure out who to trust with their clinical studies. So we're going to talk about why sponsors need to be thinking about connected platforms. Let's get into it. Thomas, before we get into the specifics of our connected system, tell me more about what it's like to run a study when you're stitching together separate systems — file shares, spreadsheets, one tool for clinical ops and another for data. What did that look like day to day?

Thomas: Well, for a lot of us, we are doing that every day. So that's kind of the normal way of doing things. Usually that means that most of your data, most of your information, are very siloed. You use one software, you export your data in one system, and then you analyze it on a different system, you run your edit checks. What that usually means is there is quite a bit of delay. There is quite a bit of lag between everything that's happening. It happens all the time where you run your data, you look at your data listings, you look at what queries should be made, and you hand that to someone else — and the data has already been changed by the site. So there is quite a bit of silo between all of the systems. There's quite a bit of handoff that needs to happen. On the technical aspect of things, you have to deal with multiple password permissions issues and writing. The things that I absolutely love — specifications to know: are you sending information, are you receiving information? What needs to be done, what the client wants, what type of report, and all of that. So all of those things kind of take some time to prepare, but also sometimes to run. And that's kind of the day to day for a lot of us.

Emily: From the clinical operations side, what did that disconnection cost you in time and in errors?

Jill: I would say the number one issue is efficiencies. That would be across clinical trial managers — all the trials we manage and the CRAs. We had disjointed, repeated communications that weren't captured in a centralized place. We also had a need, as Thomas and you have both referenced — we would log information on different platforms and in different formats, so we'd be tracking studies different ways. It also did not allow the trial managers an opportunity to get a strategic view of your study and the status of your study. In order to do that, you would have to have team cooperation and logins to the spreadsheets and daily updates and things like that, which were not at all efficient. They took a lot of time out of everyone's day. If you could get people to even keep them updated, and that really cuts down on the quality of information you can give your sponsor when they have spontaneous questions. We don't want to delay when we're answering them, and we could spend a lot of time collecting that information, or we could have it at our hands and look a little more professional and be able to respond to them more quickly. I would say in terms of quality, it was difficult to ensure the quality of some of the documents we would hand over without a complete manual review of, for instance, every eTMF document from all of the CRAs — and that type of thing. So very difficult to control. Very difficult to have consistency.

Emily: What I'm hearing from Thomas and Jill is that these disjointed systems require a lot more resource planning and still result in a lot of potential errors or problems across projects or within a project. John, you see this across a lot of organizations. Is this model, this patchwork model, the default for most CROs and sponsors? And why do you think that exists still?

John: I think it's going to be a bit of a mixed bag. It's going to be different for CROs, different for sponsors. And I've seen this change quite a bit in my time in the industry. When I first started out, folks were really just looking for a "let me figure out what the best solution is out there" without really thinking about how everything is supposed to work together. But now, as obviously budgets have probably shrunk and timelines have continued to accelerate, we're being asked to do the proverbial more with less, or more with the same. When I was at the sponsors I was working with — for both the medical device, diagnostics, and pharma — there has been an increasing trend over the past several years to try to unify those systems. Everything that we do from an operational perspective is actually connected. So the data that is collected at the site has a downstream impact on what needs to be monitored, what needs to be studied, how that information needs to make its way into the monitoring report that we were alluding to, how we can eventually get all that documentation filed appropriately into the master file. So from my time at sponsors, there is a decreased need — a drive to move away from that patchwork process and those various systems. Way too much time had been spent by me and my team in terms of context switching. However, for CROs, there is still a bit of that mindset of, well, we can kind of just make it work. For those that have a very clear vision on how to run the clinical studies and grasp the idea about trying to be as efficient and really do take that approach to unify themselves, others who have worked with both on this side as Veeva and from my time as a sponsor take a different approach. But the results of taking that different approach — if things aren't fully unified, it's everything that both Thomas and Jill just mentioned. It can lead to delays. It can lead to quality gaps. It can lead to documentation issues. So obviously I am a bit biased, but there's nothing like a little confirmation bias in the afternoon. So I'm a fan of trying to make sure that things can be as unified as much as possible.

Emily: Since you came from the sponsor side before Veeva, and you now sit on an MDIC working group, you've seen all of this. John, when you were the one that was selecting CROs and managing them, what did the systems that are disconnected like this feel like from your seat as the sponsor? And what did you wish your partners were doing differently?

John: To be quite honest, back when I was not in the system I'm in now, but when I was selecting and partnering with different CROs, I wish more folks definitely took an approach to what we all are doing here at DCN Dx, and having that full visibility — and knowing that anytime I ask my partner, hey, what's going on with this study? Or where are we with this deliverable? Having that real-time touch to how the studies are being conducted, it's irreplaceable. So I do think that there is a lot to be gained from that. And touching on that — the MDIC working group specifically focuses on IVD standards. And a big part of standardization is not just how the data is collected, but also just the systems that are being used. So obviously I'm a big advocate for that in terms of how we unify not just the solution, but also how we collect the data as well.

Emily: We've talked a bit about the disjointed systems that other organizations have, and that DCN Dx has integrated platforms through Veeva. Thomas, walk us through how we developed this at DCN Dx. We started with the electronic eTMF in 2022, then we added EDC, and then CTMS in 2024. Walk us through how we made the decisions of implementation in that order, and what did each addition make possible for us as an organization?

Thomas: Sure. So the choice was mostly led by the needs — from what we needed to have as a system at the time. And that's kind of what led to that order: the eTMF first, then the EDC, then the CTMS. When we started with Veeva, because of that approach, you don't have to have everything set up right away. We were not ready in 2022 for a full, complete system that had everything, because we didn't have the need for that. Of course, the studies were fairly small. We barely had a need for quite a bit of systems. So we needed definitely a eTMF to be able to collect all the documents, to make sure that we had someplace to store all the files. Then we grew with the business growth. We had clients with more needs. We definitely could see that we were approached with the requirement to collect data on a system that's not Excel. A lot of our small clients tend to collect data on Excel or things like that. And so we figured that in order to still keep the timelines — that IVD deals with very short timelines — we thought we needed more control on the EDC, and so that's why we went through the enablement to allow us to build the EDC ourselves, instead of relying on outsourcing and working with other specifications, other documents, and all of that on their own timeline. After a couple of years — basically after two years — we were confident with the EDC. And so that's when we found the capability to build quickly, to build efficiently. And that's why we figured that in order to bring more quality to the clients, we brought the CTMS in. We added the CTMS. And so that's what allowed us to have, as Jill said, a lot more context in the reports, a lot more visibility on what's missing in terms of documentation, in terms of things, and making sure that we always use the latest version of each document to have better visibility for all the CRAs for their monitoring visits. A lot more information is flowing from the EDC directly into the monitoring visit, without having to re-enter the data somewhere else. So the integration of the CTMS was mostly in order to get better use of what the system already had, and to allow the client, the sponsor, to see everything that's happening — to be able to see their data, how it's progressing, all the sites are working, and everything that's happening for them.

Emily: Jill, you led the team through this change and know the Veeva platform inside and out. What changed for your team once these systems were talking to each other?

Jill: I would say again the biggest piece is that integration and efficiencies and stability for strategic view. I think that Veeva allowed us to kind of move from running a study and showing how — moving through the steps that a clinical study requires and guiding our sponsors through those — to actually managing the study. It gives you the tools you need to manage the study. You can look daily at enrollment easily. You can look at enrollment against targets for protocol limits. You can run reports really easily on different site efficiencies. You know, let's say time from site activation to first enrollment, time from first enrollment to COV. And you can trend enrollment. You just have so many tools at your disposal to truly manage the study. And for CRAs, it allows them to manage their sites more efficiently. They can look at their enrollment. With the linkage to EDC, their SDV data is integrated into their monitoring reports. Their PDFs can be integrated into their monitoring reports. It allows us to track the traceability through monitoring reports of issues and follow-up items. It just can't be beat from a regulatory perspective. And that's not the kind of thing we could do without an integrated system. We don't have the time for that. And it's a critical piece of clinical trial management.

Thomas: I mean, can I just add a small thing? So one of the biggest benefits of a connected system, I think, is also that you don't break everything every time there is a change. We all know that there is always a change in the study. We all know that there is always an amendment, and making a change in the EDC will not break the system. Or at least the system will tell you when it's not possible to do that this way and it needs to be done differently. And so instead of making the change and realizing the week after that the connection doesn't work and you needed one more week to fix it — now you can see that the data continues to flow even when real life of the study happens.

Emily: That's great. It sounds like it enables the ops team and the data team to really work in a continuous partnership throughout the project. John, when a CRO decides to put data management and clinical operations on one platform, what are they really signing up for, and what surprises people about that decision?

John: Yeah, disconnected systems and those silos that both Thomas and Jill were talking about really can cause a lack of trust in data quality. So standardizing on a platform really provides much better visibility and gets to that proverbial — I'm using air quotes here — "single source of truth." As you have manual processes, whether it be at a CRO or a sponsor, that's incredibly inefficient and really not scalable. So as you think about everything that Jill was talking about: no integration delays, no delays in your timelines, much better visibility. I often think about the quote — and I again am taking the Veeva hat off for a second — the biggest lie that we can be told is "it's not that easy." Quite simply, it is. You know, sometimes you've got to just put the systems together and let the teams do what they need to do. What they're really signing up for — and what surprised me — is the amount of time that my teams got back previously. So they weren't spending time chasing down this site or that site. It also allows the sites, right? If you think about the relationship that sponsors and CROs need to have with the sites and ultimately the patients that we are really trying to provide a service to — that allows us to give more time back to the sites, because then they're spending less time in the systems. So if you think about site engagement and helping the sponsors that you work with from a DCN Dx perspective, get to that sponsor of choice for those sites — it's not just about the systems and the integrations. Yes, that's a big part of it. But the most surprising part of it for me, as I have spoken with sponsors, CROs, sites and patients, is that this has actually given them a lot of time back. Not just from a "can I get my product to market faster?" — yes, absolutely. But just in terms of the quality of life for the sites that we're working with. That's probably what surprises folks the most, because there's actually some meat on that bone.

Emily: Great. And then drilling down a little bit more on your perspective from the Veeva side specifically — was it selfish for us because we are an IVD-focused CRO? Why does the IVD industry need its own approach? And what are you hearing from companies that pushed Veeva in that direction?

John: Yeah, it's a really fantastic way to distinguish the difference between what we do in just MedTech versus pharma. And then if we go a little deeper, what the difference is between pure play medical devices and then in vitro diagnostics. As part of that MDIC standards working group I was a part of — and am a part of currently — there was some research that was conducted that showed that IVD represented about 66 to 68% of all decision making in the life sciences space right now. And so having that dedicated focus about why things are different, and being able to acknowledge that, is important. And so the IVD industry as a whole — we aren't necessarily — I mean, maybe if we're doing a companion diagnostic study, maybe we are collecting the same type of information as a large-scale oncology or pharma study. But by and large, it would be beneficial for us to have our own templates, our own ways of doing things. Even in the discussions I've had with you, Thomas, ideas that need to be launched for IVD are very different than the studies that I ran previously in oncology or nephrology. Sometimes for IVD, the team is chasing a disease around hemispheres, right? And making sure that we have the appropriate samples for IVD. Another example that I can think of is we can't have a system that will take us seven, eight, maybe nine weeks to do an amendment when our study may only run for three months or four months. So really having that ability to be agile — and actually having that follow-through from the systems and from the people that you're working with as well, like your teams, the sites — understanding that this is different than how pharma trials are run is just absolutely vital to how those studies can actually be successful.

Emily: I totally agree. We had a conversation with another part of the Veeva team earlier this morning, and we were discussing our current implementation and future implementations. And I have to always commend the Veeva team because we came to you with not just "we are a CRO," which is a challenge for systems in general, because our studies come in and out of the systems more frequently, and the volume of studies often is significantly larger and more frequent than a sponsor organization. But then on top of it, we've layered in the challenge of in vitro diagnostics, which we're always trying to kind of shoehorn ourselves into existing systems — whether they're regulatory frameworks or electronic systems that kind of are built for us, but are meant more intentionally for a broader medical device audience most frequently. And so I commend the Veeva team for really trying to meet our very, very specific, layered, difficult need. So let's get into the part sponsors care about most. Thomas, when a study runs on one connected platform instead of a patchwork, what does the sponsor see on their end?

Thomas: They see a bigger picture. At least they see a lot more information than what they usually have by going into two or three different systems. The fact that you don't have to go to a different system to know how many subjects were enrolled, or that the query has been sent — all of that helps them to have a better picture, a better idea of what's happening, and ultimately trusting us with the trial. There's definitely a gaining of consistency of the process. You don't run into — as we say, we don't run into the problem of multiple versions of the reports. And so on. But there is a lot more scrutiny that comes with that. We usually have a lot more questions, a lot more specific questions from the clients regarding some specific data, but they also realize that having a system that's connected allows you to not have a missed email in an inbox. They can really look at everything that's available, so that's kind of a double-edged sword. We usually see that our clients are a lot more involved in the study — a lot more involved in things, a lot more questions — in a good way. It really allows them to see a trend, to see what's happening, to trust us, and to bring interesting questions and interesting evolution of the trial sometimes. So it can be a double-edged sword, but in a very good way. I think it's a very important way to get a better trial, ultimately.

Emily: Jill, one thing that stood out in the presentation that you and Thomas prepared for the Veeva MedTech Summit recently was visibility — real-time enrollment and milestone reporting. Why does that matter so much to a sponsor?

Jill: I think particularly — again for IVD studies — these studies are very fast-paced and they can span a very short period of time. You can enroll 40 patients a day, and that's atypical, I think, of other studies. What this allows us to do is have a real-time enrollment picture. It allows us to have immediate answers to questions about enrollment. We can help partner with the sponsor almost as a business partner, because every month they run a trial is another month's worth of expenses for them. As we look through the sites' enrollments, we can track how they're doing very easily. There have been instances where we can ask a site to enroll more because they're enrolling very well. There are other sites where we say maybe we won't be enrolling there anymore because their enrollment is slow. It gives us real-time data to partner with them, to help them run the studies as efficiently as possible, and potentially run a study over a shorter period of time and help them meet their enrollment goals sooner.

Emily: Thomas, you've talked about reusing roughly 60% of the work from one study to the next instead of starting from scratch. What carries over and how does that affect the sponsor's timeline and budget?

Thomas: Sure. So at least for the EDC part, there's a lot of forms that can be copied. For example, the adverse event form, the protocol deviation, the demographics — these are often very similar across IVD studies. They are not exactly the same, but they're very similar. And all of that can be copied with just a click of a button. There's always modification that needs to be done, but it's already a significant gain on that. So we started to have kind of template paper CRFs that are there. But a very big, significant gain for us was also — once you start to have a library of edit checks, there is more and more of those verifications that we have in the system that we can reuse and modify as needed, but they don't need to be rebuilt from scratch. So that's quite a bit of gain for us on the sponsor side. Usually that means that the EDC, instead of being something that's being talked about during the study meetings for three to four weeks, they can start to see the first CRF — the first electronic version of the CRF — the week after. All this on week two, and then suddenly you get the first questions. They start to be able to see it, they start to make sense, they start to enter data and they have questions, and then the CRF changes. But ultimately the goal is to have better data, to have better information, a system to have something that will happen in real life. So for the client timeline, that's a lot more visibility all year. For the client budget — if we're not going to spend six weeks, eight weeks to build a system, it's a lot faster timeline. And every month is important for every client. Every month is important.

John: So if I can jump in as well, Thomas — just to highlight everything that you mentioned, the standards are one thing, but there's also something we call a difference report. It's a fully validated report within the system that actually highlights what has changed from point A to point B within the study. So it not only accelerates what Thomas and team are doing — they're not only able to accelerate how much time it takes to build the study, but it also accelerates how much time it takes to test the study. Because then from a CRO and sponsor perspective, you can quickly see what has or hasn't changed, and then you're not really spending time retesting anything that's already been validated. I know in previous discussions with Thomas, you all are really working hard to get the study timelines down well beyond the typical study timelines for most study builds. We have some other sponsors that are getting there — they're really pushing. Can they get to a one-week build? Can they get to a two-week build? That's always been something that I've wanted to get to from my time as a program manager. And I do think that the things that you and your team, Thomas, are working on are definitely getting closer to that.

Emily: But I do think that sponsors often have programs where study after study are very similar, because they're developing products that are similar to each other or next generations, or have multiple studies for the same product — either in different regions, or with a slightly different intended use or intended use population. And so that's a good evidence of the ability to get to that one-week timeline that I suggested sponsors are trying to get to. John, going back to these sponsors — a lot of small sponsors, and I can tell you I get this feedback too, when we say that we use Veeva. They assume a platform like Veeva is only for Big Pharma. What do you say to an emerging or even a middle-market IVD or MedTech company that thinks they're too small for Veeva?

John: It's a really fair question to ask, because even before my time here at Veeva, I was at Becton Dickinson — so large, at least at the time, medical device and diagnostics manufacturer. So I can safely say it isn't just for Big Pharma. In fact, a lot of the customers that we're working with right now are some of the smallest companies that I've ever had the opportunity to work with, and we've helped them take their product from ideation to commercialization all the way through and help get their product approved. I think the idea that Veeva is just for Big Pharma can definitely be dispelled by having the appropriate conversations with other folks that are also using the solution. Within my team specifically, Veeva has a dedicated MedTech organization that lives in device and diagnostics. I don't wake up and put the MedTech shirt on, and then the next day put the biopharma shirt on. I just have one shirt, for better or worse — and it's the MedTech shirt. So we have both MedTech and IVD-specific templates for our eTMF. And I think Thomas can attest to some very strong recommendations about how to design, or maybe not design, specific studies. Now again, taking the Veeva hat off — are there certain things that we could do a bit better? Absolutely. But one of my requests when I first joined Veeva is I want to have a direct hand on the steering wheel, so to speak, on how the product is going to be designed so it can be reflective of what we need in the market. Having that trust with my product team, with our services delivery team, so that they have an understanding of not just what we need from a product delivery standpoint, but then also they have a clear understanding of the price tolerance — because that is a very big difference as well from pharma to MedTech. Having that built-in MedTech expertise, I think definitely is a testament to Veeva's dedication and acknowledgement of how different it is with what we do within device diagnostics, and more specifically, within diagnostics compared to biopharma.

Emily: I do have to say that I don't ever feel like I need to translate to the Veeva team the language of diagnostics, which with other partners I've worked with — whether when I was on the sponsor side, they were CROs or they were service providers like Veeva — I often had to step in from the sponsor side and manage portions of work that I should have been able to outsource, simply because the language wasn't there for me to properly communicate what I needed from those partner organizations. And we definitely don't find that with Veeva. I will say the other story here is that we were a small business when we started with Veeva, and our selection process was: what is the best solution? Not what is the cheapest solution that will get us through to the next solution. That's not saying that Veeva is incredibly costly, but if people are looking at very inexpensive solutions because they're trying to meet a need immediately, the cost of changing to a solution that is more robust — when you have the cash to do that — may not actually work out in your favor financially in the long run, or from a timeline perspective. And so I think going with the best platform that understands you from the beginning is always the best approach.

John: Yeah, absolutely. If I can just add one thing — I know that we've known each other for a little while, Emily. So I think one of the things that Veeva has definitely prided itself on, especially for me coming over from a customer perspective, is that we've always liked to say we want to move at the speed of trust. That goes both ways. We want to make sure that people are comfortable with our solutions, yes, but then more importantly, that they're going to be comfortable with the recommendations that we can make. Going back to the original question, the difference is stark between the data points that we may collect in pharma versus the data points that are collected in a cardiovascular study, versus data points that have been collected in an assay study. And having that clear differentiation — and knowing that just like you trust Thomas and Jill to make the appropriate decisions for your teams — I think that goes a long way.

Emily: Jill, DCN Dx specializes in IVD studies that need resources deployed fast. How does this connected platform help us move more quickly?

Jill: Again, it comes back to efficiencies. We can't say it enough times, and we don't have enough time in this hour for me to list all of the efficiencies that it has brought to us. But the truth is, we have all of our information now captured in one place. We have historical information about study sites. It's important to have study sites you know are productive and have the right population — and grasp those study sites quickly. We have that information. We have information on which CRAs are available and how many studies each CRA is currently working, and how many study sites they're working, so we can plan for resourcing that way. We have historical information on whether a site has qualified previously, so we can potentially not have to spend the time and energy qualifying that site and move more quickly. There are so many factors — almost everything you can imagine connected to a clinical trial — that we can now, through the customization features the Veeva team has worked on with us, have some semblance of that data captured all within the system. And deploy whatever we need to deploy, run whatever reports we need to run to determine which CRAs, which reference laboratories, which study sites, which areas of the country are going to be able to get this study up and running as quickly as possible for the client.

Emily: And Thomas, how has the platform taken the busy work off your plate so the team can spend its time on the study itself rather than administration?

Thomas: There's definitely a lot more standardization in the data from using one system instead of multiple systems. As we said, you don't run into the issue of using the previous version of the monitoring report. If you have something that needs to be modified, you can do that directly in the system. You can send it back. You don't have to keep track of all these changes — the system is doing that. So you don't have to save multiple versions of the report somewhere. All the history is already in the system. After when you configure, there's also a lot of safeguards you can put in place. You can only allow the system to go forward past a certain point if you have all the mandatory documents, etcetera. If you have edit checks that you create in the EDC, all of that ultimately removes some of the need to manually look to see if something is missing. Because the most difficult part of a trial — you'd always have one document that's missing. The system really shows you what's there, what's not there, what's expected in terms of documentation on the CTMS, but also in terms of data in the EDC. That gives you a lot more control, a lot more time to think about what you can do better for the next trial, what you can do better for the current ones.

Emily: Automated data population and fewer manual handoffs — how does that change data quality and what a sponsor can trust when the study closes out?

Thomas: It improves data quality for sure, because you don't run the report on last week's data, or you don't use the wrong data. The system is doing that automatically for you. You always have the latest information. So for query management, you don't write a query on the data that's already been corrected by the sites. That kind of avoids the problem of a query that's been asked for when it's already been resolved — the system already sees that there are changes and that the query is no longer relevant, and will automatically close it. We've seen that we're able to give a more accurate picture of the trial during our weekly meetings with the clients. But ultimately it makes the life of a statistician a lot easier — to always see the same forms, the same variable name. She's going to be able to provide the reports, provide the statistical analysis, a lot faster. A trial manager is able to look at the data live and not at an export from two days ago or three days ago. As Jill mentioned, most of our trials have 30 subjects per day per site. So if you look from two days ago, suddenly you're missing 150 subjects — and that's a pretty big deal for our clients.

Jill: So for a sponsor heading into an audit or an inspection, what does it mean to sit on a compliant, connected foundation instead of explaining a tangle of separate systems?

Jill: Well, probably everyone on this call has been part of an audit before, and they are harrowing experiences. And I've watched smaller companies deploy everyone in the office — even people who are manufacturing the device itself. Everyone's running in, grabbing files and at the ready. That is not a way you want to run an audit. Obviously, you want to be completely confident in the documentation you have and the order of operations. Everything you've done is compliant. And I believe Veeva actually started as a regulatory-based system. And it's clear from the eTMF that that's true. The eTMF is tied to different stages of the study. So everything is calibrated that way. Like I said, even just on monitoring reports — the ability to see follow-through on issues from monitoring report to monitoring report. Was that issue resolved? Was it not resolved? The fact that when you're filing documents, you can put expiration dates for CVs and GCPs. So you know immediately if that GCP is no longer valid. Just knowing that the eTMF is complete, knowing that the documents you've collected are documents that are absolutely required, to have an inspection-ready eTMF — the traceability of the monitoring reports, as I said, and just the sequencing of the study — it's very easy to run reports and understand that you did everything in the proper order. Your SVSs preceded your SVSs, preceded activation. You're not sorting through emails and different things to kind of tie together evidence of timelines. It's all in one system for you.

Thomas: And to add on that also — one of the great things about using a connected platform like Veeva is that we also have access to the validation they've done on the platform. You don't have to deal with the technical validation, making sure that the systems talk to each other. All of that is already available on the platform, so that's a lot less management of the system. For the data management part, all the systems talk to each other, are validated, and you can rely on the validation from Veeva.

Emily: And also those certificates are easy to find on the Veeva website — should you need them within five minutes for an inspection or an audit.

Thomas: Not that it ever happened. EMILY Exactly.

Emily: Thomas, what are you working on next? Actually, I'll open this up to Jill and Thomas. What are we working on next with Veeva? And where do we go from here?

Jill: I would say on the CTMS side, our next big project is customizing dashboards and reports. And this is a testament to the Veeva team — it's not as easy as it sounds for an IVD study, and they have worked with us for months trying to adapt the system as needed for our specific needs. And our needs may be different than another IVD CRO. But they've been very patient with us and helped us work on that. The more we're able to create those types of dashboards, I think the more all of our staff will become more dependent on Veeva for managing the study, which I think is very important. If people can log in in the morning and just look at the state of their study in one or two dashboards and know what their actions are today or this week — and understand what needs attention versus waiting for issues to pop up — it just increases our professionalism and our look to our clients. It just allows for, again, a level of study management that's high-level strategic study management versus just doing the tasks that are expected to run a study.

Thomas: I think a lot of the things that we're going to work on next are going to be related to the quality of the trainings. That's kind of what we're talking about right now — using the system to track better, to have a better view of the trainings of the users, of the sites. And then ultimately, as Jill says, there's going to be a lot of reporting — but working to standardize all data even more on the statistical part. That's going to be a big part of my time for the next couple of weeks and months.

Emily: One of the things that we saw at Veeva MedTech — the conference — and what I've seen continually with the events, is really understanding users' needs and the gaps that need to be filled. As Thomas was mentioning, a product that I'm really excited about — and that Jill and I were looking at this morning — is the site training module. Which would automate training, follow-up documentation, connect to your eTMF, and really be able to properly document training on both the sponsor or CRO side and the site side, and be able to implement updates to documents that need to be trained on — and things like that — in a very timely manner. I'm really excited about that. And also potentially using Site Connect, which allows sites to kind of directly provide documents to us in a Veeva platform, and would unburden us from having to pester sites about getting documents. That also gives us a better real-time view into documentation that we might not collect as frequently, because we do it in our less frequent monitoring visits. All of those things I think are really exciting, and things that DCN Dx will be looking at implementing in the near term with Veeva. Jill or John — for someone listening who must make these decisions for their own program, what's one thing that you'd want them to walk away with?

Jill: To me, the most important thing that I can say is that I didn't even understand the ways that Veeva could help us, or I hadn't really integrated it into our own business thinking immediately. It was when we started working with the Veeva team that we were able to develop new ideas and new approaches and new ways to use it to cater to our business needs — and that Veeva has helped us develop those. The Veeva team has taken the time to customize a lot of areas for us so that we can use the system in unique ways to manage our business. And that to me — again — is something you don't always get with larger companies. This is not an out-of-the-box solution. This is: here's where we start, and if you're willing to work with us, we can get you to here. And let's find that together. And they've put in a lot of hours and a lot of work for us — customizing almost every single piece of the CTMS side for our type of business.

Emily: John, looking out over the next few years, where are clinical operations and data management headed for IVD, and what should sponsors be getting ready for now?

John: Always thinking about a little bit of a gap from what our cousins or colleagues are doing on the biopharma side compared to what we're doing here in MedTech. I'm sure everyone is inundated with AI and all of that, right? I do think that especially for what we do in device and diagnostics — and especially around IVD — getting ready for that is especially important. So having that foundation of a unified platform, unified data, is incredibly, incredibly vital. Just like how we don't build skyscrapers on quicksand, we also shouldn't have AI standing on top of non-unified data and solutions. So as we think about the proverbial ask from our leadership — not just me here at Veeva, but I'm sure you three are getting it every single day — like, how can we do more with less? Or how can we take on these studies but you can't have more headcount? Emily, these are questions that I'm sure every organization is dealing with on a regular basis. Quick anecdote — growing up in the 1900s, my bar for AI is very high. I'm thinking about Terminator, I'm thinking about The Matrix. We're not there yet. And so I do think making sure that from a sponsor perspective, that we are taking a pragmatic approach — or trying to get to the point where we are moving away from that very deterministic view of AI — those are all the things that we need to start to get ready for. And ask our own organizations: hey, we can do this better now, but what is it you want me to be doing in five years? In ten years? And in fifteen years? That's always what I'm asking myself. And making sure that I can pressure-test with my own team here at Veeva — that it's not just about the studies we're doing now. It's the studies a decade from now that we're going to be asked to take on. So very long-winded way of saying probably AI.

Emily: I think that's the answer to a lot of questions these days. It's probably AI. Thomas, Jill, and John, thank you all for walking through this. Thomas and Jill are co-presenting a webinar with Veeva — Platform Over Patchwork: How Consolidation Drives IVD CRO Efficiency — on Wednesday, July 15th, from 8 to 8:45 a.m. Pacific, 11 to 11:45 a.m. Eastern. It's free, and you can register through Veeva. There's a link in the show notes. They'll go deeper into everything we talked about today. If you want to talk through your own program, you can reach out to us at DCNDx.com/contact. Thanks for listening to Expert Insights.