Webinar: Tech-Enabled Trials from eSource to Centralized Monitoring and Modern Patient Experiences

Simon Burns: Thank you, everyone, for joining us today. I wanna kick off by introducing our panelists. Today’s webinar is on tech-enabled trials from eSource to centralized monitoring, and modern patient experiences, and we have a great team of panelists here to to speak to those topics. First, my name is Simon. I’m the co-founder and CEO of Vial. Vial is a next generation CRO that was built to reimagine clinical trials and power faster, more efficient trials for sponsors.

Betsey Zbyszynski: Hi, everybody. Thanks for joining us. I’m Betsey Zbyszynski. I head the dermatology division here at Vial, so I oversee our dermatology studies and help provide strategic guidance. I’ve been in clinical research industry over 25 years. I played many different roles. I started out as a coordinator, I was a monitor, project managed, and most recently on the CRO side, playing leadership roles in operations and strategy.

Simon Burns: Thanks, Betsey. And now Karina and Dhruba.

Karina Garcia: Hi, I’m Karina. I’m the site director and DermResearch. I have over 10 years of clinical research experience at the site level, and I’m very excited to be here today with you all.

Dhruba Biswas: Hey, everyone. I’m Dhruba. I’m one of the clinical project managers. My background is in hematology/oncology primarily working on immunotherapy and CAR-T trials, and I’m excited to be here.

Simon Burns: Thank you, all. So let’s jump in with a quick background on, Vial. Vial was founded to execute on a mission to reimagine clinical trials, and make them faster and more efficient for sponsors, and we do that in really two main ways. The first is, we built a site network in every one of the therapeutic areas that we operate in, and that site network means we get really close with the leading PIs. We integrate closely with their systems to enable what comes next, which is our, technology platform. And by building a technology platform that operates from end to end from first touchpoint with the site as part of a trial, through to the, CSR being submitted we’re able to drive a much more efficient trial.

But before we talk about what Vial has done, we’d love to set the scene with the challenges that we’ve set up to face. It was only through a process working very closely with site sponsors and other folks to be able to understand the challenges, that we got to where we are today. But let’s take a first principles approach here, and talk about the challenges. I think, as we all know, clinical trials are slow and burdensome for both the site, the patients, and the sponsors, and, in particular, they’re quite burdensome in the site startup process. And let’s kick off the conversation with the panelists here.

Let’s talk about site startup. It’s, quite challenging for really all, sides of the equation but Betsey, kick us off. What are the challenges in site startup from the, CRO perspective?

Betsey Zbyszynski: Yeah, startup has always been the most challenging. The front end. Getting all sites up and running at the same time, getting enrollment started to meet that FPI date. Sites are on their own schedule, someone may be on vacation, you might not be able to get a signature page, you might not be able to get this document back, negotiating contracts. There’s so many moving parts, and each site has different processes, so there is usually a lot of team members from the CRO involved trying to make the timelines as best they can. It’s always been a challenge.

Simon Burns: And, Dhruba, Karina, you Come from the site side, but now see, both sides. Maybe, to kick it off next Dhruba, tell us more about the challenges that you see on, site startup.

Dhruba Biswas: To piggyback off of Betsey, a lot of that communication is just done via email, and attaching large attachments, and then sending it off to a third party that needs to review the documents, and then reviewing that, and appro- approval notices. There is a lot of back and forth communication that just happens over email and PDF attachments, and just by the nature of email and people being out and everyone being busy, there is a clear roadblock there that impedes the rate at which a sponsor can select trials and start up sites to be ready for enrollment. And there’s a lot of room for improvement in terms of actually just automating these, quite minute and mundane tasks.

Simon Burns: Before we go to Karina, you were previously running. many parts of these processes before. What’s the longest it took you to onboard onto a trial on the site side?

Dhruba Biswas: The longest it’s taken me to open up [00:05:00] a study has been 12 months, based on negotiating the budgets and just making sure we have all of the site equipment because of recent delays in shipping. [laughs]

Simon Burns: That’s crazy. And, Karina.

Karina Garcia: Yeah, I absolutely agree with them. With site startup we tend to get bogged down with what seems to be a lack of organization on the CRO side. For example, we typically, during the pre site-qualification visit, have answered what seems like a million different questions, have sent in all these documents, but then post site-selection, we typically get a lot of delays as we get passed on to two or three new contacts. And then those new CRO contacts ultimately end up asking us to redo a lot of the work, because they don’t have access to the previous information we’ve submitted.

If there was a way we could really rely on clear set of steps for our site to go… Maybe a, like you said a, portal, really, to break down what exactly is needed on our end, that would be amazing, because, for now, CRAs come and go and we’re really left in the dark for a large part of the site startup.

Simon Burns: And we’re talking about site startup like it’s one large process, but there’s many sub-processes within it. There’s feasibility, there’s the [inaudible 00:07:38] packet collection, there’s contracting for the CTA, there’s of course budget negotiations. Maybe unpack the, challenge that is site startup. Which of those is the most painful? And let’s reverse order, we’ll start with Karina and, Betsey.

Karina Garcia: Sure I, think that contracts and budgets just take such a long time where it really affects our site and our enrollment, because we may have anticipated we’re ready to go with this study ideally in two to three months, but if there’s delays and they’re going back and forth between their own internal departments, all of a sudden we’re six months down the road. We still haven’t started, we have PIs out of the office, or we’re hitting holidays, and it’s just ultimately gonna end up suffering both the enrollment and the staff workload. I- it’s a pretty big delay, and I’d say that, that’s probably the largest pain in in it all, is the contracts and budget.

Betsey Zbyszynski: Yeah, totally agree. Most sites don’t wanna start any activities even… Some sites don’t even really wanna sign anything before they see the contract and agree on a budget, so we try to start getting that done as soon as possible, but that is definitely the most challenging and requires the most attention.

Dhruba Biswas: Yeah, and I’d say even one step back, when we’re actually choosing which sites that we wanna work with as a sponsor or a CRO making sure that we choose sites that are actually gonna be able to produce for study is really important. A lot of sites, they have competing trials they don’t have the capability or the site, they don’t have the right resources or labs in order to process for the study. Actually having some sort of database or, at least, large data on which sites would actually be a good fit for which trials, is really, important.

Oftentimes big companies wanna work with big institutions, but that kind of negates a large population of patients that could potentially be good enrollers onto these trials. Having those metrics is I think, something that doesn’t really exist right now to that great of an extent, but it would be really, helpful in terms of determining what sites are feasible to enroll.

Simon Burns: Awesome, thank you. Site startup has been a key focus for us at Vial. We hold ourselves to this high bar, which is greater than 90% of our sites are onboarded into a trial in under 30 days. And how do we do that? Exactly like the panelists described. Today, site startup is, a story CRA’s going back and forth, emails, PDFs, lack of status awareness where, things are at any given point in time. Response times take a long time. 

More than that, the systems don’t really enable a smooth process. You’re, tracking something in Excel, tracking it… I’ve gone back and forth myself going through, through notes in, an Excel. You’re on the fifth or sixth note, the note gets dropped, you lose track of where the negotiations were. This is not how you should be running the site startup.

The way we run the startup at Vial is, one platform, one web interface, one status for all the steps that are part of the process. It really is a move from PDFs and email to a seamless web-based process and, coming from a technology background and merging it with a team of phenomenal leaders we’ve been able to build this platform. Working closely with sites and our CRO team to understand the needs, build a platform. And it’s everything from online feasibility… Most if the information is already filled in, but what isn’t filled in is easy to add on behalf of the site.

Automated online budgets. This means going through the process, really clear process of, adding in per procedure [00:10:00] bids, going back and forth getting to final approval, and online legal and contracting process. No more going back and forth with redlines, PDFs, not knowing to track track changes in in a CTA. Now, a web-based platform enables a much more seamless process.

Let’s jump to our second question for the panelists, which is the pain points in creating source capturing visit data, and dealing with queries. Let’s, start again with, Betsey, and this is a whole world of challenge in, running a trial. We’d love to hear your experience in what the, key pain points are as it relates to source and data management.

Betsey Zbyszynski: Yeah I, have to say years ago we only created source documents for the sites, they couldn’t even use their own. And somehow, over time, that evolved where it’s not necessarily a regulation, but it’s an accepted method that the sites now need to create their own. Then we need to review the, CRO reviews, then the sponsor has to review, so it’s a really long process. We need to make sure that the source documents are capturing the specific units that might be in the EDC system. There’s a lot involved in reviewing and ensuring that they’ll create the data that we need to be in the EDC. It’s a challenge there, and that can be time-consuming, and a lot of burden on the sites as well.

Simon Burns: Karina.

Karina Garcia: Sure on the sites, and what we tend to see, is our coordinators work so hard on the source to ensure every data point from the protocol’s included, only for us to realize, once we get into EDC, that they’re asking for so many more details that weren’t listed in the protocol. And, since we’re not able to access those EDC pages until, we have our first subject post-visit, ultimately that’s gonna lead to missing data, and that’s something the site and the sponsor never want to see.

leaves us scrambling trying to fix the source, trying to figure out how to capture that data late, and, on top of this, it opens just a huge flood of queries, which… Queries are their own unique language across every data management group and EDC system, so a lot of times the site needs to read between the lines, to s-… know what they’re getting at. And every time we get to our computer the… those queries just keep stacking up, so it, it’s a pretty large problem.

Dhruba Biswas: Yeah, I think the main issue is that clinics are generally not set up to document the requirements that are needed for research trials. What… Something is captured in normal standard of care. Research now is gonna be much more intense than what a doctor who normally sees a general clinic patient would capture in their notes. The downstream effect is that trials may or may not get the data that they need for their primary and secondary endpoint analysis, and if they do get that data, then it might have been added in later to the note which isn’t necessarily the best GCP practice.

And the downstream effect of both of these things is that data gets entered later than the visit day which means that analysis has to be delayed on the sponsor and and there is a lot of back and forth again over email. Nagging from data managers to the CRAs, CRAs to CRCs, to the PI, and there’s a loop that creates a lot of burnout. It’s not the most efficient way and it’s not really anyone’s fault. It’s just the way that the current system is designed to capture research information.

Simon Burns: Totally. One of the things that, I think, shocks a lot of employees when joined Vial, those who don’t know much about research before is, how much is still on paper. When they speak to sites and they go you created a PDF source, printed it out and then captured the information via paper and clipboard,” right? And that’s the way that we capture the vital information to determine whether a drug is efficacious. That’s all happening on, paper.

Now, the dream has always been a shift to digital source, and some kind of electronic source to capture that information. A shift away from paper, modernizing technology, and all the benefits that come with modern technology. But that hasn’t happened, and it hasn’t happened for a whole host of reasons that I would love everyone here to pine on. Maybe let’s go to reverse order, start with Dhruba. What are the reasons you think electronic source, eSource, has not taken off in the way that some people might have expected?

Dhruba Biswas: I think, primarily, that it’s not… hasn’t been, at least right now, the most functional way to collect research information. If you consider the environment that a CRC or an NP is working with, then they’re handling multiple patients, they’re traveling across a clinic, they’re collecting ECGs. If they’re the ones that are drawing the blood as phlebotomist, or they’re collecting vitals as an MA. There are a lot of different roles and a lot of [00:15:00] different overlapping priorities that happen at the same time when you’re running a research trial, so it hasn’t been the most practical in the way that it’s been used on a computer.

And there are some limitations that exist in the current realm of eSource that I think, most coordinators and research teams have just decided to keep the, as is on paper or documenting within their EMR as, their normal practice.

Betsey Zbyszynski: Yeah, agree, and clinical research industry as a whole is very conservative. We’re governed by FDA, which is a very conservative organization as well. Agency. I think change is, hard and can take time, especially in this industry. Even EDC, it took so long. O-… when, obviously, when I started as a coordinator, we had paper CRFs. Three part paper C- NCR CRFs, and even to get to this point with electronic data capture took, probably, took five to 10 years. I mean-

Simon Burns: That’s crazy.

Betsey Zbyszynski: … so I think that is a… that can be big roadblock. Change.

Simon Burns: Karina.

Karina Garcia: Yeah, I would absolutely agree, and then one other thing to take into consideration, a big hesitation from the site with embracing eSource is, each study already has its one new EDC system, one new IWRS, and usually an ePRO questionnaire system, so it can be really challenging if each coordinator has multiple studies. You have to become tech support, in a way, if your systems aren’t straightforward, if they’re not compatible, and every coordinator I know has spent hours on the phone trying to reach actual tech support for one of these systems, which is not something ideal.

The subjects can’t be waiting around too long, so if we don’t really have a real support system for these different programs outside of our initial SIV training, th- that’s a really big obstacle for the sites, and I’d say one of the largest hesitations as well.

Simon Burns: Thankfully at Vial we’ve, been focusing on this problem. Our engineering product and design teams have been working closely with our clinical operations team to do exactly what’s on the slide here, and shift from the typical site being in a trial that is on paper, with comes… that comes with it a lot of inefficiency a, high query rate, but just managing and keeping track of that paper alone is an administrative burden on the site and the monitors a world where the typical site is, on eSource.

And in order to do that, we thought long and hard about how to make it intuitive, how to save time for the coordinator, how to make it seamless experience for them to use. All in time and cost savings, both occur to the site as well as to, the CRO. Here’s a quick demo of what it looks like. And on a tablet or web interface a site has prebuilt source. Vial builds the source. You can go through the flow. It’s automatically validating information, it’s skipping ahead a few questions if there’s questions that are unnecessarily answered, given how you answered the question. And most critically, we’ve understood the challenges of the site. They want help, they want support. Really extensive training on the front end, also live support. If you wanna call or text chat the team anytime during the day, we’re standing by to help support the team.

Where this gets really exciting is is from the centralized monitoring perspective. If you’re a CRA sitting at one desktop, and you can see hundreds of sites, all of your visits in realtime, all your queries, all the data to be verified, this is a complete game changer for how a, team can run a trial. It means they can run more, sites per, CRA but also just have more visibility ensure that there’s higher quality data coming back from the site.

With that, I wanna thank you to the panelists. We’ll do one more slide and then jump to Q&A, but I really appreciate you guys taking the time today. And the last slide is just that, while Vial sp- spends a lot of our time thinking about electronic source technology to enable the site startup, we also spend a lot of time building technologies for patient recruitment.

Here’s a slide that talks about our patient recruitment channels. We run trials trial campaigns across digital and non-digital. Digital is Facebook, Google, other programmatic ad campaigns. Next door, non- digital. Radio, direct mail. As you can see here, out-of-home and bus and shelter ads. All of that is, is highly effective at driving candidates into a pool. We also do eMAR integrations, at which point we do automated inclusion/exclusion criteria filtering, call or text those, subjects and ensure that they’re… they come in to the clinic. This has been huge for driving speed and cost efficiencies in the trials.

Let’s jump over to Q&A. And we had two questions come in. The first is, how do you convince sites to use eSource? And yes, we have convinced sites to use eSource. We’ve now done it across a number of sites in our network. Tens of sites are, ne- now using eSource, and the number continues going up. It’s been certainly, I think, a long, road. There’s, a lot of technophobia as [00:20:00] Betsey, was mentioning.

It takes a long time to convince people to use the technology, but if you focus on their pain points, show them that this is a time-saver, show them this is more efficient, and you’re there to support them… This isn’t unsupported technology like a lot of people are used to. If you’re used to being told, “Here’s your EDC, 30 minute demo and then we’re gone,” this is not that. This is tech built for them, and once, I think, that’s made clear and that it’s actually useful, that changes the game quite a bit.

The second question is, what therapeutic areas do you operate in, and the, answer is we’re operating across a number of therapeutic areas. We have leaders in, Betsey, who leads our dermatology business unit. We have leaders across several other business units that lead across the board but we’re happy to have a conversation with really any, clinical trial. While we experts in many we, like to be able to help uh, and support in a lot of different ways for different types of trials.

With that, I think that’s all we have for Q&A. Thank you for attending our, webinar today. Thank you to the panelists for joining and being gracious with your time, and have a great rest of your day.

Betsey Zbyszynski: Thanks, everybody.

Dhruba Biswas: Thanks, everyone.

Karina Garcia: Thank you, everyone.