Join Luke Bogus, Head of Product, Sarah Ruiz, Director of Product Management Operations, and Zain Dewsi, Lead Software Engineer at Vial as they discuss the challenges in running clinical trials and how they prepare for tech deployment to sites.

Luke Bogus: My name’s Luke Bogus, I’m the head of product here at Vial and I’m really excited to be talking a lot about our faster, more efficient clinical trial infrastructure, and we reimagine Clinical Trials through technology.

I’m joined by both Sarah Ruiz, our Director of PM Operations, and, Zain as well, uh, one of our awesome software engineering leads to talk about historically what are problems throughout clinical trials and how we leverage technology, to solve a lot of those problems.

 Lots to talk about. Let’s just dive right in. First question is for you Sarah, in your years of experience running clinical trials and being a part of it what are typically some problems that, come about when it comes to activating clinical trials, getting trials ready for first patient in, what are some typical rate limiters that we see, generally in kind of the clinical trial landscape?

Sarah Ruiz: Yeah, I think one of the, most common struggles that we have is just the amount of moving parts. And so it’s really nice to, be able to take those moving parts and zoom in and out from a technical lens and be able to organize everything in one platform and, have some automated workflows that… we’re never gonna get rid of the human touch, if you will, but certainly we’re strengthening the tools that we have not only on the engineering product and design team, but ultimately on the clinical operations side to make sure that we have all of our ducks in a row before we launch a trial. And the technology that we work on and have in place really do drive that point home.

Luke Bogus: Got it. And so I’m curious you talked about technology has technically been used in clinical trials for decades now.

but we at Vial think we’re kind of using it in a really unique way. Maybe you can kinda touch on some of the things, some of the ways that we’re reimagining clinical trials with our technology on?

Sarah Ruiz: Yeah, absolutely. This is actually near and dear to my heart, I was a CRC when I first started 10 years ago and have been exposed to a lot of the ups and downs of clinical research.

And I think one of the things that all clinical research technology has to do is be compliant. And so we’ve really focused our energy getting up and running on Part 11 compliance and FDA regulations.

But a lot of the times, we have this vendor over here and that vendor over there, and having a third party vendor, while can be valuable can also be a limiter and I often found myself as a clinical research coordinator saying, “Why aren’t these two things connected? I’m duplicating my efforts, I have 40 different log ins for one trial. I can’t keep up with all of this.” And I think one of the things we do here at Vial is we really take that into consideration and make sure that we have the least amount of log ins necessary with the most impactful products necessary. All of the integrations that you can possibly think of we wanna work on and we do work on. So that alone, gets us leaps and bounds ahead of where the industry was.

Luke Bogus: Yeah, totally. When we were thinking about building our entire product suite EDCs have been around for a long time and there’s definitely tons of EDCs in the market. And while we do take a unique approach in how we built and developed and leverage our EDC, which we can talk about later, um, we knew that not only having a ton of in house eClinical products were important such as EDC, eSOURCE, ePRO, et cetera. Um, because of that problem that you just mentioned, that e- every tech company thinks that they can solve all the problems in clinical trials with just their one stack. While that’s definitely the goal that’s not always a reality. Sometimes you have to use other vendors, sometimes there’s other pieces of data that we wanna collect and other methods of data that we wanna integrate into our systems. And so, that’s kind of I guess where the beauty of having an in house software engineering team like Vial comes into play, which is we are both a CRO as well as a product company. So we have built all of our eClinical technology in house, but we recognize the needs of, certain trials have their own certain custom requirements. And so that’s when we can pull in folks like Zain to leverage our highly customizable infrastructure to meet the needs of any given study.

And so Zain, I’m curious maybe like from your experience working with a lot of our clients and a lot of the kind of unique requirements that our clients and our sponsors need. Why don’t you walk me through a most recent process we had working with a vendor to integrate their data workflows into real time directly into our, uh, platform? You wanna talk a little bit about that experience?

Zain Dewsi: Yeah, absolutely. So one of the vendors we recently worked with was 4G to build an integration for their IRT platform for one of our ongoing studies. This was a pretty involved process from figuring out the requirements for how we’re gonna collect the data, building out API endpoints so that we could integrate with our software, and then finding ways to display it for our users so that they can see where the data is coming from. There was a lot of, obviously back and forth, lots of email threads. But in the end, because we have our own in house software engineering team, we’re able to make our platform as customizable as we want it to be. That also means that we can customize our platform so that it works for any study based on the sponsor’s needs. We can also provide real time data updates, we can provide different ways to visualize the data, we can build our own reports. And all of this is accessible to our clients just at the click of a button, which is a lot, [laughs] a lot easier than some other platforms.

Luke Bogus: Absolutely. Yeah, having the power of that in house software engineering team to meet the custom needs, uh, of our sponsors is definitely, uh, one of the big value adds of Vial. But another value add too is just that, um, ’cause we have like a technology forward approach to how we prepare the database and get it eventually ready for go live, uh, we actually promise around a four-week build time for a lot of our databases. Um, part of that is due to our ability to quickly integrate with other vendors, but, um, other parts of it is our unique approach to how we prepare the eCRFs, prepare UAT and ultimately get ready for go live.

Sarah, do you wanna talk a little bit about our database build process and how we leverage our no code builder solutions to meet our high customizable needs for our studies?

Sarah Ruiz: Yeah, absolutely. I think obviously the engineering team paving the road here really speaks for itself, but typically with a study the first thing you get is a protocol, right. And even if you don’t have that protocol finalized yet, you have a general idea of what assessments are gonna be needed and the primary endpoints of a study. So we start with that, create eCRF specifications outside of a platform. That way, we can move as quickly as possible and get the feedback from the sponsor and other partners as quickly as possible. And then we use premade templates that are already built to CDASH And CDISC requirements so they can easily be tabulated in the future, with little tweaks that are based on the protocol. We deploy that. That usually takes about one week, honestly, from start to finish, one to two weeks. Then the rest , we spend a little face to face time with the sponsor doing UAT. We have, uh very, thorough [laughs] scripts to complete our user acceptance testing to make sure that all the data’s being collected correctly, It’s being displayed correctly, it can be reviewed properly. And all of that takes a matter of weeks primarily due to the fact that it’s a very low code solution. So even I can do it. And also because we have you were just mentioning, such a [ laughs] just a vital and very efficient engineering team. I’m still blown away every single day with my whimsical dream state ideas of “You know what would be really cool, is if we could do X.” And whether it’s Zain or somebody else on the team, they’re like, ” That is cool. I just did it just now. Do you wanna see?” And I’m like [laughs], “How did you do that? That’s amazing.” and that’s literally an example from today. So real world examples coming in to this webcast. But yeah, essentially, we start with a specification and we end up with a build and it only takes a matter of a few weeks.

Luke Bogus: Absolutely, yeah. And you mentioned it really well too, it’s kinda like that collaborative process. The quickness to us comes from the fact of you making in sure that we include the proper stakeholders on the sponsor side iteratively throughout the entire process. I think a lot of other, um, CROs that you might work with is two-fold. One, uh, the technology that you’re given, you get what you get.

it updates a couple times a year and if y- it doesn’t have a feature that you want, tough. Um, on top of that too, the CRO understands your requirements and then we’ll spend 8-10 weeks preparing the database build for you, come back with a proposal and then, “Wait, you missed a bunch of things.” And like, “Wait, can I add this?” And, “Oh, it’s too late.” “Oh, here’s a change order,” right?

For us, we believe that quickness actually comes in more touch points, quickness actually comes through transparency, quickness comes through collaboration. And so, um, for us to be able to quickly build the database with our no code solution, Zain, we love you, but sometimes working with engineers takes a long time. And so making it such that our team can quickly make any database adjustments, quickly edit and approve ECRFs and do so iteratively with sponsors allows us to go live quickly, which is kind of a last point I’d love to touch on, is what does that database unlock or rather that database go live process look like, Sarah? We have the eCRF specs are signed, UAT is complete, now it’s time to actually get this to site so we can enable them to, perform first patient, um, activities. So maybe you wanna walk through a little bit about our deployment process, our training process and how we kind of get sites, um, ready to go and acclimated to our technology?

Sarah Ruiz: Absolutely. I think that’s one of the beauties of our EDC is that we can do those two processes semi independently. Our user training and our user onboarding process is very asynchronous because we know how many emails and how many meetings and how many patient visits a user can have a CRC or a PI, especially a PI, can have in a day. And so we make sure that one those users get invited to the platform and getting invited to the platform immediately kicks off training. It’s an automated workflow. Once they get proof of that training, they’re then immediately given access to the study. For one user that takes 13 minutes to train roughly while maintaining compliance. And then it takes us a matter of seconds to give them their study. So the beauty of it is that once the study is UAT’d and passes all of our requirements, it’s already in production. So we can essentially take away all the dummy data that was added as part of that UAT scenario and start fresh with our clinics and our users. And there’s really no down time from getting the build updated, getting this UAT signed off on and the specs signed to having users in the system and entering data.

Luke Bogus: Thanks, Sarah. Yeah, and totally while you get to spend all of your time on, uh, preparing the database, um, and that we don’t have to bother our engineers on first study requirements in that way, our engineers can focus on making, uh, the best, most usable e-clinical solution out there. And so since they’re not bogged down with random requirements to build the database, they can focus on building the best, uh, system in general.

And so, Zain, how does our engineering team think about that? How do we approach, uh, the notion of trying to make the most easy to use, highly usable, high performance EDC and e-clinical solution in the market?

Zane: Yeah, so, our team believes that we should be shipping things as quickly as possible. But like Sarah mentioned, we also do have a very rigorous testing process. We do both manual and automated testing so that we can be sure that before something even reaches the user, uh, it’s been fully tested and we can be confident that nothing is gonna break. That being said, one of the things that really separates us from other companies is that instead of putting out new features, like, maybe once or twice a year, our team is putting out new features pretty much every month, oftentimes, multiple times a month. And the users don’t experience any downtime because of our rigorous testing. And because we ship things very quickly, that also allows us to roll back features in the rare, case that, if something needs to go back to the way it was, we can very quickly do that because of our system. So that’s definitely one of the biggest thing that sets us apart.

Luke Bogus: Absolutely. Well, thanks so much for tuning in. it was great to hear from both Sarah and Zain about how we take a digital first process to use technology to reimagine clinical trials through fast database builds, digital first training and preparation for sites, and also, working with other vendors and other data providers to provide real time data integrations directly into Vial’s comprehensive eClinical platform. So until next time, Sarah, Zain, again, thank you so much for your time, and we’ll talk soon.

Sarah Ruiz: Thank you. Happy to be here. Talk soon.