Webinar: Reimagining Clinical Trials to Deliver Faster, Higher Quality Trials for Sponsors

Simon: [00:00:00] Thank you all for joining us today for Vial’s on demand webinar, we’re joined by Rich and Luke to speak about how Vial’s reimagining clinical trials to deliver faster, more efficient trials for sponsors. Let’s kick off this webinar with a round of introductions. Rich kick us off.

Rich: Sure. Thanks Simon. I’m Rich McCormick, vice President of Oncology. I’ve spent the last 20 years dedicated to running complex oncology trials across project management and clinical operations. My last eight years or so have been focused on more complex early phase oncology and immuno-oncology.

Luke: Yeah, my name’s Luke Bogus, product manager here at Vial, helping build our end to end clinical trial technology platform.

have experience in start ups and big tech alike and jumped from Microsoft to reimagine clinical trial through tech.

Simon: Great. And I’m, Simon, Co-Founder and CEO of Vial. I come from a background in technology and product leadership. And, started Vial alongside my co-founder Andrew.

With that we’d love to share more about our story and how we’re supporting sponsors. Vial was founded on the mission to reimagine clinical trials and make them far faster and more efficient for sponsors. And this, mission really permeates everything that we do. Our core approach to execute on this mission has really been to one, build the core founding team and raise the capital. We’ve now raised just over $100 million in capital to build Vial. And second, we’re a very interesting mix of cultures. We have a, leadership team that comes from large CROs and sponsors bring with them decades of experience in indication specific, therapeutic area specific, knowledge that they apply to clinical trials, as well as a team of engineers, product managers and designers from, Silicon Valley and leading technology companies.

The two teams have come together to build a platform, that drives efficiencies across the board. Now this isn’t DCT. This isn’t decentralized trials.

We work and, operate with sites and have worked with before. These are leading academic medical centers, large private practices who run clinical trials. We just enable them to be far more efficient. And we’ll talk today about how we do that across site start up, across data capture, across really everything in a clinical trial our technology platform has been deployed to make more efficient. all in the goals of making trials faster and delivering for sponsors.

So with that I’ll hand it to Rich to talk about, the leadership team across therapeutic areas that we brought together to support sponsors.

Rich: Sure. Thanks Simon. as mentioned, I’m o- overseeing, the development of our oncology therapeutic area. Uh, but working closely with me is Lisa from CNS, Sarah from GI, and Amy from ophthalmology to help us lead these therapeutic areas to deliver trials for you. Within each of these therapeutic areas are dedicated staff that we have. Uh, right now PMs, CRAs, who are working both here in the us and globally, especially as we look to expand in, 2023. our teams are really dedicated to the CRO space, coming from at least five years of, background working at other CROs and even at, the site level, to really sort of expand on what they know and how complex it is to run these clinical trials.

It really creates a a passion for our technology. So within each of our therapeutic areas, we do have really experienced ClinOps teams so our PMs and CRAs that are available to be assigned to your projects. Our PMs and CRAs come from a mix of backgrounds. some with traditional CRO experience, but we also have teams that have come directly from biotech, uh, and also that come from the site level. So we do use that mix of experience to really apply to our technology platform to make sure that it’s applicable and meets the expectations for what our sites are expecting to see. Luke, would you like to go into the technology platform?

Luke: Awesome. Thanks, Rich. when we set out to build, an end to end clinical trial platform we had two key ideas in mind. One is what would it look like to build one connected system all the way from site start up to recruiting patients to managing the patients and closing out the trial? What does it look like to have that be one connected, streamlined platform? And then two, how do you impose intuitive thoughtful design on these products that are, typically legacy or unintuitive, things that should take two clicks take seven. So taking a user centric approach to the design of our platforms. What if you combine the design with connected systems? When you bring together connected systems and intuitive design, we see that our technology is able to run global trials efficiently at scale. There’s three key pillars to our tech platform, the first being site start up.

Site start up is 100% digital onboarding experience for our sites. This helps our Vial team, actually take a site start up board to compile a list of all the necessary documents needed to onboard a site for IRB submission, et cetera, and move it all into the cloud. So first, sponsors are able to select sites from our preferred site network or even bring a site of their own. For selected sites in our study, they get a link to our onboarding application. This onboarding application then directs the entire flow of the onboarding experience completely digitally from reg packet, to budgets, to CTA. It’s all done, via the cloud. There’s no file transfers via email, and we find that, this offers a lightening fast experience for our sites and we’re able to activate most sites in as few as 30 days. So, gone are slow [00:05:00] response times, random versions floating around in email, and we move it all into the cloud. It enables real time editing, fast approvals, and obviously the entire process is secure.

The second key pillar is once we have sites onto our platform, what does it look like to deliver an intuitive, simple experience to actually manage the trial in the first place? And so our e-clinical suite that connects our Vial e-source, our Vial EDC, and our ability to bring in our in-house software engineers to be dedicated directly to your trial to help with builds, support and integrations, those three pieces come together to enable us to deliver high quality data through connected data capture and review.

The first key pillar is our Vial e-source. Out with paper, in with e-source. We find that paper source is an archaic data capture method. This often leads to long build times data entry errors and delays in data review, versus if you’re able to embed the data input in with seamlessly in the visit.

We’re able to radically change the way that data is captured throughout a trial. Our eSource enables intuitive UI/UX that has data validation and rules logic on entry. skip and conditional logic depending on the type of answers that are inputted into the system, on entry SDTM control terminology backed by CDIS standards. And all to be said, this enabled us to not only embed data input flow directly with the visit, but it also enables direct data capture directly into our electronic data capture system or our Vial EDC.

Simon: Quick point I wanna- I wanna make here before we move along, very difficult to get sites on boarded into new technology. We spent a lot of time working closely with, sites, hearing their needs building the system with their needs in mind. typically CROs will push it to the sites to create source. Source ends up being very different from site to site. And when we’ve sat down to say, let’s reimagine your visit experience. Let’s make it faster, r- reduce timelines. Let’s insure that it doesn’t show up, as a query later on. It’s really been a- kind of a game changer for, sites and how they think about technology.

Luke: So our direct data capture then flows into our EDC, where we bring consumer grade experiences, design and performance to eClinical software. Our EDC is built on next gen technology and infrastructure. It’s all cloud native, so it’s global ready, has built in data protection and is compliant for 21 CFR Part 11, HIPAA, GDPR and others. And with that intuitive design, we’re able to actually leverage our in-house technology team. And with that technology team being in the same room as the CRO, we’re able to build exactly for not only the needs of the CRO operations and improving that, but also for the needs, directly of our study. the Vial EDC has all the EDC features that you would expect. Not only is it intuitively designed and built no that cloud-native infrastructure.

We have a full suite of robust user permissions and roles. We have the ability to input dynamic ECRF, through easy data visualization and data input. We have the full query management and data management functionality from audit logs, uh, data lock, data freeze, et cetera. And then a really flexible system for us to export data and the data and finally we have a flexible dashboard and data export system so it’s easy to report out the progress of the study directly from EDC data. Vial EDC goes toe to toe with all the big players in the market. You would see here that all the key features that you would expect from an EDC are present in the Vial EDC .

Simon: What really gets us excited about our end, platform is what it unlocks in terms of, making trials more efficient. So first, once you standardize all of the, data input into the system, you have sites going through site start up, with structuring all of their document uploads and, information, as well as the visit, it really enables, a shift forward in a lot of things that have already been happening but we can accelerate those trends.

So for example, centralized monitoring. centralized monitoring has been held back by paper still being at the sites lack of structured high quality digitized information coming from the sites. Now that Vial is enabling that with our technology platform, it really enables us to move more visits centrally than were previously happening in person. As well as a lot of the work flows that are happening at the CRO. A huge share of the costs born in a clinical trial are for CRAs and PMs who are moving documents around unable to find the, the correct document. And that cost gets passed back to the sponsor.

Now once everything is streamlined, work flows are automated, we can start reducing the costs on CRAs and PMs and pass back those cost savings to the sponsor. Before we move to our final few slides, I wanna briefly talk about our patient recruiting team. Our recruiting team is dedicated to your clinical trial. They’re highly experienced. They come from years of running clinical trial recruiting campaigns. And we have experience in operating in, a lot of different environments, whether it’s a rare disease where a patient advocacy groups make sense for us to engage or more common indications where Facebook, Google, direct mail, radio, are channels that we with we’ve also built just over 75 integrations with leading electronic medical records. And so whether we’re working with an academic medical system, uh, in which case we’re gonna work with Epic, Cerner, Allscripts, or a small private practice who’s doing clinical trials where Flatiron or I Know Med, Modernizing Medicine, uh, Nextech or a series of other private practice focused CMRs, are where we’re gonna wanna plug in, find patients who are a fit for the inclusion/exclusion criteria, map those to the clinical trial and enable them to be recruited into the [00:10:00] trial.

Altogether, a lot of, tools at our disposal that we deploy into the clinical trial to ensure that we can, deliver on the timelines that we commit to with, sponsors With that Rich take us home with, fixed fee pricing.

Rich: Sure. Thanks, Simon. So as you can see, our technology is differentiating. In addition to that, we’re committed to being different from a pricing standpoint as well. So we are offering our sponsors fixed price agreements. This is something that biotechs have been asking CROs for many years. we’re really excited to make this commitment. We wanna basically be able to share in the risk for your project. We want to be accountable for the commitments that we’re making within these agreements, and I think that’s something that our clients are really going to appreciate.

So we have our technology platform, our commitment to, fixed price costing. feel that we’re able to do this because we know we’re gonna be able to run your study dramatically faster. So in addition to being able to save you time, it’s also going to be able to save no the costing. So the Vial platform that Luke has presented in addition to our commitment to fixed pricing, we feel that Vial is going to be able to drastically improve your clinical trial experience. We know that we’re going to be faster and we know that we’re gonna be more affordable and that’s what’s making Vial a, next generation CRO.

Simon: With that, thank you all for watching our on demand webinar. Luke, Rich, thank you for walking through the platform and why sponsors have been noticing Vial paying attention and working with us. love to talk to you about your programs and how we can help deliver faster, more efficient trials for you.

Feel free to reach out to all of us. We’re first name at vial.com. And thank you once again for watching.