Demo: The Vial Technology Platform

Hey, there. My name’s Luke Bogus. I’m a Group Project Manager on the Vial Technology team and I’m really excited to share more about our Vial Technology Platform, our end-to-end clinical trial technology stack that helps power our faster, more efficient trials. We’ll talk through a quick overview of the system and some of the results that we’ve seen with our platform, then we’ll jump into the site startup portal, as well as our digital visit capture technology. So, generally speaking, the Vial Tech Platform combines connected data and intuitive systems to run global trials efficiently at scale. The reason that we built our technology is the same reason that we founded our CRO in the first place. Which is, how do we make a tech-enabled CRO? How do we rethink the legacy processes and the legacy systems that exist in the clinical trial world today and help supercharge those and be more faster and efficient through technology?

We thought about this in two key ways. We wanted to first, solve the problem of legacy systems. A lot of the systems that are most popular in clinical trials today have been around for decades. But the problem with that is that means that the technology [laughs] itself is decades old and pretty archaic. That sees itself through a few ways. One, build timelines. Actually building the database, building the ECRS for your study, take multiple months. And if you want to make a change, good luck, that’s also going to take a couple weeks and months as well. When you finally get the study up and running with those archaic systems, those archaic systems are then sent to sites to have to try to train on, try to use and just becomes a frustrating experience for sites, because the technology itself is unintuitive, it’s buggy, it’s hard to use and it’s not a great experience for sites. Which then results in potentially lower quality data, because it was a frustrating experience for sites having to enter the data into these systems.

Not only are there legacy systems in the world, there’s a legacy process when it comes to clinical trial technology in the first place. Oftentimes, we see upwards of eight unique systems, different vendors, different technologies being used for one clinical trial. And so, there’s no central source of truth for the data for the course of your trial. As a CRO and as a sponsor, we have to get all those technology systems to talk to each other. Uh, good luck, because the data structures are different. If you want those systems to talk to each other, it’s going to cost an arm and a leg. There’s tons of different timelines. Big bloat when it comes to timelines, cost, et cetera. And what happens is that us as a CRO and you as a sponsor, it’s out of our hands. It’s in the hands of these vendors. Those vendors that have full control over the data, have full control over the timelines and full control over the cost of your study.

And so, what we thought about when we were building our technology platform is, what if you can actually embed a product team and a software engineering team within a CRO? What if the technology that is used for a trial by a CRO is built by that CRO as well? We know the pain points better than anyone else, so why not build a software team around that and build the technology for use in our trials and ultimately in your trials, where we can control the cost of the study, we can control the timelines? There’s no vendor dependencies. We control the data, we control the builds, we control the entire experience through a faster, more efficient and intuitive to use clinical trial technology stack. This stack follows the sites from start to end. We actually have technology that helps onboard sites fully digitally. Once those sites are onboarded, we help actually capture data in the digital fashions, so no more paper.

And then finally, we’re actually able to deliver analytics to you as a sponsor in real time. Since all of the data that we have is digital first, built in the cloud, this offers 24/7 access to all key study milestones, KPIs and data throughout the course of your study so that you can see your study’s success. And what we’re seeing so far is that it’s working. The site startup app we’ve seen on an average takes down activating sites to nearly 30 days is all. In the old model, when it comes to activating sites, this involves tons of email chains, slow response times, random attachments to random email threads. There’s Excels here, there’s Word docs there. There’s red lines here, comments there. Super confusing. An absolute black box on what’s the status of the sites being started up? How close am I ready for FPI? All of that information is just contained in someone’s email inbox.

But, here at Vial with our technology forward thinking when it comes to running our CRO, we like to think about site startup as being email-free. We actually funnel this all through a portal that enables us to have real time collaboration with sites and us. We optimize workflows, where there’s no attachments being sent back and forth and always contained within our site startup app. And it actually offers real insights at a site level and a document and task level to you as a sponsor to know how close you are to study activation and site startup. So, that’s just one example of the results that we’re seeing with our technology stack and with our site startup app, which we’ll talk more about in a minute.

Once those sites are activated, we then deploy our digital visit capture technology directly to those sites. This is essentially our eClinical technology stack, our electronic data capture and our eSource technology. Basically, it’s one portal, one compliant connected system that enables us to achieve higher quality results. We do this through super fast build timelines for your database and for your study. We’re targeting around a four week build from protocol finalization to go live. And then thinking about if one connected system between digital first data capture of our eSource and direct to data capture solutions, as well as within the EDC automatically structuring data on input by structuring data straight to SDTM and having real time analytics and reports built into the EDC itself. All this coming together turns out into higher quality, more real time data collection, which leads to a better outcome for your study.

I’m excited to jump into those right now. The first key part of our Vial Technology stack is our site startup portal. As we talked about earlier, a lot of site startup processes today are very archaic. Highly manual. They live in email. There’s tons of back and forth long email threads with every single site. There’s floating documents everywhere. Within these documents, the Word docs, the Excel docs, there’s random red lines and comments. It’s really confusing. It’s confusing to know what is the status of the site startup progress for every single site. It’s really frustrating and not clear to understand how close we are, what document’s the most recent document, which one should be routed into DocuSign. There’s all these random processes that, again, have no central understanding of what the statuses are, what is the source of truth, because they all live in email.

And so, one big thing we think about is rethinking the entire approach to this. What if it were to look like to take an entirely digital, self-serve approach to sites onboarding to studies? And so, this is where we really built the site startup portal. This enables lightning fast site activation, through a digital first approach to site startup. Essentially, this is a cloud-based easy to use site portal. Instead of sending an email with a bulleted list of all the documents they need to attach via email, we don’t do it that way. We send them one link. That link is directed to the site startup portal. They have simple access to their site’s portal. And within that portal, they’re able to see all the tasks that they need to complete.

They’re able to see what tasks are pending their action, what tasks are pending us as a CRO’s action, what tasks need review, what things need updated, and all of those tasks are a combination of forms where they’re able to simply fill out information via a form. They can also upload documents. And then based on the form uploads, based off of the document uploads, that actually turns around for immediate signature through our integrated DocuSign component. And so, everything from essential documents, red packets, CTA, budgets, point of contact, this is all facilitated at the site startup portal. So, gone are the days of the random … Bunch of random miscellaneous emails. But rather we have a digital first approach to the way that we are onboarding sites to our studies.

So not only is this an intuitive experience for sites and not only does it make it much easier to manage, but on top of being able to more easily manage and on top of that being a more simple experience for sites, this actually enables us to have more real time insight into every single task, document that is being asked for during the site startup process. And by virtue of that, being able to know the status of where all these tasks and documents live. This way we can know if it’s been sent for review, if it’s been fully reviewed, if it’s fully complete. It’s more transparent in real time statuses between both the sites, the CRO and then back directly to the sponsor. We’re able to relay to you a per site and per task basis what the status of onboarding and activating the sites for your study are.

In addition to that, this also provides one single home for all the key study documents. There’s no random email threads with one important document in this email, another important document in that email. All documents, all key information can be uploaded, editable, renewable, approved within the one single portal. And in addition to that, all the documents that are uploaded, all the signatures that are approved, all the DocuSigns that are routed are immediately being able to then port directly into our eTMF for instant storage, which makes things so much simpler for both the sites, the CRO and then ultimately for you as a sponsor.

And as I mentioned for you the sponsor, the entire purpose of this is to provide better insight into the study’s success of your study. And so, by us being able to track with a digital first approach to site startup, this enables us to give you a bird’s eye view into the success of your study. And so, you’re able to drill down on a per site, per task basis to understand what the status of these items are. We can also work with you to actually customize this analytics dashboard to the needs of your study and the needs of your management, what key KPIs and milestones would you like to track? How can we track the site visit statuses and enrollment statuses, the study and site tracking, all the key milestones, vendor management? This is all information that we can now provide to you in real time via our study analytics dashboard.

So, bringing it all together, our site startup is a cloud-based solution that actually enables sites to onboard in as few as 30 days. We’ve heard great feedback from the sites because this eliminates manual work and administrative burden on the sites and on the CRO side. It’s simplistic. The sites know exactly what they need to do. They can self-service their way through the onboarding experience. There’s no random last second emails or this last second document, because all the tasks and all of their dependencies are fully tracked on the portal. They know what s-, what document’s already been submitted. They know what tasks need their attention and they’re able to know when they’re fully complete and fully ready to be onboarded to the study, so it’s all clear and transparent through the site startup portal. And so, this is really what enables our quick, fast site startup activation. And then ultimately, when sites are fully activated into our studies, this then is when we introduce the digital visit capture technology to all of our sites.

Next up is Vial’s Digital Visit Capture technology, which is our take on the eClinical software suite. eClinical’s anchor tech piece is the electronic data capture or the EDC. The EDC is the core place where all the study’s data is managed, stored, structured, reviewed and cleaned. However, this data often comes from multiple different places. First they come from multiple different technology systems. What we’ve seen is on average there’s an average of around eight different tech products used throughout the course of a trial. Some data goes into this portal. Other type of data goes into this app. And at some point, the sites are expected to transpose that data manually from those different vendors and those different products back into the EDC. And not only do they have to transpose data from different products into the EDC, we also see a lot that sites actually still use paper to capture a lot of this really important information.

And so, that’s another thing that we’ll talk about much later on. But generally speaking, there’s a lot of different sources of data out there. The EDC is expected to be the one singular place to manage, store and structure the data. However, these systems and these processes and especially paper, the data doesn’t really talk to each other. There’s massive delays in review. They don’t integrate. And so, when we went out to build an eClinical software stack, we knew that there had to be this principle of connecting data capture from all these different data sources and being able to review and structure it into one central location. And that location is the Vial EDC. Generally, we have built the next generation clinical data suite. This is anchored by our feature-rich electronic data capture. That has all the features that you would expect in an EDC and is supercharged by a few things.

First, it’s supercharged by our direct data capture and eSource solutions, where we actually send tablets directly to sites where those sites can input data directly in real time via the tablet and it automatically records directly to our EDC. In addition to our direct data capture, we also have an eSource solution where we’re able to integrate via API or other data transfer methods directly into other portals and to other products. We also have a software integration platform where we can integrate with products like an IRT. With all these things in mind, this is how we’re truly making the Vial EDC, the one single home for study data throughout the course of the trial. No more 10 different logins for 10 different systems. No more some data’s here, some data’s there. The Vial EDC is the core place to manage and structure and view data.

On top of that, this EDC is built by our Vial Technology team. Which means that when the Vial tech team has built the software from the ground up, that same team is resourced to your study to also build the system and study database for the needs of your study. So, because of this, what we see is around an average of four week build times from final protocol to study launch. Super fast compared to months and months long that we see with the other archaic systems. So not only do you get the resources of the same team that’s built the product, with this we also have the same kind of tech-forward approach in mind. All eCRFs are built on CDISC standard, which enables us to more simply structure and prepare the data for submission directly on input.

And the entire product is fully compliant, secure and encrypted. Now, we adhere to the principles of 21CRF part 11. We are HIPAA and GDPR compliant. And the entire system is built in the cloud and fully is managed by our robust audit trails and user permissions management. So, the entire system is fully secure and fully manages all the data throughout the course of the study. By enabling simple data entry for sites, and by aggregating data from multiple different data sources into the one home that is the Vial EDC, we’re able to offer simple oversight and simple management on this data. And so, the entire product has the full data management review feature stack, where every single data point has the ability to be SDV’ed, verified, reviewed, issue queries. Once the data’s ready to go, we can freeze data for interim analysis. We can lock entire forms and entire visits. We can provision PI signatures. The entire data management and review stack is fully built into our product, as well as all the audit trails, to make sure that the data is ready to go for eventual submission.

So by having a per data point, data management feature, what we are able to also do is we have a per data point status. Every single data point, we’re able to know if it’s verified, if it’s reviewed, if it has a query, if it’s been frozen. And those data points aggregate together to offer really robust visit and page statuses for both the sites, for us as a CRO, and also to you as a sponsor to where at a data point level, at a procedure level, at a visit level, at a subject level, at a site level, you’re able to see the statuses of the entire progress of the study. You can see what visits are still in progress. You can see if there’s any target dates that were missed. The date was supposed to happen then, the visit didn’t occur. Those are things that we’re able to signal within the app and send notifications. We can know what data points are in review.

We can know what data points are missing. This is the type of information that we’re able to bubble up to sites so that sites can know exactly what they need to take action on. And for us to be able to communicate to you the progress and the status of the important data, throughout the course of your study. And that insight is reported in real time to you. Gone are the days of random Excel trackers that are hopefully sent once a month by the data management team. Instead what you have is you have a live portal with 24/7 access to see the real time visibility into the status of your study. Our product is a full analytics platform which is connected directly into our EDC. And we have some … We have tons of pre-built dashboards already. Things around subject statuses, query statuses, visit status, deviation tracking, AE and SAE reports, data cleaning statuses, lock statuses, et cetera.

We have a full suite of data management statuses and charts that are already provisioned into our product from day one. But in addition to that, we can actually work with you directly to understand the custom needs of your study, the custom KPIs, the custom filters that are needed for you and the things that you prefer to track. We actually have that flexibility to work with you so that we can combine our out of the box reports and charts and combine that with the needs of you and your study and the KPIs that matter to you, to again, offer you the ability to see real time access into the status of your study. Vial’s data management processes and ability to provide real time updates and statuses to you is further supercharged by Vial eSource. We talked earlier about how data throughout the course of the study comes from multiple different places. Some data goes here. Some data goes there.

And one data source that exists a lot on sites today is via paper. What happens is that these sites print out source documentation. We then take this blank paper into the visit and we have sites actually input this important patient data onto paper, line-by-line, answering all the questions, hoping that they answer all the questions right. Hoping that they didn’t scribble the wrong number down. And what happens is that paper then ends up on a desk with a stack of other paper source documents and we hope over the course of today, of this week or even this month, that at some point someone will transpose that data from paper into the EDC. And it’s not until that data is into the EDC that we know the status of that site, that we know if there’s any incorrect data points that have been entered into the EDC.

So, what happens is that when we have a paper based source collection process, this leads to massive delays in review. It forces us to do in-person monitoring and there’s a massive risk in data quality and data capture if we go through a form like paper. And so, what we do is we actually have the ability to ship tablets directly to sites and built onto that tablet is a Vial eSource app. Instead of bringing paper into the visit and entering data into paper, we actually encourage sites to bring the tablet directly into the patient experience. And via the tablet, they’re able to input data directly, simply through a tablet and web flow-based experience. That eventually on entry will record the data directly into the EDC. This enables us to have immediate review of the data and it enables high quality results. We’re actually able to do is when we’re able to input data into the visit itself, we can catch and do edit checks on the data in real time. If we notice that they put an erroneous range of a lab, we can actually see that on entry.

If we see things like data types and data conformance being wrong on entry, we can’t catch that on paper. But we can do that in real time via the direct data capture solution. In addition to that, all these forms are also backed by SDTM. So, immediately on data input, all this data is SDTM conformant and even closer to be ready for submission. And so, not only is it easier from a data cleaning perspective, but it’s easier also for sites. Rather than having to fan through multiple pieces of paper, we have an intuitive workflow built into the capture itself. No more fanning what 10 procedures do I have to do today? What 50 questions do I have to make sure I answer today? The tablet actually guides the the site user through the experience of what information needs to happen next. Built into all of our flows is skip logic, conditional logic, data validation checks, data types.

It’s all built in right then and there so that there’s no issues and that it’s super easy for sites to use, helps increase their efficiency and also ultimately, reduces protocol deviations for your sites. And so, by making it more simple for sites to enter data, by having that data be more clean on entry, by having that data be entered at the same time the visit occurs, this enables us to provide that better experience of being able to show you statuses more so in real time. Being able to conduct data cleaning exercises more promptly and by being able to ultimately deliver better, faster and more efficient clinical trial data and clinical trial outcomes for the course of your study.

And that’s really what the Vial Technology Platform provides, is by bringing together connected data and intuitive systems by means of our site startup portal, which eliminates manual processes and emails from the process and rather has a digital first self onboarding experience for site startup documentation and tasks. And then once the sites are activated, they use the Digital Visit Capture Platform, which is anchored by the Vial EDC and supercharged by the Vial eSource solutions, direct data capture solutions and our ability to integrate with other data systems and other eClinical systems as well. Which ultimately gives you as a sponsor piece of mind being able to access your study analytics dashboard to see study milestones, study progress, database lock progress, and study success progress in real time via our dashboarding solution. We’re always happy to talk more about our technology solutions. Always feel free to reach out, luke@vial.com. I really look forward to hearing from you soon. Thanks.