ATC Webinar

September 15th transcript extract

Welcome to everyone who joined today, and thank you for taking time out of your day to join this webinar. Over the past two years, we've all seen DCT in decentralized clinical trials go from edge case to main case and clinical trials in general have had a spotlight on them throughout the world and have never been more important or more well known across the globe. I'm excited to share with you today, a variety of information that will hopefully help your organization, embrace and accelerate your DCT or hybrid clinical trial journey. As Lisa mentioned prior to joining Medable, I spent a number of years in the medical record world. I served as executive on the implementation team at Epic the largest EHR provider here in the US, and I worked there during the industry's period of incredibly rapid growth and adoption of the HR perspective, when I was there we were hiring nearly 1000 people a month to keep up with the growth that we had a number of organizations that we worked with that adoption all occurred as a result of a really large catalyst. The federal mandates and some incentives around that, and since the industry has never been the same. When I joined this industry a little over three years ago I saw a lot of parallels between hospitals, and the clinical trial technology environment. I don't think any of us really anticipated what the catalyst would be to lead to really rapid adoption and innovation in this industry, but now we're seeing the same type of dramatic change, and the pace of innovation that medical records and many other industries have undergone before us. I think this was great for us as we can use this blueprint from other industries, help us be successful as an industry as well. 

When you look at all those different cases in almost each every single case, the organizations who proactively prepared and educated themselves on the use cases and embrace that technology adopted it for what it was intended to be used for rather than trying to retrofit what they were doing before into that move to lightyears ahead of the others. So today, I'll walk you through a brief background of kind of medical. history and our experience with DCT, RD, you know, a few years ago, and what has really, you know certainly picked up post COVID And during COVID, and then share with you in more detail, but really the bulk of today's webinar is focused on the best practices that you can take and immediately implemented leaving here with your organization, or any of the end users that who work with MDCT. 

Our goal at Medable is to make clinical research accessible to everybody in the world, wherever they are located our North Star is to help deliver effective therapies to the people that want them or need them, as soon as possible. Clinical trials have had the Spotlight. Today more than ever before. And the world is eager to learn more and participate and we believe we can have an impact here in many ways. and by making medicine, accessible to patients via a decentralized platform that will allow them to enroll and engage with trials wherever they live in the world. We have a lot of work to do. But by collaborating with partners like many of you on this call. We firmly believe that medicine can be inclusive for all. Recently the Everest group analyzed the decentralized clinical trials industry, and 2021 was their first year doing that analysis based on their independent research. They ranked medical as the leader and number one in decentralized clinical trials. And one of the big reasons for that is that they cited us as the most experienced organization in the decentralized clinical trial space. To date we've done more than 150 trials, either decentralized or hybrid, we have more than a million patients who have interacted with our platform. More than 4000 sites have utilized our technology. And we today, operate across 60 countries, and 60 different languages.

The world changed dramatically in 2020. And we found that by working together and sharing the knowledge that we have as a, as a world, we can dramatically reduce the timelines to bring effective treatments to everyone, wherever they are. And so, that concept of how we as a world, work together to deliver the COVID vaccine. And kudos to all of you that had a part in that. We use that concept to inspire our global partner program, and the Medable Academy, which allows us, and is our message for sharing our best practices and recommendations from our deep experience in decentralized clinical trials with all of you. So together, we look at how can we transform clinical trials, using human centered trial design. So I've talked about, you know, a little bit so far, where we come into play right, we're the technology experts. 

We offer a full SaaS DCT platform. We're knowledgeable on how to integrate with systems across the place across the world, and connect all those different data points seamlessly. But you all are the leaders of Life Sciences. You are the ones thinking years ahead, you're experts in global regulatory and scientific knowledge. You are drug development experts, you have strategic development plans, months and years in advance and you're planning for that. And some of you have a desire to be able to be more and more independent, each and every day, to, to control your own destiny. And so depending on what it doesn't matter if you're there, or just starting, kind of, to explore that on your attorney, our academy program, and our offering, and provides you whatever you need on that. So, whether you want to continue to utilize an expert technology vendor to to leverage your expertise and collaborate together to configure a system to meet your exact needs, or be able to educate your team to do that, self sufficiently. 

We'd be happy to partner with you to do either. And ultimately we think by combining your expertise with our technology and our platform, together we can achieve better and more effective outcomes so designing workflows studies and solutions that are easy for patients to engage with help reduce the burden that they might have. The same applies for sites, reducing the friction for a site to be able to start up and site burden, And ultimately increase adoption, inclusion and retention in studies. As we drive forward and move forward in this new wave of of clinical trials and engagement with clinical trials, post COVID.

Ultimately, when we place a patient or a human at the center of a clinical trial, and we think about it that way and unlocks a major area of opportunity for all of us with technology and innovation. An example of how we do that is when we think about this, we think about what are all the different components all the different ways that data might be able to be collected or aggregated, that makes the life of anyone easier so whether that's a patient, whether that's a site, whether that's someone analyzing on the back end. And so here are a couple of different examples, whether it be patient services or home health immediate patient or they are connected sensors and wearables, so that anyone participating can collect that data in their day to day life rather than having to go out of their way to be able to answer that integrated with EDCs or direct to patient drug shipment, which is so important that sometimes you got to mention it twice. Ultimately, depending on what solution you have here what we do at medical is we proactively go out and assess and integrate these into our ecosystem. So I'll give you an example around connected sensors and wearables, we look at what are connected sensors and wearables that work for a variety of different demographics, across all the geographic regions that it might participate in and are regulatory approved, for example, so all of that work could be done upfront, which helps you stand up a study much faster than having to explore that on your own, as you're as you're designing your own protocol or your study. 

And the other key here is to use these types of technology partners, and this ecosystem in a way that leads to better outcomes rather than innovating for the sake of innovating. If you use a connected weight scale for example, that registers their weight. Each day, automatically and uploads it to a secure database that your site would be able to access in real time or get an alert if it's significantly different than the day before, that adds value. But if instead you add five or six different connected devices and sensors and wearables and there's additional training and the patient has to click 10 Different things for each of those three times a day, that adds burden, and it's more just innovation for the sake of innovation. So, ultimately our goal with this ecosystem is to make it as easy as possible for all of the stakeholders in this journey, other be an IT or software team, whether it be a sponsor or a CFO trying to select US or an end user that's ultimately trying to use any of these options to enter their data, or collect their data or participate in a trial, for example. 

Now, each of you may be at a different place in your organization's readiness to take on VCT. Some of you may say, we're 100% all in on VCT but we first have to educate all levels of our organization on key principles and approaches, and others of you may be thinking about trying to bring all DCT solution build or all technology build in house in the future. To reduce timelines control costs and improve efficiencies, or you could be somewhere in between on that spectrum or just looking to learn what the options are out there, what we have created through our Medable Academy is really an approach that meets you wherever you and your organization. Now walk through that here on the slide. So starting at the bottom where it says the foundational platform support any house that you build any staircase that you build you need a strong foundation for that, and similar that same concept for DCT what we offer here via our Medable Academy is training and knowledge and self service resources and a full program offered by role and persona, and I'll detail this some more in the next few slides that helps your organization understand really the basic building blocks of decentralized clinical trials. The beauty of this offering is that we actually made this Medable agnostic -  it would apply to any technology, any user that wants to learn more about these centralized clinical trials, or the technologies that could help them embrace that are supportive.

On top of that, and once you have that foundational knowledge, we offer different pathways for depending on where your organization wants to go, either now or in the future. So the first is the ability to design your own studies upskilling your team and learning the best practices for either creating new protocols that are created with DCT, or decentralized concepts in mind, and built for purpose with that solution in mind as well. The alternative is you can also use those same principles to take an existing protocol, and make sure that you can configure a solution with technology that best fits that protocol to help ensure the right outcomes are successful that you're looking for the next level of this would be allowing in helping your organization transform to bring some of the ability to actually configure and build out that solution in house yourself. 

So for example, taking in IE consent, and with drag and drop and point and click Tools, be able to load your own consent or deploy tele-visit to a study into your platform as well, are combining those two, and adding tele consent to your solution, creating questionnaires and notifications and alerts that would help to alert your patient, or the site to the information that they need. So putting the power of that in your hands, so that you don't have to go to an additional vendor, and to really streamline the process for when you'd want to put any of those changes in place, or be able to design that and keep in house. The best practices in the knowledge. As you progress through each chapter the process. The third level here on the right would be that autonomous vehicle type of example, right, working your way through the progression as an organization to get to a point where you might say, no, We want to be able to do this with little to no support at all we want to be able to do all this completely autonomously, and we want to fuel innovation within our organization, and use our own knowledge, and the studies that we've done in the best practices in the library that we've built to be able to become more efficient over time, or integrate with additional systems that we have, or whatever the case may be, to expand the reach of your organization, but again do that autonomy, again depending on where you're at either today or where you intend to go, we'd be happy to have more detailed conversations with you. 

But the key here is this is not a one size fits all solution, it's fit for wherever is the best fit for you or your organization today. In order to help your organization progress through those levels that I just shared, we've introduced certifications by role, via the Medable Academy that your organization would be able to go out and achieve today. All of these are available to them, and I'll walk you through each of these. So, the first on the far left is the digital foundation certification - I touched on this in the last one, same terminology applies, these are the best practice fundamentals that utilize the medical platform to deliver DCTs. 

Again, this is actually agnostic of Medable, so whether you're going down the Medable path, or looking at educate organization collectively about DCT, this solution will be great for you. The next is project management best practices that can be used. So, again, whether it be project management to make sure that you design and build it on time, to make sure that the protocol fits well within the technology or vice versa. That's what would match very well there. The third the digital architect is think about this in the same way that you build your house, so making sure that you sketch out everything in the way that you want it, making sure that you have the right supports in the right place, and that it's visually appealing and engaging and has all the different components that you want.


Our speakers

Jared Klingeisen is Senior Vice President of Partner DCT Enablement Strategy.