Simplifying Regionalization in Global Trials with Sam Clark, Senior Director of Vendor Management and Procurement at Clinical Ink, and Sudhir Reddy, Esper's CTO

[00:00:03] Hello, everybody, and welcome back to the Outcomes Rocket here on this TechRx series

[00:00:08] we're doing with Esper, your prescription for tomorrow's healthcare device challenges.

[00:00:14] We've had the opportunity to touch on navigating the healthcare device conundrum,

[00:00:19] talking about security, taking the guesswork out of the entire cycle of decision-making around DevOps.

[00:00:25] And today, we have the opportunity to host yet another very interesting episode on the topic,

[00:00:32] with me is the amazing Sam Clark. She is the Senior Director of Vendor Management

[00:00:38] and Procurement with Clinical Inc. Sam, such a pleasure to have you here,

[00:00:42] and thank you so much for joining us. Of course, thanks for having me. I appreciate it.

[00:00:47] Of course. And look, before we get into it, I'd love to just give you an opportunity to tell

[00:00:52] us a little bit more about you and also what Clinical Inc does.

[00:00:56] Sure. I am obviously the Senior Director of Vendor Management and Procurement at Clinical Inc.

[00:01:02] It's my favorite job I've ever had, so that's a good place to start. I have over a decade of

[00:01:06] supply chain experience, specifically focused on the crux of hardware and software working together.

[00:01:13] So this is a really great fit for me, and I'm excited to be able to share my passions

[00:01:17] with so many other colleagues. Clinical Inc is a clinical trial technology company.

[00:01:23] What we do is we bring data, technology, and patient-centric research together.

[00:01:28] Our goal really is to propel technology in clinical trials forward that allows for a better,

[00:01:34] more seamless, user-friendly experience, both for the clinical trial site itself and for the

[00:01:39] patients that are enrolled in the trial. And we have technology that allows us to do that through

[00:01:44] direct data capture, electronic clinical outcome assessments, telehealth, and we're really focused

[00:01:51] recently on moving into digital biomarkers and eSource solutions. So it's been a really fantastic

[00:01:56] growth period for us. That's really great, Sam. Thank you so much for telling us about you.

[00:02:02] It sounds like you're in your sweet spot, that cross-section between software and hardware

[00:02:06] in a high-impact role. So we're privileged to have you with us to contribute to this very

[00:02:11] important discussion. In addition to Sam, everyone listening and watching, we also have Sudhir Reddy

[00:02:18] with us. He's Esper's CTO, and if you guys remember, he was with us on Episode 3 where

[00:02:24] we discussed security and devices. Sudhir, welcome back. It's great to have you.

[00:02:29] Hey again, Saul. Great to be here. And Sam, great to see you again, talk to you again.

[00:02:35] Just for a brief history, Sam and I have known each other ever since we worked with Clinical

[00:02:40] Inc. for a few years now, really, and it's been a great journey with Clinical Inc., where they've

[00:02:46] taught us so much about what we need to do in the healthcare world, as well as we've hopefully

[00:02:51] solved their problems in a really cool way. So we'll talk about that.

[00:02:55] Yeah, for sure. And so Sudhir, thank you very much. It's really an opportunity now to dive

[00:03:00] into Clinical Inc. a little bit more. You guys are a global company doing medical studies, as

[00:03:04] you mentioned, in many countries, various languages in the world. How do you manage this type of

[00:03:11] complexity? The complexity, I think, of the business is often overlooked because it's very granular in

[00:03:17] nature. We are in over 50 countries right now. We have a variety of mobile devices that are

[00:03:23] deployed with a myriad of different language requirements. For a little background, when

[00:03:28] doing a clinical trial is the best practice and in some cases, a requirement to have

[00:03:33] the documentation in the patient or site's local language. So we have probably more than 50

[00:03:39] languages deployed also. To accommodate that, we really focus on building a process that's

[00:03:45] customized around each study need from the very beginning. And in this kind of specific instance,

[00:03:51] we also have to make sure that our operational processes align with that. So right now,

[00:03:55] we use a provisioning process that allows for us to customize the language at the order level.

[00:04:01] So we provision devices at each individual order level rather than for the entire study.

[00:04:07] And that allows the most flexibility. And then we have been fortunate to work with

[00:04:12] Esper to develop an automated provisioning process that allows for us to easily select

[00:04:17] that language, lock the language in on the device so that when it arrives to this site,

[00:04:22] there's no risk of anybody getting any incorrect languages.

[00:04:26] Wow, that's brilliant. And you know, in the clinical trial space, room for error is very small.

[00:04:32] So certainly great to know that you guys have this partnership that helps deliver on that.

[00:04:37] You mentioned software and devices. Let's talk about devices for a second.

[00:04:41] What role do devices play in your business?

[00:04:44] The devices have taken kind of a turn in our business. When I started here five years ago,

[00:04:49] we primarily used site-based devices. So things that you may see in a doctor's office or if

[00:04:55] you're visiting a clinician. But obviously with the COVID-19 pandemic, the desire for

[00:05:01] decentralized trials expanded very, very rapidly. And so we suddenly saw a huge influx of need for

[00:05:08] patient-based devices. And those tend to be mobile phones of some variety. The idea being it is a

[00:05:14] very critical component for patient adherence to the trial, but also you want to make it convenient.

[00:05:20] Something people can put in their pocket or their bag. Don't want them to be carrying around

[00:05:24] like a giant laptop-sized device. So we've really expanded heavily into mobile devices.

[00:05:30] Now, ClinicLink does allow and offer a service where patients can bring their own device,

[00:05:35] but we haven't found that to be as popular as we expected. And I think really are seeing a ton of

[00:05:41] growth kind of in that patient-facing device market right now.

[00:05:45] Interesting. Yeah. And I would imagine you would know, I would love to learn from you,

[00:05:49] Sam. It's probably more secure to have a device that's not brought by the patient.

[00:05:55] Yeah, it is. There's a lot of complexity around kind of making it user-friendly and secure at the

[00:06:01] same time, which is a sweet spot that we really want to be able to get to. Obviously, bring your

[00:06:06] own device model. There's always the concern that somebody may not be using proper security

[00:06:10] requirements on their phone. Maybe they're not using a PIN or it's not recognizing them and you

[00:06:14] have no control. It also makes it particularly challenging to support that device if something

[00:06:20] goes wrong. And that happens quite a bit. So we found a really third benefit there. So now we have

[00:06:28] a secure device that's easy to use, doesn't have too many buttons for folks who may get confused,

[00:06:33] but we're actually able to remotely access the device when it's enrolled in SBIRT, which allows

[00:06:38] our product support team to solve problems a lot easier for our patients. That's fantastic.

[00:06:43] I think this conversation for everybody listening today, it's super useful both from a device

[00:06:49] management and deployment perspective, but also for all our life sciences listeners. Thinking about

[00:06:54] the process and having partners like Clinical Inc., working with partners like SBIRT, it's about the

[00:07:00] ecosystem and how it all comes together. So I really love this, Sam. Okay, so let's get kind of

[00:07:06] rubber meets the road here. Once devices are in the field, security is an important part of this.

[00:07:11] How do you ensure devices are secure and locked down to a specific state?

[00:07:16] So essentially when the device leaves, it's almost in a kiosk mode, about I would say 98%

[00:07:21] of the way to complete kiosk mode. We do have some study specifications that preclude us from

[00:07:28] hitting the full, you cannot do anything on this device, but it's very close. Essentially, the only

[00:07:34] settings that we expose are Wi-Fi settings. So there is no other opportunity for anybody to be

[00:07:40] clicking around. We do also are able to use SBIRT to push application updates, and those do of course

[00:07:46] include security updates, which we do regularly. And we can guarantee adherence because we're able

[00:07:51] to see and track when something has been successfully updated, which is a really big

[00:07:56] challenge because once the device is in the field, you actually can't control when it's turned on.

[00:08:01] And that has been a hassle for our business in a lot of different ways. You will push an update,

[00:08:06] and then you have to wait until the user just happens to turn the device on. But with the

[00:08:11] reporting that's available in SBIRT, and the way that we can ensure updates have taken place,

[00:08:16] we're able to monitor that adherence throughout the lifetime of the trial.

[00:08:19] That's beautiful.

[00:08:20] If I could jump in here.

[00:08:21] Please, yes Sudhir.

[00:08:22] When we talked about the security and the compliance part in the previous episode,

[00:08:26] that's exactly what I was talking about, right? Where customers like Clinical Link need these

[00:08:31] highly detailed reports about what applications got deployed to the device, and when, and when

[00:08:37] the device came online and things. And that's the power of being able to report. And we also,

[00:08:42] I believe in the last few months, worked through with your compliance reporting needs

[00:08:46] and got the compliance audit through for various trials as well. So just wanted to throw that in.

[00:08:52] No, no, that's fantastic Sudhir. Thanks for saying it. And actually, that was a follow-up

[00:08:57] question that I had here is, how do you ensure device compliance? And, you know,

[00:09:01] even in that scenario where the device is off.

[00:09:03] I mean, if the device is off, obviously it is a little challenging. There is kind of minimal

[00:09:09] opportunities if the device is off, which isn't uncommon in your shipment model. Sometimes devices

[00:09:14] will remain on for several months before they need to be used depending on the specific circumstances.

[00:09:20] And I think we generally rely on our processes and our partnership with our customers as well.

[00:09:26] So ClinicLink doesn't always have a relationship or isn't always able to contact directly the

[00:09:30] patient that's using the device. So we really are able to leverage our processes with our partners,

[00:09:36] study team members and sites to ensure that folks are following those best practices.

[00:09:41] That's great to hear from the Clinical Inc side. And what about on the SBIR side, Sudhir?

[00:09:46] Share more about how that happens.

[00:09:48] Great question, Sol. And obviously when the phone is off or the device is off,

[00:09:53] you wait till the device comes on, which is the human process of going and getting it turned on.

[00:09:58] But what really the crux of the matter is, if the device is on at all, because if it's off,

[00:10:03] it's not a security threat per se. The moment it comes on, it becomes a security threat and you

[00:10:09] want it to be compliant and you want to have the latest application. That's where SBIR steps in.

[00:10:15] And we know when the device came on. We know exactly when it came on. And as soon as it comes on,

[00:10:21] anything new that needs to be pushed to the device, whether it's an application or a file or

[00:10:25] a security patch, whatever it is, it goes on the device immediately. If it couldn't do that,

[00:10:31] then somebody gets notified and they can take an action on that. So that's where it becomes key of

[00:10:37] as soon as it's on, the first thing it does is it gets updated to what the latest is that it needs

[00:10:41] to be on. The analogy that comes to my mind, and you guys could gut check this, is like I bought

[00:10:47] a Ring doorbell and out of the box, I connected it to Wi-Fi and then it said,

[00:10:53] all right, we've got some updates for you. And then all of a sudden the updates got installed

[00:10:57] and then boom, just hooked it up. Is that similar? Yeah, it's pretty similar.

[00:11:03] Love it. Outside of the healthcare industry, that is one of the use cases we solve as well.

[00:11:08] Is home automation equipment. You bring it home, turn it on and plug it into Wi-Fi

[00:11:14] and you're off you go. I love it. As a consumer, and we are bringing this consumer experience in

[00:11:21] the healthcare more, these experiences are starting to merge. And it's really great to

[00:11:26] be here with both of you, bringing those consumer-like experiences, making them a reality,

[00:11:30] making them turn key for a really important field, which is clinical trials. So really exciting.

[00:11:36] We love covering forefront of healthcare and the future and you guys are it. This next one's for

[00:11:41] both of you, Esper and Clinical Inc. You guys have been working for some time from what it

[00:11:46] sounds like. Have you had to overcome any obstacles in your relationship? Yeah, I think we have. I

[00:11:52] think with any relationship, there's always going to be challenges. Our business relationship started

[00:11:58] just as the pandemic kicked off. So I think that was kind of our first big challenge to get through

[00:12:04] together. And we've spent time this last year, as Sudhir mentioned, really working through our

[00:12:09] compliance process, finding ways to develop solutions and root cause analyses that meet

[00:12:14] the requirements, not just of Clinical Inc., but also of our customers. And we were able to really

[00:12:19] work through those challenges, I think very collaboratively. And I know we learned a lot in

[00:12:23] that experience as well. And so much so that we've been able to actually take some of those

[00:12:28] processes and learnings and build them larger into our vendor platform. So we've changed some of our,

[00:12:34] in my own kind of review processes and documentation based on that experience

[00:12:38] that we had with Esper. So it is never easy when you're working in a highly regulated industry

[00:12:44] and a time of hyper growth in the middle of a pandemic. But I do think that it certainly has

[00:12:49] made Clinical Inc. a better partner, and I think it's pushed us to a better place. So all in all,

[00:12:55] all is well that ends well, I guess. Thanks for the kind words, Sam. And likewise, right?

[00:13:00] Every relationship has moments of learning that we learn and where we improve. A specific example

[00:13:06] is the language feature that Sam talked about earlier. We did not have that feature. We didn't

[00:13:11] know that that was as important to the clinical trial space. And working with Clinical Inc.,

[00:13:16] we learned that that is important, and we went ahead and implemented that into the product.

[00:13:20] And now everybody can take, has the benefit of using that. It's that kind of partnership with

[00:13:25] our customers like Clinical Inc. that we really value. And from our side, we want to bring

[00:13:30] partnership to the table every single time. So if there's a need that's unsatisfied, we'll figure

[00:13:35] out a way to work through it. And we'll figure out a way to help with that because that's how we

[00:13:40] become that cutting edge. And Clinical Inc. is on the cutting edge of what they do. We're on the

[00:13:44] cutting edge of what we do and together we grow. Yeah, I love that. Oh, were you going to say

[00:13:49] something, Sam? It's just been really fun. I think too, there is a specific example where we were

[00:13:54] working on a really large study that had very specific requirements that we were not accustomed

[00:13:59] to. And we were able to have several folks from the Asper team actually come in and serve as our

[00:14:04] backup to help us provision devices and kind of troubleshoot on the ground. So it's been a really

[00:14:09] exciting journey for me to be able to see that from the very beginning stage to seeing it essentially

[00:14:14] work seamlessly. Now, it's quite nice. Yeah. And Sam, you mentioned the trifecta, right? You're

[00:14:21] in hyper growth mode, COVID's there, new requirements. And it's these pressure points

[00:14:26] that make diamonds as they say. And I'm seeing here, you know, I didn't get the chance to and

[00:14:30] the listeners and viewers didn't get the chance to see you guys in action. But we get to see

[00:14:35] the end result, which is two great companies, adding tons of value to really consumers and

[00:14:42] healthcare providers and life sciences. What does the future look like for this partnership?

[00:14:47] I think it's a good future. We are hoping to kind of continue to work with Asper to find new ways to

[00:14:52] streamline our provisioning process, continue to deliver on requirements that change kind of as

[00:14:58] our business expands, we find different ways of requiring things, particularly connected devices,

[00:15:05] is going to be an exciting new foray for clinical link. We've been in the connected devices field

[00:15:10] before, but we're really heading into it much more broadly. And I think that will be a wonderful

[00:15:16] challenge for us to work through together, making sure that we can develop a process that allows

[00:15:20] our consumers to use the full platform, so to speak. So I think that's where we're headed. Of

[00:15:24] course, in clinical link style, we like to do things with zero errors and at the fastest pace

[00:15:29] possible. So we'll be prepared for that next. Love that. Very high standard. Sudhir, any comments

[00:15:36] from you on that one? Yeah, from our perspective, it's the same continue the partnership with

[00:15:40] clinical link, not only with new studies that they have to go and serve and Sam talked about

[00:15:45] the zero errors and helping them get there. But in addition, looking at where strategically we can

[00:15:51] together take this technology that we're building, right? So we've been talking about collaborating

[00:15:56] on more ways to automate the entire process from the devices leaving the factory all the way to

[00:16:02] the devices reaching the patients or caregivers and how that whole process can be automated so

[00:16:07] that you don't have to then provision things in a factory or in a warehouse somewhere before you

[00:16:12] send it off to patients and things. So we're thinking about these strategic ways that we can

[00:16:17] improve the automation for cutting edge clinical trials and remove a lot of the redundancy or

[00:16:23] the latencies in the system. Thank you, Sudhir. It's about today, but also about where we're going in

[00:16:30] the future and sort of taking a look at the horizon and the possible challenges and things

[00:16:35] like that. Really appreciate today's topic as we close this series. And look, I just want to open

[00:16:42] up the mic one more time for you guys. Any closing thoughts for our listeners and viewers today

[00:16:46] before we conclude? I mean, I think from my perspective, I'm just happy to be here. I'm happy

[00:16:50] to have seen this kind of idea come from infancy to where it is now. And I'm really excited to see

[00:16:57] what happens in the industry and also what happens with this business relationship,

[00:17:02] hopefully in the next five years. Thank you, Sam. Thanks, Sam, for the great partnership. And

[00:17:08] we'll continue this partnership. I'll do my shameless plug, go to the Esper.io website and

[00:17:14] look at the blogs. I have a series on the vision for DevOps for devices. Three of those are out.

[00:17:20] There's more to come on that series. So please go check it out. And Saul, I want those diamonds we

[00:17:25] talked about. Let's go find those diamonds. Oh man. Hey guys and gals on that page. We'll link

[00:17:31] it up here. All the show notes are going to be in there. So we'll have links to Clinical Inc, Esper,

[00:17:37] and of course Sudhir's blog, where you will find the diamonds

[00:17:44] for your organization. Thank you all for tuning in.

[00:17:48] Sam Sudhir, thanks for being with us today. This has been a pleasure.

[00:17:51] Thank you.

[00:17:51] Our pleasure.