Episode Transcript
[00:00:03] Speaker A: Welcome to Power to The Patients, a LinkedIn Live and podcast series hosted by Power, where clinical research leaders across sponsors sites, CROs and patient advocacy groups discuss patient centricity in clinical trials. We explore the bottlenecks in today's system, challenge the status quo and talk about future opportunities for innovation.
Let's dive in.
[00:00:31] Speaker B: Really excited to be having this conversation today. Jessica. Thank you so much for spending your time with us. For those listening, Jessica is the CEO and founder of a few really amazing companies, ClinCloud and MyMemory Clinic, both serving folks in the near psych space. So really excited here to be having this conversation. Just learning as much from Jessica as possible. Jessica, welcome to the show.
[00:00:49] Speaker C: Thank you so much. I'm thrilled to be here.
[00:00:51] Speaker B: For those who are less familiar with the kind of the journey you've been on, maybe just give us a high level sketch of your journey through, you know, kind of like the front lines of doing research as a coordinator through to being the now founder CEO of two kind of businesses in the space and board members and a few others.
[00:01:07] Speaker C: Too much like many in the research arena, you stumble upon the career. It wasn't something that I was seeking. It was just kind of a byproduct of me taking a gap year between college and med school. And that was the best gap year of my life. I mean I really discovered something that I had no idea even existed as a potential industry to apply my skillsets and my love for science and public health. So really from there I was on the boots, on the ground doing data entry, clinical research coordinator, basically performed every single role in about three years. And I had a fantastic mentor as well. And he's the one that kind of said you could go out and do this on your own if you wanted to. And at the time I think I was probably 24, 25 and I was like, that's kind of scary, but I mean, when else am I going to do it? So I decided I'll go ahead and start ClinCloud. And ClinCloud really came about because we really wanted to bring new technologies into the clinical research space. So when I first opened up, everybody was still doing pen and paper or pencil and paper. And it was very archaic. We had a lot of binders, it was very.
So I started my clinic fully remote or capabilities being fully remote. So we had e source, e regulatory. We even created an app to help facilitate with conducting memory screens in the comforts of individuals homes so that we could make it easier for people to come and participate in Clinical research. Fast forward probably three, four years down the line. Another key area that we really started to pay attention to was a lot of these patients who are coming to us because they want to know if they're at risk for Alzheimer's disease or Parkinson's or whatever it might be. We're kind of the first people that are diagnosing them, and they don't have a provider that they can then go back to that is specializing in, say, dementia or something like that. So that's when I kind of said, all right, well, it'd be a good idea for us to open up my Memory Clinic so that we can create an ecosystem for these patients so that their dementia care, along with their clinical trial care, can all live with one ecosystem. And my Memory clinic is a telehealth company that services patients who are in the early stages, even the later stages of Alzheimer's disease. But again, fully remote. You can do it from the comforts of your home. There's no brick and mortar, and it just allows for accessibility and access to care, you know, tenfold, to what typically we see.
[00:03:52] Speaker B: Totally. So six years ago, you kind of mustered the courage to go do this. I'm just, I'm curious, one founder to another. Right? Like, that must have been quite the jump.
[00:04:02] Speaker C: It was. But what I will say is, as long as you have hard work and passion for what you love to do, it's never going to be easy. You're going to work 10 to 15 hour days, seven days a week, and, you know, as long as you put the time in it and build something from the ground up that you're truly passionate about, the team members that you bring on alongside you, they're going to see that passion and they're going to mirror that passion throughout the organization.
[00:04:29] Speaker B: Yeah.
I think one thing that's really amazing is you had this kind of vision almost for, let's call it decentralized remote seven years ago. How did you know? How did you know?
[00:04:42] Speaker C: Intuition, I guess. But it was quite funny because I was at Dia in 2019 and I met this company and they were called SNAP Iot. And I was just completely enthralled by their capabilities because it was something different from your typical ECOA that you see with the phone systems embedded within a clinical trial. They really had the capabilities to utilize it on a recruitment arm, if you will. So I said, I pitched them the idea, what if we go ahead and do virtual pre screening so that before people come in and get an in person pre screening with us, we can do it virtually. And we were doing the MOCA virtually. We were collecting medical history, they were assigning econsent. And honestly that saved us. When 2020 hit, we were still able to recruit patients and it actually allowed for us to mobilize some of our clinical trials that we had. We worked with sponsors and they allowed for us to utilize that app to continue collecting information from patients because they weren't able to come into our clinic.
[00:05:48] Speaker B: Yeah. And fast forward for us now. You started with a fully kind of remote service today. Where are you? Tell me a little bit more about like the kind of like full suite of capabilities you have now when you work with.
[00:06:00] Speaker C: Sure. So one thing I want to clarify though is our clinical research site at ClinCloud was never decentralized. We just wanted to have the capabilities to be paperless, if you will, so that people could monitor remotely and what have you. So right now ClinCloud has two locations, one in Maitland and one in Viera. We specialize in neuroscience as well as gastrointestinal and we are multi therapeutic, so we'll throw in a few from there. But we've actually expanded and we now have a partnership with Tandem Clinical Research, which has allowed for us to expand to Louisiana, New York and New Jersey. And now we're creating central departments across all of our sites for EDC recruitment, regulatory, so we can be as efficient as we possibly can across all 14 of our centers.
[00:06:54] Speaker B: Yeah. And then in that partnership, are you primarily acting as kind of like a technology backend to kind of partner with Tandem sites? Like, how is that working for you?
[00:07:03] Speaker C: So I wouldn't say that we're on the backend. We all use the same technology platforms, if you will. So we're all in creo, we're all in complyon. We're really trying to leverage, you know, new recruitment initiatives that are powered by certain AI technologies, if you will. But we basically serve as the Florida department for all of the sites within Florida. And then Tandem has the sites in Louisiana, New York and New Jersey.
[00:07:29] Speaker B: Yeah, we love the theme at Tandem as well.
[00:07:31] Speaker C: Yeah. So we're still sites. We just, we. I like to think we pioneered some of the technology innovation.
[00:07:38] Speaker B: Totally. Yeah. I mean, you're ahead of the curve.
Tell me, what are some of the real challenges you see on the ground in terms of using technology in the way that you're doing and that in particular maybe in working with some of these patient populations in neuroscience.
[00:07:56] Speaker C: So there's definitely challenges, especially if you are trying to go into rural areas where WI fi is you know, probably a little bit more spotty in certain situations like that. So one of the things that we've really tried to do is build partnerships when going into these rural communities so that we can have a hub, if you will, of where individuals can go and have some of these virtual assessments completed. So we advertise, and then we advertise, come to this center so you can have your virtual pre screen completed. So that's one area that we've really tried to hone in and fix. Because obviously, if you don't have good wifi, you can't get on with some of these technologies. And honestly, you can't even gain a greater understanding of what clinical research is in certain capacities. So tied to that, we also do a lot of boots on the ground education and awareness in communities like this for populations that, you know, where individuals have the early stages of memory loss. One thing I always tell everybody is the number one thing people don't want to hear is my lack of independence. So even though individuals who are in the earlier stages of having memory concerns, they still know how to open a computer up. They still want to open up the computer up. They still want to have their appointment the way that they envision wanting to have that appointment. Where things get a little bit more challenging is when individuals are progressing into the moderate to severe stages of Alzheimer's disease. And in which case you got to make sure, just like we typically do, you have to have a care partner or a friend or family member who can accompany you during these visits or during these appointments. So that's how we've kind of been working through that additionally, you know, in person, right. You have the option to do this in a virtual capacity, or you have the option to do this at our clinic, whichever one you prefer. So we put a lot of accommodations in there.
[00:09:54] Speaker B: So I'm kind of dying to know. I've never built a site from the ground. If you were to build a site from the ground up, again, how would you go about doing it? What are the kind of steps to get to a place where you can successfully be running these neuroscience trials?
[00:10:12] Speaker C: For me, it took one study, one study with a great sponsor, and that allowed for me to get some cash flow in relatively quickly, which is always important. Right. Whenever you're starting out, you need to make sure revenue is coming in. So we got a really great contract, and you just need that one. And then you got to crush that one study. You can't do bad at it, right? So you really need to make sure that you're staying super focused. You know where the patient population is so that you can get them into the study. You've got a good team around you to make sure that you're doing a great job with data entry and getting the patient through the clinical trial journey as quickly as you can and as safely as you can. And really that's what you need to kind of get yourself started. It seems so small, but it's a lot of work to get that one sponsor to say, yes, I trust that you brand new company are going to be successful in it. So in preparation for that, you got to make sure you know where your patient population is. You gotta make sure you've started to vet out those patients to make sure that they're gonna preliminarily qualify for this study and then get your site in order. Right. They're the bare minimums that you need. So you need your negative 80, negative 20 freezer or refrigerator if you're doing, you know, refrigerated IP, whatever it might be. So just make sure you've got the bones of it together. If I were to do it again differently, I've thought about the idea of actually going inside, embedding myself within a provider practice to get started, and then starting to kind of grow organically around that patient's population inside that practice, because I went completely independent outside of a provider practice.
[00:12:00] Speaker B: What are the kind of maybe special accommodations or strategies you need to have in mind if you're going to be working in neuroscience?
[00:12:07] Speaker C: In neuroscience, you really need to make sure that your team members, or a few of your team members in particular, have background either in mental health, counseling, social work, or an elevated degree so that they can do a lot of the psychometric scales. A lot of those individuals performing those scale assessments need to be blinded, which means if you're the study coordinator, you can't also be the one doing scales a lot of the time. So we have to reserve.
The other element is making sure you have an unblinded and potentially blinded pharmacist as well. They can serve as RNs, at least in the state of Florida and throughout most of the country, as long as you have an MD or a PharmD that's overseeing them in particular. But those, I would say, are the two biggest hurdles. And then making sure your principal investigator either has experience in the neuroscience as an investigator, or has clinical experience treating these individuals.
[00:13:06] Speaker B: Gotcha. And one of the things that you mentioned earlier was not wanting to touch on this idea of lack of independence or that that might be Kind of like a sore spot. What are the other things you've learned about serving the patients outside of kind of like the operations of the site?
[00:13:22] Speaker C: The number one thing that, especially when we first started with Clincloud, it began with being purely a dementia clinic. We were just focused on that. And what a lot of people want to know is, where am I at baseline wise? So it's always really important that if you're starting a site, especially in the. In the memory or neuroscience realm of things, if you're able to offer complementary memory assessments with patients or complementary depression scales with patients, a lot of people just want to know. And a lot of the times when you're in those earlier stages of the condition or the disease at large, you don't want to necessarily book an appointment with a doctor, go get an assessment done, then go see a specialist. And a lot of the times in the dementia world, getting in to see a memory disorder specialist or a neurologist can take anywhere from six to ten months, I've heard, and a lot can change right during those timeframes. So offering a complimentary assessment, reviewing and educating patients on the outcomes of that assessment and what resources are available is probably the number one most important thing that you can do. Always treat it as education. Don't push clinical trials. Clinical trials is going to come as a. As a byproduct of the individual's assessment at large. So that, I think, is the number one biggest thing to be very mindful of. And then if somebody does qualify or matches with a clinical trial that you have, it's important that you're educating them during that initial appointment with them on what the benefits are and what the risks are. It's important to note you need to come with a study partner. You have to come here with somebody, especially if that's the trial that that requires. And one of the other things that we recommended are kind of built into our practice as well, is we notified that, hey, this is a journey that, you know, might end after you start getting some of these diagnostics or scale assessments done. We might determine it's not Alzheimer's disease, but if it is Alzheimer's disease. We also offered mental health counseling to the individual that was newly diagnosed, as well as their caregiver, too, because again, to my comment previously, a lot of the times people came to us without a diagnosis and we were the ones diagnosing them. So we built that into our clinic so that we could help service patients in that capacity as well.
[00:15:52] Speaker B: Maybe an invasive question, but how do you make the kind of costs tie with doing all this work in a complementary way. How do you think economics of that?
[00:16:01] Speaker C: You got to make sure to negotiate your budgeting contract really well. So a lot of what we've done is we've negotiated the pre screening activities into our budgeting contract. So we get paid X amount for every pre screen that we complete. And then I've also baked in a retention line item into our clinical trials as well. For the ones that it makes sense where we're offering these mental health counseling services or say it's a third party retention service that we're working with and you won't get every single one, but the ones that you do get, it kind of does help at least offset some of the other costs.
[00:16:39] Speaker B: What are your non negotiables? Like if you're like a sponsor's coming to you with a study and you're like, hey, these are the few things that I absolutely need in this study for me to take it. What are some of the things?
[00:16:48] Speaker C: So in terms of budget or budget study design?
[00:16:52] Speaker B: All the above.
[00:16:53] Speaker C: So for me, I mean like I'll keep it easy based on my psych capabilities, right. We don't have a phase one wing, so I'm not going to do any phase one studies if it requires overnight stays or anything like that. So no, I'm not going to do that. If it's an indication that we don't have the patient population for, I'm going to decline it because I want to be successful in my recruiting capabilities. Now keep in mind though that I'm going to leverage the relationships that I have in my community and my physician referrals before I say no. Because if I have Dr. So and so who's a dermatologist and I have an atopic dermatitis study that's just come through, I might be able to source those patients, you know, in that capacity in terms of, you know, budget and contract, I'm always going to make sure that there's a study startup fee that's involved. I'm always going to push to have my pre screens reimbursed to some sort of capacity.
I'm going to make sure that we have a recruitment line item, but the recruitment line item sometimes you got to get a little bit creative with because sometimes they'll only say this is my flat fee. Well, if you do good work, you can kind of do a little bit more of a risk sharing model with them where you know, I've done sometimes I want the cost of a randomization Once I enroll people into the study, whatever it might be, you know, just keep that in mind. And then I always want to make sure that we have line items in place to help cover our costs for our technologies. Right. Because again, we pay for a ctms, we pay for e regulatory. So we want to make sure that those costs are also getting paid for through, through this study in particular. So those are just some of the few things I'm sure that there's a bunch more I could rattle off. But I know their sponsors probably listening to this. So yes, I'll take all of your studies.
[00:18:48] Speaker B: You're one of the early adopters of some of this technology. What are you most excited to see coming down the pipeline, technology wise?
[00:18:55] Speaker C: What I'm the most excited to see is there are some really great technologies that are able to embed inside of EMR systems and actually retrieve the medical records that can then be put pushed into your CTMs. So if I have a patient who comes to me naive, I don't know any of their medical information, they can sign a release and we can send it out and it'll gather from all of their providers, all of their medical records and put it into one reservoir. And then there are technologies that can then actually comb through the medical records and help identify who might be a good candidate for your specific clinical trials. So those I would say are my two favorite new technologies that are coming through the pipe.
[00:19:42] Speaker B: Tell me a little bit more about why this EMR capability is so important to you.
[00:19:46] Speaker C: Well, it's because it's a safety thing, right? I mean, number one, we don't ever want somebody to enter into a clinical study if they're not healthy enough and it's not safe enough for them to do so. I mean, there's some individuals that really, you know, don't want us to have any of their medical record information and we have to take a really hard look on, well, is this patient going to be okay enough to actually pursue this? Getting those medical records just really allow for us to have the full picture and full understanding of the patient's well being and, you know, medical background so that we can make an informed decision that yes, it's appropriate for you to move forward with this clinical study and then also continue to have those medical records sent over to us. So not only on the forefront, but I want to be able to get those medical records as you're seeing your doctor because I want to know, was there a prescription change that took place that maybe you didn't report to us and why did that happen? Was it because an adverse event? Right. You know, we figured that out patient not too long ago, they started on a migraine medication and this patient was in one of our dementia studies. Well, having migraines or headaches could be a potential sign of aria. But if you're not reporting the migraines or the headaches to the clinical research site, we can't do our due diligence with sending you to go get that brain MRI done to see, you know, if any ARIA is present. So having that information come through from your doctors too, just allows for both systems to talk cohesively, if you will, with each other.
[00:21:24] Speaker B: How did you ever do this before?
[00:21:25] Speaker C: I would partner with a lot of providers and when individuals would come into our clinic, they signed a medical release form and essentially we just had to over communicate with the patients. When is your next doctor appointment coming up for your pcp? You know, reminder, please have them send us, you know, the most updated medical records or we would find out afterwards and then have to fax to obtain those medical records. So it was a very manual process, and it still is manual, but we have some relationships with providers that allow for us to gain that access that's a lot easier for us to maintain.
[00:22:07] Speaker B: Kind of touching on one of the topics I know that you think a lot about, which is patient recruitment. What does it take to be best in class as a site at patient recruitment?
[00:22:17] Speaker C: Well, number one, I tell everybody you can't just put all your as in one basket. You can't rely solely on social media advertisement, which some people might disagree with that I really am a huge proponent of. You need four approaches. You always will need digital campaigns, whether that's through Facebook, Instagram, Google, AdWords. That to me is more of your branding capability and your large funnel. Just the best way you can maximize the number of people or number of individuals, your audience, if you will.
The next is community outreach. Community outreach in the sense of that's very targeted. So who are your community partners? What patient populations are you really trying to engage and make sure that they're aware of? And then your messaging needs to align with what are clinical trials or take it back even further. What's the indication or the therapeutic area that you're trying to recruit individuals for? Do we just need to go and talk about, you know, what is dementia or what is fatty liver disease and really give education from that background? The third, and to me is probably one of the most important, are your provider referrals. So I think it's really important that you have strong relationships, doesn't need to be with everybody in your community, but strong relationships with providers that are able to, number one, give you access to their EMR system so that you can have somebody assigned and helping kind of be the champion of that practice to pre identify candidates for your clinical research studies and really again, make it a, a two way communication. So those providers really need to make sure that they're also talking and introducing clinical research to their patient population. If they're not doing that, the relationship's not going to be successful. And then the fourth is your patient database. There's so many people that have come through from your Facebook advertisements, from your community events, even from your provider relationships that are all funneled into your patient database. Just because six months ago you didn't have that acid reflux study doesn't mean that somebody in your database doesn't have acid reflux. So you're going to want to make sure you're constantly querying your patient database and trying to engage with them through text blasts, email blasts, whatever it might be to notify them of this new study opportunity.
[00:24:49] Speaker B: I'd love to just like step through each of these in a little more detail. So let's imagine that we're doing a, a depression study together and we're doing I'm coming to you and I'm like, hey, let's do this depression study. I'd love to see how you're going to do all four. The first one is digital campaigns. As a site. How do you think about approaching digital? How do you think about the capabilities required and the amount of budget you need in order to really knock that out of the park?
[00:25:12] Speaker C: Yeah. So budget is always going to depend on your location. Right. So if you're in a region of the states, let's say, where there's a lot of clinical research activity in the center, your budget for digital advertising needs to probably be double what somebody in another location of the US is. It's because you're competing against other people doing the same type of advertising. The other thing which is the most important is really the messaging piece of all of it. You don't just want to have a digital ad campaign that's out there saying, do you have Depression? If you're 18 and older, click here to get paid. That doesn't resonate.
It resonates with some, but almost you're attracting the wrong group of people into your clinical trials by doing that. So you really need to identify what's the emotional heartstring of depression. For instance, so what are some of the symptoms that individuals are experiencing? Are you feeling secluded? Do you not want to go out and hang out with your friends anymore?
Have you just going through things like that where you're actually building a rapport with the, the patient population, the audience that you're really trying to connect into. That's the type of messaging that you really want to engage with. And then from there I suggest that it's not necessarily just going directly into a study, but let's bring you in for that prescreen visit. Let's do a baseline depression assessment with you. Let's then discuss the options that are available. That way people don't feel like they're just doing it to be funneled through a clinical research study, because that's not what it's about. Clinical research is really meant to be a part of your continuity of care.
[00:26:57] Speaker B: And I can see how this starting point with the assessment is so critical. I'm sure you talk to other leaders at sites. How common is it that other sites are doing this kind of baselining assessment complex?
[00:27:11] Speaker C: It's become a lot more popular than it was, I would say six, seven years ago. One thing that I am noticing as a trend, and we're actually doing it a little bit too, is more self guided assessments that you can tag on from digital side of things. So for instance, instead of the patient coming into our clinic to have that baseline assessment done after they've clicked on the digital ad campaign saying that oh, I'm interested, then it takes them to a landing page that has a series of questions regarding their depression or maybe it's an assessment that they will be able to self guide and do. And then after that then they have the ability to then schedule a telehealth appointment or a phone call with a representative from the site to go over results or discuss next steps at that point. So I think that's a way that sites can actually elevate once again their access and pull from somebody being out there in the digital world coming in for an actual screening visit for a specific study.
[00:28:16] Speaker B: That makes so much sense. Let's move on to part two, Community outreach. What does it look like to really.
[00:28:21] Speaker C: So you've got to have a really good team behind you. I always say your All Star is 9 times out of 10 going to be one of your investigators who loves to educate and talk to the and talk to patients in particular because the draw of why people come to these educational seminars is the name, right? If you have an MD behind your name, you're going to get more people that are coming in to attend than anything else. You also want to make sure that your topics are relevant and they're not necessarily overused in your certain regions, too. So, for instance, our community outreach team has really been looking at new ways to engage the community. So they're doing like a painting with a twist.
Come, you know, come utilize your brain health and come painting, you know, with us. And then the topic of conversation is how, you know, creative outlets is important for brain health and development. And then it leads into, you know, early signs of memory loss and the importance of getting a baseline memory assessment done, for instance. And then other ways are identifying areas throughout your communities that also represent diversity. So whenever you're going into communities like this, number one, you always want to make sure you're representing yourself to that population that's culturally respectful as well. So that's always really important. You know, if I go in and it's not somebody that I look like, the ability to connect with them is. Is off a little bit. So you want to make sure you've got diversity within your community outreach team so that you can connect to all groups of individuals. So that's always really important, too. I know I kind of went off on a tangent there, but I think I covered most of it.
[00:30:06] Speaker B: No, I like. And I want to dig in more. Okay, so it sounds like the way that you're approaching community outreach is you've got members of your team and you're hosting almost talks or activities or get togethers that are related to the kind of indication of focus area here. I'm a PI and I'm working for you, Jessica. And I'm so busy. Like, how many of these do I need to do?
[00:30:27] Speaker C: I'd like to do at least four educational events every month. If you do more than that, it kind of gets a little overused unless you've got, you know, a huge geographic area that you're really trying to pull. So I typically say four seminars a month, and then I usually say four activities or health fair, like situations where maybe it doesn't require an investigator, but we have some sort of representation at a health fair, or maybe we're representing at a bingo at a local church, you know, that they're doing. So we can help educate from that capacity.
So four with an investigator and then four not without an investigator.
[00:31:11] Speaker B: Gotcha. Is it always the same investigator who goes.
[00:31:13] Speaker C: We know who is comfortable in the community and who is not comfortable in the community. So we really rely. We've got three people in Florida in particular, that they kind of do round robin whenever we need any sort of events. And then we did hire on an individual. She's our medical science liaison. She's not an investigator with us, but she does have her medical degree. So utilizing her, she's a great presenter. This is another individual that we tend to lean on.
[00:31:49] Speaker B: Talking about the venues. Right. Like, setting up a brain painting event is a pretty different thing than maybe going to bingo and participating in bingo. Like, how do you even identify?
[00:32:03] Speaker C: My community outreach team is just amazing. So they network like crazy and they're always trying to do something different than what somebody else in the community is. So a lot of the times they will actually go to vendors, for instance, that are doing painting with a twist or pottery or whatever it might be and say, how much would it cost for me to host an event here for 30 people? You know, and then that's how we go through that.
[00:32:32] Speaker B: Gotcha. And they've got like a calendar there, just.
[00:32:34] Speaker C: Yep, exactly. Which is virtual, not on paper.
[00:32:40] Speaker B: E calendar, of course. Provider referrals. Okay. The third one was provider referrals. Talk to me about that. What does it take to do?
[00:32:45] Speaker C: It takes a long time. So the provider referrals is a long term game for everybody. It's definitely not short term unless you get really lucky, you know, and you've got a practice that wants to sign up with you. So the way that we have everything kind of developed is these individuals are not serving as investigators with us on our clinical research studies. The provider referrals are truly just that. They're referring patients to us for participation in the clinical research study. It can take multiple times, meeting with the practice multiple times, trying to identify who the champion of that practice is in order for you to be successful. A few things that we evaluate before we engage with the practice though, is, number one, are they independent or are they linked to a healthcare organization? Typically, if they're an independent provider, it's a little bit easier for you to establish a relationship rather than being a part of like a network. Although I've done it, it just takes longer if you're trying to get into like a healthcare network. The next is, what does their patient population actually look like? So are they a pcp, are they a neurologist, are they a gastroenterologist?
And just trying to probe like, how many patients they actually are seeing on a day to day, a week to week, month to month. And then always ask them the question, how many new patients do you typically see? And then the next thing that I Always focus on again is more of that support staff. So do you have an office administrator? Is it the same office administrator that you've had for the last five years, or have you had six different office administrators within the last six years? Because that can be really hard to establish a relationship if your point of contact is always changing. So those are just some key things when you're going into those relationships to be super mindful of. But then once you get to that point of establishing a relationship, you do have to make sure legally everybody is squared away. So the provider and you have to sign a baa.
We put together a scope of work that outlines their roles versus our roles. And then from there we assign what's called a clinical research liaison to the practice and we're supposed to serve as the research specialist, if you will. So just like a provider refers you to a cardiologist, the whole process of you referring them to ClinCloud as your research specialists, that's the goal of everything. And then the narrative with that is we have our clinical research liaison help facilitate in doing chart reviews, whether that's through AI technology, whether that's manual or whether that's a fax referral that comes over to us. Our team is responsible for reviewing the information and then communicating back to the practice who qualifies for our various clinical research studies at that point in time. And then that prompts the provider to introduce it to the patient. And then all the provider has to do though, is say, you look like you might be a good candidate for this acid reflux study. I'm going to refer you over to ClinCloud, our research specialist, to name of the clinical research liaison who's going to take it from here, educate you on everything. And then after that we provide reports. Right. Because again, it's all about continuity of care. So the provider is aware when the patient screened, when they screen failed, when they enrolled into the study, when they completed this study, we built things on the back end too. So there's two way communication that's HIPAA compliant. So if the provider wants to know, where's Sally Su in this clinical research study, they have a HIPAA compliant portal that they can go into and see, has Sally sue screened for this Alzheimer's disease study yet or not?
[00:36:44] Speaker B: Gotcha. So you've got a clinical research liaison staffed to every provider that you're partnering with who's literally doing chart review of some form, whether AI assisted or manual, lagging patients that kind of come in at the site. And these liaisons sit in the office with you? Do they sit in the office with the provider? How do you manage that?
[00:37:04] Speaker C: It kind of depends. So if we have web based access, we don't need to go into the practice. If we don't have web based access and they're requiring us to be on site to do the chart reviews and contact the patients, then we'll schedule a day either out of the week or maybe out of the month. Just depends on how much volume is actually coming from that practice.
[00:37:24] Speaker B: That's incredible. How many providers or sites does a liaison cover?
[00:37:29] Speaker C: Typically between 5 and 6 is what I look at. Similar to like a study coordinator, you know, on the number of studies per study coordinator. There's a lot that goes into it from the reporting and those individuals are also responsible for calling all those patients and following up with them, scheduling meetings with the providers once a month. So there's a lot of work that goes into it.
[00:37:51] Speaker B: What are their metrics? Like how many qualified referrals do they identify every month and how many do you expect to kind of materialize on site for a screening visit?
[00:38:01] Speaker C: We typically, it'll be a lower number that we get of like qualified people per month from a provider, if you will. However, the conversion from somebody being identified to randomizing, we're seeing about 35 to 40% of those individuals coming from a provider, which is what we would anticipate.
[00:38:22] Speaker B: Sorry, 35% of your randomizations come from a provider referral.
[00:38:26] Speaker C: 35 to 40%. And for those neuro based studies it's even higher, to be honest with you Brandon, because it's a harder condition for people. So we probably sit closer to 50 to 60% coming from provider referrals, I guess.
[00:38:41] Speaker B: How do you think about systematically building your list of provider referrals? Do you have a giant CRM somewhere of all the providers in your region, how do you go about doing this systematically?
[00:38:52] Speaker C: How it first started is we actually established a relationship with an ACO. The ACO actually has 400 PCPs throughout their network and 80 specialists. That was the first major relationship that we had. We've just been building relationships through that network with our newer location viera. We didn't have that luxury, if you will, of being able to kind of establish that relationship with a large ACO like that. So what I have is our investigator within that area has ties to a lot of providers. So a lot of the times our provider will help engage other providers in the area to say, I'd really like to sit down with you, have my team come talk about how we can integrate clinical research into your practice. And then here are the various benefits that come from doing that. So that's kind of more of the organic approach. And then once you do really well with a handful of those providers, those providers are talking to other providers. And then it kind of is a snowball effect of hey, you guys really need to talk to ClinCloud because they're doing this great work inside my practice, bringing in clinical trials. My patients are loving it, I'm loving it. And it's just been a trickle down. Like this past month alone, we've onboarded six new provider practices in that area. But that took a lot of work, right? It took a lot of meetings and it took a lot of intros, but now it's finally taking off. So that's why I always say your provider relationships are going to be your long term, not a short term.
[00:40:28] Speaker B: And what's the incentive to them providers to be a part of this?
[00:40:32] Speaker C: So there's a few incentives, there are some financial links to it all based on the amount of time that they spend with the patient, kind of educating them. And then the other big ones are the diagnostics that people can get through the various clinical studies, especially on the screening side. And then once they complete a study, we're able to share some of the local reports, such as a brain MRI or a brain amyloid PET scan. We're allowed to to share. Most of the time we're able to share it. Some sponsors might not allow for it and we don't have access to IT labs. We're able to help provide updated labs for the providers, ECGs. So a lot of those key diagnostic pieces the providers really like, and I think the number one too is they feel like there's a sense of advancement in medicine that they now have access to. So we talk to them a lot about new medications that have just been approved or hey, this was a drug that we worked on three years ago and it's now new to the market. So a lot of these providers are looking at it as a sense of I'm staying at the forefront of how medicine is advancing.
[00:41:40] Speaker B: It helps that there's no risk of you as a provider as well, like also establishing a direct relationship with those patients.
[00:41:48] Speaker C: Exactly, exactly. Everything we do is in continuity with that provider. We are taking that patient for ourselves. And that's because we're a dedicated independent clinical research organization.
[00:42:00] Speaker B: The last part of your framework was patient databases. Talk to me about how you're leveraging your own patient database.
[00:42:06] Speaker C: So going back to when people first come in to see us, they typically are doing some sort of a prescreen. Right. Whether that's a phone prescreen, virtual or an in person, we're collecting data. So we're collecting medical history, medications, what your score on that memory semester assessment was, what your fiberscan score was, bmi, whatever it might be. We're collecting all that outside of a study specific shell. It's inside of our pre screen shell. Well, you can query all of those data points whenever you have a new study coming in to say, okay, how many people in my database have a diagnosis of depression? Great. Well I've got, you know, Now I have 550 people that I just flagged as having a diagnosis of depression. I've got this depression study that's coming through. The first thing we typically do is like a text blast out to those individuals, maybe followed by an email and then we allow for them to contact us. We also do the reverse. So if we don't hear from anybody we'll have our dedicated callers reach out to them on the back end. But a lot of times you find people that have either participated with you in the past simply as a pre screen or as an actual volunteer in a clinical research study and now they actually qualify for this new study opportunity. And if you do good work the first go around, they're going to want to come back and be a part of another clinical research study with you. I always like to say it's really important for you to treat clinical trials like your Disney World. So if you're a clinical research site you need to provide excellent customer service. You have to make sure this is a white glove experience because nobody has to participate in clinical research. They're choosing to participate. So I always say, I always tell my team, we're the Disney of clinical research. We need to be happy, we need to be providing the best experience for our patient. And in the end it's also going to provide the best experience for your team too, if everybody's at it together.
[00:44:04] Speaker B: Yeah, I mean research is scary enough as it is. I think we can all hope that the experience at sites is just delightful and hopefully a little bit magical if possible.
[00:44:14] Speaker C: Exactly. That's what I always say.
[00:44:15] Speaker B: I love that, I love that. Well, Jessica, hey, we've quickly bumped up against the end of our time here for this conversation. I feel like I can learn from you all day long but is there anything else that's just on your mind that you absolutely want to share about your experience working with Neuro with these patients, the things that you really learned along the way.
[00:44:33] Speaker C: I think the biggest thing is just treat your patients like they were part of your family.
That's the best way to go about it. And treat your team like they're a part of your family, too. Because there's long days that are entailed with clinical research, especially with this population, and everybody's going to have hard days when going through it, the patients, the caregivers, your staff, just because it's challenging. So just take it day by day and just make sure you're treating everybody how you would want to be treated and how you would want your family to be treated, too.
[00:45:09] Speaker B: Research is hard and there are no silver bullets. But it's awesome to have had this conversation and just learn from somebody who's innovating in the space and I think running a really tight ship in terms of the way that you're operating. So congratulations on all the success, Jessica.
[00:45:22] Speaker C: I really appreciate it. Thank you so much for having me. Of course.
[00:45:26] Speaker A: Thank you for tuning in. If you haven't already, please follow Power on LinkedIn, sign up for our live events and engage with us in the conversation. We hope to have you join us next time on Power to the Patients. Take care.
