Podcast: How to improve site selection, the challenges of vendor selection, and how Clinicom was born from a site

Recently. Clinicom’s CEO, Ignacio Handal joined host Bradley Hightower on the Note to File podcast.

Ignacio Handal, the CEO of Clinicom Healthcare, has a rich history in clinical research, having completed numerous FDA phase I, II, and III studies in pharmaceuticals and devices over two decades. His contributions to the field were recognized in 2022 when he received the Christine Pierre Clinical Trials Lifetime Achievement Award, a prestigious honor bestowed upon only eight clinical researchers globally.

Ignacio co-founded Harmonex Neuroscience Research in 2003, which has become the 5th leading private CNS research site in the US and continues to thrive. The profits from their research trials over the last twenty years have been fully invested in developing Clinicom, the world's first online mental health assessment software. This innovative platform can remotely assess individuals for 81 mental health conditions in a single virtual adaptive ML assessment.
Clinicom's impact is global, serving patients across six continents, helping them find clarity on their mental health journey. Additionally, Clinicom has been instrumental in accelerating enrollment and patient identification for precise inclusion and exclusion criteria in 70 phase II and III studies in the US.
The mission of Clinicom is to give every patient a voice and to bring equity and access to mental health care. In the podcast episode, Ignacio discusses how to improve site selection, the challenges of vendor selection, and the origins of Clinicom from a clinical research site perspective.

Bradley Hightower: Hello, and welcome to the Note to File Podcast, a collection of interviews, best practices, and candid commentary for clinical research sites. I'm your host, Brad Hightower. Guest to speak is Ignacio Handel. Ignacio is CEO of Clinical Home Health Care. he's completed 100 of FDA clinical trials across all phases, and has over 2 decades of experience. In 2022, Ignacio was honored with 1 of the highest honors in clinical research, the Christine Pierre Clinical Trials Lifetime Lifetime Achievement Award, of which only 8 clinical research globally have ever been awarded. Ignacio and his team have used a 100% of their profits. From the research trials over the last 20 years to develop the world's first online mental health assessment software that can assess anyone remotely for over 81 mental health conditions. Clinicon has helped patients all over the world financers on their mental health journey. clinical has also helped accelerate enrollment and patient identification for precise inclusion and exclusion criteria in 70 phase 2 and 3 studies in the US. their mission is to give every patient a voice and bring equity and access to mental health. Clinacom currently serves patients on the 6 continents. look, I'm a real big fan. Ignacio, Unfortunately, our interview got cut a little bit short due to some technical difficulties I was having. So if you have the opportunity, go to Notify podcast.com. Check out the live stream. the Ignacio did, in which he demoed clinical. It's a really impressive system. and I feel like an audio interview doesn't really do justice to what clindacom is putting together. So make sure you head on over and check out that live stream. This week, we discuss how to improve site selection, the challenges of vendor selection, and how clinical was born from a site. So without further ado, Ignacio handle. Alright. This week, we welcome Ignacio handle. Ignacio. How's it going, man?

Ignacio Handal: Hey, Brad. How are you doing today?

Bradley Hightower: Rocking and rolling like always, where, where are you coming to us from?

Ignacio Handal: I'm in, Southern Alabama right by the Panhandle of Florida.

Bradley Hightower: Yeah. So, it's always nice. I rarely talk to people who run the same time zone as me. I know that seems like insignificant, but central time zone, it's just nice to have somebody on the same page.

Ignacio Handal: Yeah. you know, we're I think the central time zone, we're the the most confused, right, is it e we're working eastern people and the Pacific, so it's always trying to adjust time.

Bradley Hightower: Yeah. No. I do a lot of, I mean, simple addition and subtraction, but, yeah, I feel like it's never, I'm never talking to someone in the central time zone. Somebody's having to think twice. Anyways, I just want to jump in the same way I do with, you know, all of our guests. I always find it really interesting to hear people's backgrounds in terms, specifically about clinical trials. So tell us about your origin story, what brought you into the clinical trial space and kind of, you know, catch us up to what you're doing today.

Ignacio Handal: Yeah. Thanks, Brad. I've been doing clinical research for nearly 20 20 years, starting in 2003. we launched a CNS research site here in Alabama. That is now we're told is the 3rd leading private CNS research side in the country. We've probably touched ninety percent of the CNS drugs have been released to market through phase 2 or phase 3 studies in the last 20 years. A 100 plus studies dozens and dozens of drugs and devices to market, we went on to create a research site at the 3rd largest surgical center in the country, Eye Center South, And then after that, I was tapped by a CRO to be a director and lead designing studies, selling studies, and executing studies globally. Across multiple, you know, countries and organizations and really, you know, using the site experience that I had I was expecting to go into the CROs and thinking that they knew everything, and I actually had the opposite experience of, like, realizing what they didn't know. And how things really worked. so it was a really eye opening experience for me. And, since then, you know, our site, our CNS site, in the of doing studies, we really needed a tool to triage patients for mental health, to screen them, to assess them, so we do own clinics and TMS centers, and we also own our our research site. And we realized very quickly that, you know, we're measuring low and slow for CNS sites. And then on our clinical side, you know, there wasn't a lot of tools available to assess people other than some paper instruments. For triaging a baseline for mental health and tracking metric based care. So we spent the last 20 years. A lot of our profits from our clinical research studies developing a tool called clinical. And since, you know, we've just recently in the last 2 or 3 years commercialized that product widely, And now, you know, there's at least a clinic on-site and every continent now on the planet. but we basically, clinic can assess anybody anywhere remotely for most of the conditions in the diagnostic manual for psychiatry basically send somebody a link. They go through an augmented intelligence, so it's not a survey. It's an adaptive intelligence that asks the right questions or the right patients to screen you for about 80 conditions to the standard of the diagnostic manual for psychiatry.

Bradley Hightower: Nice. That's, that's really interesting. And, you know, at first, you know, I'll drill down a little bit because, like I say, I always tell people there's always a a soft spot for anyone who started working on sort of the site level and having to sort of go through that struggle and see what it's like. And then to make the jump to CRO, guess, how did you, I mean, you kind of touched on it a little bit. but, I mean, how did you find that that transition? You know, a lot of people at the site level want to go to the CRO side, you know, it's a pretty popular topic, I see site level folks talking about.

Ignacio Handal: It's a hard jump to make. a lot of people, you know, struggle with making that jump. A lot of CROs want to hire CRAs that, you know, started as nurses, then they go to CRAs and then they don't really have that site experience. And so it it was, it's a it was a challenging jump to make, but then it was also very eye opening to, you know, what seros really do. I mean, I've worked with 50, 60s different seros over 2 decades, and they all have, you know, their idiosyncrasies and their ways and methods. But I think the experience of having worked with so many and seeing how many, what vendors they use, what processes they have, be able to compare and contrast that and bringing that to a global CRO and adding flavor to say, hey. You know, I've seen 2 other people try that. That didn't work. I've seen other people try that. You know, maybe, you know, whatever experience we had from that, but Once I was in there, it was really it was eye opening to see the process and realizing that CRO is really our project management companies to administer regulatory safety data gathering, but on the clinical execution side, you know, the sites are really the experts. The sites understand the therapeutic areas. They understand how to measure what to measure and the detailed process of that. I know the c r CROs have to manage the data and the output and the regulatory side of all that. But I I still strongly believe that even after my CRO experience that the sites really run the show. I mean, they do all the work. The CROs are just gathering the data and you know, compiling it and making sure things are done safely and the safety alerts are done and that everything's done to the regulatory requirements. But the sites are are truly the experts and the people that understand how to bring drugs to market and do the the heavy lift. so I, you know, I every every day I get more and more respect for CRCs and PIs and sub eyes because you know, to me, the coordinators, you know, I I started as a coordinator. I I get it. You know, they do most of the the work. For clinical trials, and I don't I don't think they get enough credit. You know, people always say, the PI, this, the PI that, but the truth is the PI gathered some data, but 80% of that lift to the side is gonna happen from the CRC. Yeah.

Bradley Hightower: I think it's pretty least again, if you've worked at a site level pretty well acknowledge, like, obviously, we need PIs, we need their expertise. we need their oversight, play a big role in patient safety, but frankly, A lot of them don't understand all the other nuance and sort of ins and outs and, you know, day to day challenges, that the CRCs are are having to do. I mean, think about how practices run. You know what I mean? They've got nurses and MAA's and schedulers taking care of all that stuff. Well, a lot of times it's one person on research and it's the CRC managing all of that. So, you know, including regulatory and maybe even budgets and contracts, depending on how you're structured.

Ignacio Handal: So Imagine a doctor's office with no nurses. Right? That's what it would be like without, you know, with no support staff, no scheduling people, no admin people, no finance people and no nurses. And the doctor is just trying to do it all themselves. You know, it just wouldn't run.

Bradley Hightower: Right.

Ignacio Handal: And so that's the analogy I give for the CRC does all that typically. Right? Even sometimes not a 20 month. Yeah.

Bradley Hightower: No, it's true. It's true. Do do you think that, you know, sites aren't appropriately leveraging their expertise? It still feels very much like they're sort of at the bottom of the totem pole, and a lot of the interactions, whether they be, you know, financial or, or otherwise.

Ignacio Handal: I feel like groups like society for clinical research sites, you know, for the last decade or so, have been trying to augment the voice you know, Sean, over there and Marcus have been doing a great job of, and the team really over there had been doing a great job of augmenting the boys within the sites to the sites. But I think we we haven't done enough of a job of augmenting the voice of the sites to CROs and sponsors to give them more of a voice. So, typically, if there's an issue or a suggestion or an idea, a site has that their only voice to that megaphone is to their CRA. Right? And then the CRA may may or may not make a comment to their director. And then, you know, it may or may not get put in. And I think there should be more of a line for important things above the communication line from just the CRA or just to the project manager. A lot of people don't realize know, when I was at the sites, I thought the project manager runs the whole show. Right? And in reality, the project manager's executing the plan that the director and the executives at CRO are telling them to do, and they stay within that box. Right? They don't have a framework to work outside of that box or think outside of that box. They are 1, 2, 3, 4, 5, and follow the sequence. And so, you know, if you're looking to execute change, and add suggestions to your CRO from a site level. I always suggest reaching out to the program director, project director, clinical director of the CRO that's overseeing that project manager, because those are the people that can make a difference. Not necessarily your CRA or your project manager. And I think that's an important thing that I didn't know when I was at the sites. You know, we we could still own our sites and still operate them and And the other thing I think I would comment on is that, you know, we have expanded our sites and tried to build a network of sites, kind of a mini SMO and trying to bring therapeutic treatment options to doctors that are interested in doing research, and we've done that on several occasions in bringing you know, new PIs in. And I think the key the key linchpin and and doctors are trying to get in this space maybe they've done a been a PI in residency. Maybe they've done it's been a sub eye, but without a good CRC, it's a no go. Right? Like, the CRC makes it or breaks it for anybody entering the space. And I know in doing site selection as a director when the project manager gives me the sites and the lists and the CDs and we go, yeah, or no, typically, and to give that approval, the the big question is, okay, what's the experience of the PI? What's the bandwidth right now for the PI? And then the the next question is, How good is their coordinator? Like, how many studies have they done? Somebody who's done coordinating 1 or 2 studies, you know, it's it every study is different as you know. Right? You have flex and you have to learn and you have to do things differently. But, you know, once you've passed the 10 study mark, most CRCs are pretty grounded. It can get the next 20 studies, right, it can get it done. The problem is the data shows from global data that most PIs do one study and they don't ever do another study again.

Bradley Hightower: Right.

Ignacio Handal: You know, I think it's like 60 or 70%. I don't know. Call me on this number, but it's a high percentage have done less than 10. Right? And out of the 390 something 1000 PIs in the world, only 393 according to global data have done more than 50 studies. So that's our problem. Right? So we gotta get regular doctors involved in studies, and we have to start training and hiring more, you know, every nurse in the country should learn how to coordinate. And every nerve, you know, you should have every decent sized practice should have a coordinator, and we should augment training and access to learning how to become a clinical research coordinator and the validation of that.

Bradley Hightower: Yeah. There's stuff played a lot more to do. And interesting, I've had this conversation a lot recently. We like you guys, we, you know, we embed with private practices. And, we also work with a large health system and even trying to sort of replicate that across you know, some potential new clients and other health systems. And I think it's oftentimes just sort of seen as something people think you can just scale up real fast. And I think what you're pointing out is one of the big reasons why you can't, and I think not just a good coordinator who has experience and technical ability, but a lot of it's about the fit and the match between the CRC and the clinics in they work. Like, you know, you can be a great CRC, but if you don't get along with your PI, your PI is not going to cooperate with you, or the clinic manager is not going to cooperate with you. Or the nurses and MAs that you have to integrate and work with, are not going to, to cooperate. And it can become a challenge. It can become contentious which is gonna, you know, obviously make the PI be like, I don't wanna deal with this. This is a bunch of extra work. Nobody's happy. And I think that takes time. It takes time to develop those relationships as well. And that's where as much as I sometimes hate to admit it, like, maybe this is not the most easily scalable thing, right? It just takes time and it takes effort and it takes relationship building?

Ignacio Handal: I think you're right, Brad. I think you're also hitting on a a point that I think we've also faced the challenge of of you know, you can find a PI that's really interested in bringing new therapeutic options to patients. A lot of the doctors that we have worked with in the past are like, hey. I want this, not because I just wanna have extra revenue, but, you know, my patients have tried 4 or 5 different things. And for the guy who's tried everything and nothing in the current working, I wanna be able to give another option. And that's why we did clinical research to start with, you know, very challenging cases that we got, you know, child psychiatry and and adolescent psychiatry that the current medicines weren't working. We wanted to give families another opportunity, another option. I think the biggest challenge in trying to expand a site to other PIs, and I know there's many sites after they've been in business for 3 to 5 years. They start thinking themselves well. Know, there's all of all of these other doctors in my community. How do I get them involved? How do I grow my site? How do I get my footprint? And the best advice I can give in having tried this in many different ways is if you try to convince a very busy nurse to also be a very busy CRC, It's not gonna work. Right? and and that's the person who's always gonna give the negative feedback to the doctor going, this is too much. I can't do this. Right? Slow it. They slow the whole train down. Right? It's excited as the doctor may be for your study in enrolling. They could also slow you down on enrollment and, you know, just say, hey, I just don't wanna do this this week. you know, I'm not gonna screen anybody. And so my my the way we've kind of solved that is, you know, going to ACRP, and everybody, you know, whether you're a member or not, you can go to the American Clinical Research Professionals group. And there's a listing there of trained and certified coordinators looking for jobs, you know, and you gotta pay them well. You know, you you're you're not gonna turn your MA into an excellent coordinator overnight. And so why try to recreate the wheel when there are existing people that you gotta pay? You know, you gotta pay them decent. But you can hire them and bring them in and they can come in running. Right? They can come in running and do regulatory and do the things that you need them to do. and and if you do that and provide that extra person, so it's not on their main nurse, the PI, all of a sudden, gets really excited about research. And really excited about the treatment options. And then, hopefully, tertiary get excited about the revenue we could bring to them.

Bradley Hightower: Yeah. Well, and again, I think it it's up to us to make it easy. Quote, unquote. We know it's not easy, but I think to make it as easy as it can be, because again, a lot of these especially private community based positions, there's maybe struggling, not struggling, but, you know, they're focused on keeping their practice up and running and, you know, giving their patients the attention they deserve. and to your point, a lot of want to participate research, but, you know, just don't have that infrastructure. I mean, there's more and more, you know, companies maybe like what you're doing and like what we're doing, coming to market out there. I think it's becoming more prevalent, becoming more well known. Probably, I don't know about you, but mean, I came into this industry just completely by accident. I had no idea what I was getting into. And I became, you know, research assistant at the local university. but now there are people out there coming in very intentionally. And I think we, we can, we can utilize that to your point instead of trying to sort of split time, make it a mess, you know, and take advantage of the people out there who are pursuing opportunities.

Ignacio Handal: I don't, I don't think a lot of the private sites or people entering the private site space understand the real power that they have in gaining access to these therapeutic trials you know, in the sense that, you know, you know, it's 30 years ago, 40 years ago, it was the academic centers doing all this. Right? And so the researchers were all it went a lot slower. You know, academics aren't making extra money if they have 10 studies or 3. So there's no hurry for them to enroll or get things done. So as the private site space grew in the last 20 or 30 years, you know, a lot of CROs and and pharma companies realize that, hey, you know, these private sites can actually get this done quicker, you know, get more of a focus on it. And so, you know, when, a a study director at a CRO is looking at the site selection. You know, one of my main rules was always like, you know, don't ever give more than 20 or 30 percent of the sites to the SMOs. They'll always over promise you and tell you that they're gonna get you a 100 patients, and they'll get you 3. Right? Don't over overweight, you know, the getting the guy from Harvard and Yale and and getting those big brand names in, they're gonna cost you three times as much. They're gonna be a lot slower and the the outputs left. Right? So I always try to get at least a, like, a 50, 60% focus on private sites because, you know, with experience, And I think one of the things that, you know, as a former, you know, one of the things we did to improve site selection. So let me back up a little bit. I think everybody or maybe they don't know the biggest challenges in in the cost of slowing down a study are, 1, poorly written protocol with poor inclusion exclusion that needs a men that always costs money and time that slows everything down. And then poor site selection. Right? Port selecting a third of the sites that that a CRO or pharma will pick for a study will not produce a single patient. So there's all that time wasted in launching them, setting them up, training them, and nothing happens. Right? So our system was broken for many years based on site feasibility questionnaires. Right? You get a survey at a site. You fill it out. You say what you can and can't do. How many patients you might be able to fit. And for many years, that's all CROs had to go on on making an assessment other than your CV and some of the history you may have. Or or a previous history of working with them. So if you didn't have any previous history, it was hard to see. But now there's, you know, amazing tools like sight line. You know, and I know that was a big thing I pushed for the 0. I was at, guys, we gotta use sight line. It's like the Bloomberg terminal clinical research. Vattingglobaldata.com to see, okay, you know, I like SlightLine better than global data has more data. You can actually see, like, the bandwidth of a PI. So instead of using an SF Q, you know, you can literally say, okay, look at Brad's site, how many studies he's currently doing, not by his opinion, but, like, what the data shows, how many studies are you registered with, what is your bandwidth, right? How how much experience do you have in this therapeutic area? What competing studies do you really have And that tool is kind of democratized site selection in my view and that every single study in any CRO or sponsor, small form, or otherwise, should make the investment to get into that because to me, that that's a game changer. Right? If I can look at a side and go, hey. The number one expert in the world who everybody wants to do the study has 30 studies for this. And he's also a clinician. And the number 2 guy in the world, he's got 2 studies for this. Who do you really wanna hire? Right?

Bradley Hightower: Right.

Ignacio Handal: Or maybe the number 5 guy, he's got 10 studies for this. He's done before, and he's got no studies for this particular TA right now. I really need him, right, over that number one guy. And so it I really think it's democratizing that site selection process. People do not realize that every day lost in a study cost between $800,000 and up to $3,000,000 in lost revenue for pharma per day of lost sale of product. Right? So every day you're not enrolling, every day you're late to deliver, It's a tremendous amount of money lost. So just picking better sites, and in my opinion, private sites, you know, changes the game. It moves a needle big. You know?

Bradley Hightower: Yeah. No. I mean, that makes makes perfect sense to me, and you actually, you know, take the take advantage of the data available set of sort of auto piloting that, that, that process. And then, I mean, let's go beyond that, you know, now, and we talked about a little bit before we we started taping, but decentralized and, you know, going beyond your traditional, you know, sites, whether they be private or academic or whatever the case may be. I mean, or how big is the value proposition there? I think you and I, maybe we share the sentiment that maybe not as much as initially thought, but, I mean, where How much does that add it to the mix here?

Ignacio Handal: I think it's tremendous. I think it has a tremendous value, but not on a stand alone basis. So not all studies, in my opinion, have the potential to be completely decentralized or completely remote. You know, what everybody talks about decentralized is really a hybrid approach. Right? So some inpatient insight visits and some remote visits. Via telemedicine or some remote gathering tools like clinical. Like, that's what we, you know, we do as well for life sciences, gathering CNS data remotely. But I think there's a misconception that, you know, any company that has access to patients can all of a sudden you know, launch a decentralized clinical trial company. And I, you know, I call it Silicon Valley of Vaporware, right, a bunch of people that all of a sudden think I can get some money together and enter the space. They don't understand the space. Never worked in the space and don't have the relationships to even sell in the space because this is a trust industry. Right? You don't just get 30 studies when you start. You get 1. Right? And you build up trust over time, And if you break that trust one time, you're done. Right? So if you've been in this business for 20 years, it's because you're doing something right and honestly and and with standards. And so I think, you know, the best tools I've seen emerge have been tools that have literally emerged out of sites. Right? I mean, look at real time CTMS, Rick, over there. Right? I mean, his his family owns one of the biggest sites in Texas. Right? look at Lawrence Healthcare, you know, Ryan Jones and that team. You know, they really understood the the process. So I think, pharma companies and people investing in this space should really look at, you know, what is their true knowledge of the space, not just, hey, Tom Dick and Harry worked at so and so pharmaceutical company for 5 years. That doesn't mean anything about clinical trial or knowledge. That is on the execution and operation side, that means almost nothing. You know, it's really important to to not compare apples with apples and also to understand the difference between you know, somebody with deep relationships and experience versus an idea with money behind it.

Bradley Hightower: Yeah. Not I mean, I think it's validating to hear somebody else say that because I I feel like I feel that I feel that a lot. And I see these things and I'm like, K, these conversations are being had, but not by someone who's actually, like, done it or been down in it, and not the good ideas can't come from anywhere. We obviously can't, you know, and, and they should. And I do appreciate outside or perspective, but I can't tell you how many phone calls I take with people who have an idea or whatever the case may be. And it becomes real apparent. They don't understand some of the most basic issues, they're gonna prevent that from be even being able to be done. So, you know, maybe it's a mix. Like, maybe it's more collaboration between those sort of people down in the trenches, you know, like your, your real time. I mean, a real time's a great example. I use them. I love those guys. Like, you can tell in the product they built, it came from years of experience dealing with it. And you don't eat that with a lot of other stuff again. I mean, you know, if the vaporware analogy is not too far off for a lot of these things that, that we're seeing. And I think that's for, for me, I mean, that's scary. I don't like that, right? Because we're down here seeing patients every day, which we want things to be better. We want to contribute, but that doesn't get the attention or necessarily that it's not as, not as sex and exciting as some of these other things that are sort of destined, I think, to fail, but are giving so much more attention.

Ignacio Handal: I'd like to also comment on how a CRO makes a vendor selection. So the vendor selection process is pretty cumbersome. You know, they have to get the pharma company's approval. They have to have a budget for it. So there's not an infinite amount of money. So when you have a budget and you're sold a study, that's the package you sold. You might be able to add one thing to it, make a change order, but you know, when it's in motion, it's in motion. So trying to sell to somebody who's got an actively enrolling study is not gonna happen. Right? So there's a time delay. And then also you can't just keep adding vendors to a study. So there's been studies on how the impact of these decentralized trial vendors have had on the cost and time to execution of clinical trials. And the the fact is it's making studies take longer and cost more, right, because you're adding stacking vendor upon vendor and then all of a sudden, the complexity increases and things just take a little longer anytime you add more Lego pieces. So, you know, if we're trying to make studies go faster, you know, you need platforms, not point solutions. Right? You need things that are, like, real time that do 10 different things, not just one. So if you're out there investing or putting money into or thinking of a good idea and it's a point solution, I would say that, you know, it's gonna be pretty challenging for you. I would also comment that it's really an issue of you know, convincing a pharma company of, hey, you need to use this. And that is like moving a mountain.

Ignacio Handal: That does not happen overnight. And if you don't have the cash flow or the investment to see that through, you're gonna have trouble. Right? I mean, it's not you know, you don't convince the the Pfizer of the world to go buy a a vendor or something overnight. Right? That doesn't happen. so there's a lot to be said about what that needs to look like or or what that could be. So

Bradley Hightower: Yeah. I mean, Pfizer's still using shared investigator platform, unfortunately. So we would certainly, we know it's not a, it's not a quick and easy thing to get away from. I wanted to hear a little bit more about clinical. Is that being utilized as sort of a is using that in clinical trials? Is it being used in trials to collect, you know, data?

Ignacio Handal: Yeah. I mean, we've, we've used it to, you know, One of the hardest things in CNS trials is getting a good baseline. Right? Getting a good understanding of the comorbidities somebody has or does not have. And typically, the old school way of that being done is the PI sent down with the patient and checking some boxes. Patient's not schizophrenic. Patient's not this. And it's like an opinion sometimes based on a bunch of questions and a lot of digging in. And sometimes it's literally a doctor just going check Right? And so that's not a really good way to to assess somebody.

Bradley Hightower: Right.

Ignacio Handal: And so, you know, the example I give is, you know, if you have a depression study and all of a sudden you have 4 or 5 bipolar patients that present depressed that end up in your study, your data's gone. Like, you skew an entire study because those patients will not respond to SSRIs or other things. Right? They actually will make them worse and more manic. So you can destroy an entire drug, not because the drug doesn't work, but because you put the wrong people in. And so our goal of clinical, you know, we've been we've used clinical to screen our patients at our sites for over 70 studies as a prescreening tool to triage the patients. we can also look at assessing inclusion exclusion criteria. So we put load the the complete inclusion exclusion. So one of the things I don't wanna name a a recruitment company, but I'm I'm frustrated with recruitment companies that send you a list of a 100 patients and say, I got you a bunch of patients. And you call 97 of them and only 3 of them fit. Right? Think of all the time wasted from your CRC and your management staff just trying to dig those out or using crystal reports or something to look through an EMR data to find people that you know, you can get half of the inclusion exclusion figured out, but the other half, you gotta, like, still dig. So what we wanted to do was create something where I load the entire detailed inclusion exclusion And this tool can literally remotely screen 1000 people remotely and triage the list and sell me, you know, these 10 actually make full inclusion exclusion, not part of it, but the entire thing, these don't, using the same standardized instruments built in that we use for clinical trials, but done remotely. And then it also kinda can show, you know, what what inclusion and exclusions are failing. So maybe you can do protocol adjustments before you launch your study. You can use it as a pre site selection tool to say, hey, hey, Brad, you you got a new depression study. I'm gonna send you this tool. Send it to your, you know, you put on your SFQ. You got 50 patients this email them to these fifty people this thing, and let's see how many of them actually qualify.

Ignacio Handal: Right? So you can actually do deeper dive site selection and actually see if it's real or not. And that's something sight line can do for you. Right? And then also, you know, we can also build the the the the the the visit schedule into the platform and connect that to an ADC. So basically, you know, any of the assessments you need to do either in person or virtually can be gathered virtually or entered in directly through the portal by the clinician, and then it just pumps into the EDC.

Ignacio Handal: So what's beautiful right there. We, we've been mainly focused on selling through clinicians. Right? We sell mainly to clinicians, ERs, primary care, therapist, psychiatrist, psychologists, but we are, I guess, entering the life science space, even though we've been in the life science space for 20 years as far as selling the product commercially there. And that's kind of a newer thing in the last year for us, because we really spent, like I said, almost 20 years refining the tool before we even try to sell it. And the only reason we were able to do that is because of the lucrative clinical trial site that we own and using the profits of that to fund this. Because, you know, that that has been, you know, instead of going out and spending those millions on Ferraris, we put it back into bringing equity and access to mental health. And so, you know, I'm passionate about it. And also, aside from life sciences, one of the most cool things I think we can do is you know, if you said, hey, triage an entire school, 1000 kids, do it in 24 hours. You can literally pick out who's aggressive, who's suicidal, you know, give me the entire list of the veterans administration. I can triage that whole list and tell you, okay, these are the suicidal vets that need to be seen today. These are the guys with TBI, you know, and really kind of meet people in the middle where people don't realize that a psychiatrist is there's 60 percent of counties in the country have no psychiatrists psychiatrists are more rare than librarians. You're more likely to run into a librarian than your psychiatrist.

Ignacio Handal: It's crazy. And so there's a lot of, you know, there's 800,000 Calcers up in the country, and they do a lot of the lift, but they need help. Know, they they don't know how to differentiate sometimes between asperger's and autism and schizophrenia and psych, you know, the different variants. And so ClearCon's kinda like the guardrails. Not necessarily a diagnostic tool, but a clinical decision support tool to say, hey. You know, I can take care of this guy myself, or maybe they need to go to a higher level care.

Bradley Hightower: Yeah. And I love that. Obviously, it's still an incredibly unmet need at this point. Right? Yeah. Well, very good. Ignacio, we're, where can people find you and, online where can we learn more about clinic com?

Ignacio Handal: Yeah. So, I mean, they can just go to cliniccom.com and check us out. Though we offer free trial for any clinician trying to, use it if it's a a research side or a private practice or a primary care even, pediatricians. Anybody can go register for free and use it, for free for 30 days. And one of the big things and people think I'm a little crazy when I when I say this, but one of the main things we wanted to accomplish was equity and access. So that also means, you know, a really low price point. So it's only $12 per patient. And that's a initial global assessment with unlimited follow ups for a year. So you can track and measure somebody every week, every day, or every month unlimited for a entire year for a simple $12. And the reason we did that was, you know, we also wanted, you know, other countries and and and some thorough countries and other places that need affordable access to care and affordable triaging of mental health to be able to afford this. And, we've been wildly successful now. Like I said, we're in 6 continents and growing every day and just every day. I'm seeing more and more clinicians from all around the world sign up. It's been a really exciting and a 20 year labor of love from, also our chairman and my father, who's a distinguished fellow of the American Psychiatric Association of really laboring over this, beast for many years. I mean, it it was a challenge to take the entire manual for Piatry, layout questions that align to each criteria, and then build adaptive augmented intelligence algorithms that triage you through that. So that was not an easy lift. I mean, most medical device companies that create something for one condition or 2 might take 5 or 10 years.

Ignacio Handal: Right. We are now able to screen 80 conditions. So it took a while. And, we're glad that now it's out to market and, helping lots of people everywhere.

Bradley Hightower: Yeah. That's crazy. It's, you're open to it, come on the live stream sometime, maybe, maybe demo if you're willing, willing and able not put you on the spot, but I really like to use that sort of veg more visual medium to, to do those sort of things. But, otherwise, you know, anything else before we sort of wrap up here?

Ignacio Handal: No, Brad. I appreciate, you know, I just wanna thank you, Brad, and thank you for the work you're doing to bring awareness to the challenges that sites face. I love your commentary on LinkedIn and and some of the things that you do to kind of bring a a softer touch and a more humanistic touch to the realities that sites face. And I hope that, a lot of pharma and seros are paying attention and and taking notes. So thank you for what you do.

Bradley Hightower: we'll see. We'll see if they are for better or worse. But either way, yeah, I'm, I'm gonna keep keep doing it. And, you know, I appreciate you being part of that ecosystem. I mean, you know, that's why having these conversations and having being transparent and, you know, filling in the gaps. That's really all I wanna do. I think we talked about that. I mean, it's just so so many gaps that exist.

Ignacio Handal: Yeah. The last thing I'd like to mention is if anybody, would like, you know, to get into the space of creating a side, there may be their clinician and want to get into the space, I had shared with Brad, a deck of, you know, kind of our standard tool kit, SOPs, and stuff. And so wanna make that readily available to anybody that wants to enter that space. They can contact me through the support at clinic com, and I'm happy to share that entire start a site toolkit up with anybody that wants to learn more.

Bradley Hightower: Yeah. I know that was super awesome and generous. I'll make sure I'll link that in the show notes too. And, yeah, I mean, she should come back on here in a few weeks, do it, do it live, and, we can elaborate on some more of these things and, you know, kind of go from there. And, like I said, I'll put all your contact info and and clinicals as well in the, in the show notes, man. But I I appreciate you coming on.

Ignacio Handal: Appreciate you. Hope you have a wonderful day. Thank you so much.

Bradley Hightower: As always, thank you so much for listening to the Note to File Podcast. make sure and check out Notetoofilepodcast.com. For our previous 86 episodes and check out our weekly live stream Tuesdays at noon Eastern. Thanks, guys.