The Clinical Trial Site of 2035

November 3, 2026

Imagine walking into a clinical research site in 2035. Do you see a fully virtual, site-less world, or something more grounded and human? On the latest episode of the Scope of Things, we take that thought experiment seriously and pressure-test it with two operators who live the realities of clinical trial delivery: Paul Evans from Velocity Clinical Research and Carlos Orantes, CEO of Alcanza Clinical Research.

With host Michelle Everill, the conversation keeps coming back to one inconvenient truth for anyone betting on pure decentralization: patients want options, and trust is easier to build when people meet. They get practical about what needs to change inside the site: the problems of site workflow, why so much clinical trial technology is built for sponsor back offices instead of the people juggling visits, data entry, and real-world surprises. They discuss why retention starts before a patient ever arrives, how better data access could reduce redundant eligibility questions, and why privacy and trust are the real barriers to centralized patient data. And finally, the three go bold on predictions for 2035, from designing trials around patient communities to removing access barriers like taxed patient stipends.

GUEST BIOs

Paul Evans, Ph.D., Board Chair, Velocity Clinical Research
Paul Evans, Ph.D., has worked in the pharmaceutical industry for over 30 years. He is currently chair of the board at Velocity Clinical Research, having transitioned from his role as president and CEO. From a private equity start-up in 2018, Velocity has grown under Paul’s leadership to be the largest site management organization (SMO) in the world, owning and operating investigator sites across multiple therapeutic areas in the U.S. and Europe. The company is focused on solving the delays caused by the inherent inefficiencies of the clinical research process.  This was particularly critical during Operation Warp Speed to the development of COVID-19 vaccines, for which Velocity contributed more patients than any other organization.

Paul started his career establishing and managing research sites in the UK and was a founder of one of the first European SMOs. He joined the CRO sector in 2005 building global site networks that partnered strategically rather than being selected tactically by the CRO and continued to work on innovative patient recruitment campaigns in some of the most challenging environments across all continents. In two of the world’s largest CROs he has led global functions that have included site intelligence, study start-up, feasibility, site contracting, patient recruitment, and investigator payments. Few people have had the opportunity to spend so much of their careers working both on the investigator and sponsor sides of the GCP divide and this breadth of experience gives him a unique insight into the challenges faced by the drug development industry.

Carlos Orantes, CEO, Alconza Clinical Research
As CEO, Carlos Orantes provides leadership and strategic direction for the site network. With over 32 years of experience within the life sciences industry, his career has included executive leadership, operational management, LEAN Six Sigma process improvement, as well as systems and technology deployment.

Most recently, Carlos served as executive director of site operations at Accelerated Enrollment Solutions, now Trial Med, a business of PPD later acquired by Thermo Fisher Scientific. There, he led the site operations for the Americas site operations in support of the company’s vast global clinical trial network.

Prior to joining PPD, Carlos served as chief executive officer of Amplify Clinical and Accel Research Sites, where he developed the business strategy to effectively compete in phase 2 and 3 clinical research involving multi-therapeutic trials and specialty vaccines. He also led activities related to both companies’ asset purchase by private equity.

Earlier career positions included COO for Frontage Laboratories and close to 20 years of operational, quality assurance, process improvement, and laboratory management roles of increasing responsibility at organizations including Covance, later becoming part of LabCorp and now Fortrea.

Carlos earned a Master of Business Administration degree from Old Dominion University, and a Bachelor of Science degree in Biology from George Washington University. He is a certified Lean Six Sigma Black Belt from Six Sigma Academy.

HOST BIO

Michelle Everill, CEO, Action from Data
Michelle Everill is a pharmaceutical R&D executive, entrepreneur, strategic advisor, thought leader, and leadership coach with more than 25 years of experience driving innovation, business strategy, and organizational transformation across the life sciences industry. Throughout her career, she has held senior executive leadership roles spanning clinical development, clinical operations, data, technology, and enterprise strategy. Her expertise lies in connecting scientific innovation with business and operational strategy, building high-performing organizations, and translating complex challenges into actionable solutions that improve performance and accelerate progress.

Today, Michelle advises and works with leaders and organizations navigating the evolving intersection of science, technology, business, and human behavior. She is particularly passionate about the future of clinical research, the strategic implications of AI and emerging technologies, and reimagining how the pharmaceutical industry operates to deliver greater value to patients. She is also the founder of The Hurricane Concept, a leadership and personal development platform focused on building stability, adaptability, and the capacity to thrive through change.

TRANSCRIPT

Welcome and the 2035 Thought Experiment

Hello and welcome to the Scope of Things podcast. I'm Michelle Everill, a clinical trial advisor and coach who spent 25 years optimizing clinical trials. I'm stepping in this month to guest host with an insider's look into the clinical research industry, game-changing operational trends, out-of-the-box approaches, and interviews with visionaries and stakeholders in the space. Today we will be teleporting ourselves to 2035 to get a glimpse of the site of the future. This is where AI has reshaped work, healthcare and patient expectations have evolved. And what about the research site? Is it essentially today's site with better technology or something fundamentally different? To explore that, I'm joined by Paul Evans of Velocity Clinical Research and Carlos Cerantes of all kinds of clinical research, two leaders with deep expertise and experience building and operating research organizations. Paul has recently taken a position of chair of the board at Velocity Clinical Research following his role as president and CEO. Paul has an expansive career in clinical trials spanning sponsors, CROs, and of course sites. He has a unique perspective on how the ecosystem works and how it can gain velocity. Paul, I'm sure there are other things other than velocity that you think about with your clinical trial sites. But anything else you'd like to add to your intro here?

It's as good a one as any. Maybe we should have done 2055 and see how it goes from there.

Ooh, I like the bold, the boldness here. Yeah, let's go. All right. And we also have Carlos Orantes, CEO of Alconza Clinical Research. Carlos has an altruistic mission. He has dedicated his extensive career to expanding the reach of clinical trials to people that require better access. His focus on bringing research as an integrated healthcare option to populations that need the most is truly inspiring. The name of Carlos's organization, Alconza, literally means reach in Spanish. How perfect. Did you come up with that yourself, Carlos?

Actually, I did. I did, I was at a coffee shop in Northern Virginia and came up with it saying that if we're going to do this, we might as well solve one of the biggest challenges that exists in the industry, reaching patients. And because I'm of Hispanic origin, I said, look, we've got to name it Alconza. So it wasn't a marketing firm, it was a coffee shop in Northern Virginia.

Amazing. And I love the mission. Love the mission. Awesome. I'm So happy to have you both here and talking with us today, as you are truly experts. You've seen it all So far. And I'm sure there's more to come here. Would you like to jump into the future? Indeed. All right. Maybe not 2055, but let's go to 2035 here.

Why Brick and Mortar Persists

All right. So we're jumping into 2035. I'm walking into or maybe logging on to teleporting to a clinical research site. What am I going to experience? What is fundamentally different from today? Does the traditional brick and mortar site still exist? Does this look different? Carlos, why don't you start with that one and then we'll see if Paul has uh more fun visions.

So I share a similar sentiment to Paul that 2035 is not that far away. Things take a long time to change in this industry because it's not what we want and what we need. It's always how long does it take and how do we convince everybody? And then the implementation change management is really the biggest blocker that I see here. So no different than the past. But what what I do see is the landscape is going to be drastically different in the size of site networks, the number of larger site networks. There's been a tremendous amount of investment to build scale So that we can provide a much broader array of services for sponsors, both large and small. So I do see that part of the landscape changing. At the actual research site, I still see brick and mortar. I know that there was some time that we started, you know, having aspirations of a lot less brick and mortar, and it didn't work. I mean, the patients still want to have that as an option. So I hope I'm right because you know we can't lose sight of the patient's centricity here. They want options, and one option is brick and mortar.

Awesome. Paul, feel free to follow that up. What do you think about brick and mortar? And then is there something that we will think of in the future that like was like, why did we do it that way? Why did we do that in 2026?

I agree with Carlos's view, by the way. This is about the patient at the end of the day. So, So you know, there was that period immediately after COVID that we all thought trials will go in decentralized. But you know, what we're trying to encourage people to do here when we run a clinical trial is take part in a very, very controlled scientific experiment. Not a word we would use in front of a patient. I understand that. And So trust is a key factor. And it's very difficult to build that trust unless you're actually eyeballing people. And I know I'm a dinosaur and we're all used to now working on Zoom and Teams and all those other things. But patients need to trust the clinicians that they're talking to. So for that reason alone, I think Carlos's call is right. I don't see it going away from brick and mortar. Perversely, though, I could make an argument for where I think a lot of the changes are going to come is in our use of data and technology to make the sites more efficient. Because of that, you could end up with a greater democratization of clinical trials. So we we had a system where clinical trials were done by full-time clinicians doing clinical trials on the side. That still characterize most traditional research sites. Then you move to the sort of full-time dedicated research sites. That's a more efficient way of working generally in any industry that you work in. But as we explore where the whole data and technology piece is taking us, it could make it easier for those clinicians who still want to be part-time clinicians, sorry, part-time researchers and full-time clinicians. It could make it actually easier for them to get involved and stay involved. Because one of the issues we have as an industry right now are the one and dunes. You know, the tough data says 60% of investigators only ever do one clinical trial. Probably most of the people watching this podcast are involved in clinical trials. And it's like, why are you surprised by that? Because we everybody, everybody that gets into a clinical trial realizes what all of us, including the listeners to this, know clinical trials are hard, they're tough. So maybe what the future will bring is with the help of appropriate, appropriate technology, an easier way to take part in clinical trials, which might start to shift some of the not the onus, but make it easier for part-timers to do the trials. But I agree with Carlos, we're not fundamentally moving away from a clinician eyeballing a patient and vice versa.

And that whole process of engagement and relationship and all of those things sound to be very, very critical. You actually brought up a couple of things I was interested in too, around, you know, we've tried decentralization, digitization. We know that patient centricity is really important. We know that there's all these AI things coming in. And my the question I kind of had initially was does this reinvent the site model, which I think you guys just said, absolutely not. The site model is not being completely reinvented. It will be making the model better. So if I'm thinking about improving that model, what's the biggest constraint? Would it be like incentives, regulation, technology, human behavior? What do you see as the biggest constraint of that model improvement?

I think

The Spinning Plates Problem at Sites

where where we need to improve things. Think about sites like this. And I sometimes think, I, like Carlos, spent time on the CRO side of the fence. And I think one of the things that sponsors and CROs sometimes forget is you can't reduce everything to a project management plan at a research site. So when people say to me, what's it like working at a research site? I always say to them, think about it like this. You know that old musical act where you spin plates on poles and you get 20, 30, 40, 50 plates spinning, and you have to get to the one that's about to drop before it drops. That's the day it day in the life of a clinical research research site director for sure, manager, but also a PI or a coordinator or whatever it happens to be. So that's what life is like at the site level. That's why you know the Gantt chart might look great that says this is what I'm going to do, but hell, there's a plate over there that's about to drop. I didn't even know was spin-in alone was about to drop. So there's an awful lot of move in parts from some serious stuff, you know, serious adverse events, for example, to relatively minor stuff, like, you know, one of the one of the sinks just blocked in an exam room, and now I haven't got enough exam rooms for all the patients that are sitting in the waiting room. And how are you going to deal with that? So it's it it goes from trivial to pretty major. But one of the things that I think the technology will need to do for us, and again, I'm sure Carlos will agree with us. The technology is generally designed. People say I did this for the research site. No, you didn't. You did it for the back office of the sponsor. Sorry, Michelle, I've said this to you before when you were a sponsor.

I love it.

You did it for the back office of the sponsor. So consequently, all these plates are spinning. Hooks helping the site staff to figure out which plate do I go to first. So think about AI overlaid on that musical act that's saying, go to this plate next, then go to this plate.

AI That Supports Real Site Workflow

And you better damn well get to that plate by the end of the day, or it will fall off. And that's where I see a lot of the AI coming. We're already seeing some of that now. I mean, there'll be a lot of people listening to this that are saying I use co-pilot every day. My my copilot drives me insane. It tells me every morning which emails I didn't deal with yesterday and things like that. I've already fallen out with my co-pilot. So I think that type of AI will start to improve the life of your average clinical research site member staff. That's where I see a big step up. And I can come to data too. We'll we'll cover that as we as we go through this. But let me let me stop and let Carlos tell me I've got that all wrong.

No, no, Paul, I think you're you're absolutely right. I think where AI, where I see it falling, you know, So we've implemented a lot of AI tools, and there is no shortage of AI solutions out there. Many that you saw this year that you didn't see last year, many you saw last year that you don't see this year anymore. And I think that the biggest thing from an AI to or any general technology perspective, change management is still the number one barrier. How are people using any of these tools with AI specifically? It's very powerful, but there's fear, there's unknown. And if you looked across an organization, even with something as mainstream as a Microsoft Copilot, it's still being used at So many different levels that, you know, we as an organization or as an industry think, well, this is great. We've implemented, check the box, but we still haven't solved a lot of the other problems, you know, to what you referred to as spinning plates. So it's it's still not fully implemented. What I do hope is that in the future, especially 10 years from now, because if we haven't figured that out in 10 years, we have failed miserably to really achieve the benefits of what it's supposed to achieve, is making sure that as we're implementing these technologies or So, you know, So-called solutions, we're taking the time to make sure the adoption, the implementation, and the actual benefit is being realized instead of just checking the box and saying, I purchased it, I implemented it, and it should be good, right? The should be needs to be verified. And if it's not good, we need to ask why. What else we can do instead of just moving on to the next specs, next shiny new toy that seems to be coming out almost every other month or every quarter.

Yeah, but despite my 2055 comment at the top of this, Carlos, that you know, the the sometimes it's it's hard to remember that maybe a couple of years ago we didn't have these tools. I mean, Anthropic's about to come to the market. It was only formed five years ago. Five years ago, Carlos, you and I were more focused on COVID than we were AI, even if we've never heard of AI prior to that point. So I do think the rate of change in these tools is what's going to be the transformational step. You're whenever you have to make change, then the change management piece always seems more difficult than the technology piece. But the speed at which you see these things moving on now, I think is what uh gives me hope that somebody will come up with the right answer. My my complaint very often, Michelle, because I've made this to you in the past, is again back to that point of yes, So what we need is a tool that actually works or tools that work at the site level. This is, after all, this is only about management of workflow. That's not that hard now that we have the computed power we have and the algorithms we have within our AI. What somebody needs to have to make that change work for the sites, to Carlos's point, is somebody needs to do it for the sites rather than the back office of the sponsor, because the sponsor, quite rightly, doesn't care how the data got to where I need it to be. They just need to make sure it's there, it's accurate, it's appropriate quality, and all those other things. They don't see the spinning plates. So somebody who understands what it's like to spin plates needs to put a workflow technology in place that will make that easier. In turn, that will do two things. It'll make the site more efficient, which would be nice because in the end, that's where you know, if you make if you make sites more efficient, you make it more cost effective. If you make things more cost-effective, you can reduce the cost of clinical trials. The great thing about reducing the cost of clinical trials is not profits for pri for finance, sorry, for pharmaceutical firms, it's more drugs developed because you you're dealing with a fixed pot. If you make clinical trials more efficient, then we'll deliver more drugs, not give more profit to the pharma companies. That's just how it works. So that's one thing that that we'll uh we'll gain from greater efficiency. And the second thing I think is important is if you're not spending your time trying to figure out where the plates are about to drop, how you can spend more time focused on the patient, which is what this is all about.

Sounds So novel, like, oh.

And and listening to you talk, Paul, you know, one thing that strikes me always when when I meet a potential new tool or a new technology, my question always is who is your target buyer? And and it's either going to be, well, we sell to the sponsors or we sell it to the sites. And So that tells me, to your point, who are they really building it in front of mind? And it isn't always the sites. And then the other challenge that exists is most these uh most of these technology vendors they prefer the sponsors because the sponsors are deeper pockets and So on and So forth. But but I think there needs to be sort of a reckoning that who pays for this needs to be secondary, although, you know, my my choice is always what the industry says. Well, the sponsor should pay for it, but it it does, it isn't always the case. And So I think we do need to have more technology, you know, producers really keep the sites front us, you know, front of mine here, work with the sites to develop them. And then at that point, you know, I think we as site networks, which we're doing a great job, we're we're talking a lot more than ever, I think, in terms of what works, what doesn't work, rising tides lift all boats. I mean, there's very often, you know, Paul and I have conversations. Have you tried this? How did it work for you? Wait a second, I haven't tried that. How did that work for you? Because there's So many choices out there. You know, So I hope that by you know 2035, again, using your number, Michelle, we've advanced a ball significantly faster, you know, because we are getting more choices, but they're not all created equal. The the actual technology isn't created equal. The support behind that technology is not all created equal. So we've got to make better choices. And I think that collaboration that's happening now more than ever is gonna keep happening with more players. I think we have what now, over 40 large site networks that are sponsored by private equity groups. Uh that's a significant change over the last 10 years. And it's phenomenal that we're having, you know, those levels, that level of interest and investment, because we can move the needle faster. You know, we certainly have So far in the industry.

And look at you guys coming together as friends today, right?

Friends.

You know, frenemies, is that a better term?

Collaborating competitors.

Collaborating competitors, I like it. I don't know if you guys knew this, but I actually was a uh at a site, a coordinator in that for probably five or six years in my earlier career. So I know exactly what you're talking about with the spinning plates. This was before a lot of technology was even in the the zone. I've talked to a lot of other sites that even you know, small sites that are maybe independently owned, where they feel like they need to have everybody in their team be technologists, is kind of the term that I've heard is tech, you know, technology savvy. Are there any

Automation That Refocuses on Patients

other skills that you see to help this adoption for your teens on the ground that are, you know, spinning the plates or trying to make sure the plates are not falling? Are there any skills that you see that could help with the adoption and the change management?

We've certainly been through that phase. And if you were a research coordinator like you were, Michelle, you you pretty soon learned that no matter what anybody told you, you were the first level help desk for any technology failures of the patient, right? Because even if you gave them a central number, no patient ever called it. They they didn't even call the PI, they called the coordinator, right? They liked you most, right?

So of course they're gonna call you.

Of course they liked you the most. So So you know that that's we did go through that phase, but I think the real promise of uh the technologies that are AI driven is how easy they are to use. And sometimes if you go and watch some of the old Star Trek films, I'm a bit of a trekkie. You go and watch some of the old Star Trek films and you look at some of the things that they talked of as technology. Well, we're now getting them. And you you no longer have to be super tech savvy. And remember, we're talking about 2035, So a lot of the tech is now diagnosing its own problems. We've just had the example where we used AI to find the flaws in uh websites that would allow cyber attacks. AI did that, not a human being, right? So AI, the technology figured out its own its own flaws. So here's one, for example, and that's why I'm optimistic, because that takes the pressure away from the site staff for being that first-line help desk. And here's here's a technology which we're not a million miles away from, which would make, would have made your job as a coordinator much easier. And the reason why I think we might end up with this is this is a common healthcare complaint. I'm using technology. Now I am sat in the exam room spending all the time looking at my computer and not looking up at the patient. Well, of course, we're now at the situation where we already have technology that automatically translates voice either to writing or puts it into uh puts it into the system for us. We even have translators. So just in case you're talking gobbledygook, why don't we translate techno speak to you know straightforward human speak? So we're not a million miles away from having technology that now allows you to go back to focusing on the patient, asking the patient a question, and not actually having to write anything in the EDC because it's being picked up and entered directly into the EDC. And if you think that's fantasy land, that's not 10 years away, because that technology already exists. So we can turn the focus back to the patient as well as making life easier for the coordinator. So, Michelle, how much would you have loved to be spending time talking to the patient rather than thinking, which box do I need to click on and why is that drop down not the way I want it? So I think these technologies will switch us back to being patient-centric, just uh, you know, just by the way that they the way that they work and operate.

And I love that. And that's exactly like that's the value in what we're doing too. It is everything we do is for the patient or should be anyway. Um, So kind of thinking about that, Carlos, like if we're going to go to this more patient-centric approach, what are your like top one to three? And and Paul, love to hear your take after Carlos as well. What are your top one to three things from a patient perspective that they would want in the future? Are they the same things that we see today? Is there anything different?

So I think with the patient, you know, it it's all about the patient experience. So patients here, you know, Paul said earlier, they they want. be able to trust. First, it's about identifying and making sure that they're aware, right? So we want to reach patients by making them aware of potential trials, you know, that might be aligned with with their interests or their needs. But then it's building that trust. And So I think for for me, all of this technology and we've implemented technology that's helping us reach the patients and also start the experience with the patients. Everybody talks about reaching the patient, matching them to a trial, getting them on a trial, but then it's by the way, retention is making sure that they have a good experience or want to stay on the trial and finish the trial So that we can actually provide, produce that data that's really the ultimate requirement to get that drug to the market. What I've learned is you know, through a lot of these trials and tribulations that occur, you know, in the world of clinical research, retention actually starts before the patient even reaches the site for the first time. And So there is great technology out there that has allowed us to connect with the patients, reduce the burden, increase the awareness, and start building that trust before they even get to the site, which to me is extremely valuable. So that, you know, as Paul said too is you know kind of eyeballing each other, establishing that trust. When you first walk through that door, who do you see? We call those individuals the directors of first impression, right? You walk through that door and you see a smile and then it goes to the coordinator and then ultimately the, you know, the investigator. But technology is helping us accomplish that faster and better. And So you you couple that with driving more, I'll say I'll call them efficiencies, but it's really to take away burdens from the site personnel So that we can do more things centrally and with greater quality So that the the the team at the site has more time to engage patients. So I tell everybody that doesn't work at a site is our job is to better equip and empower the sites So that they can do more directly with the patients, which ultimately increases and improves the patient experience. And if we keep that as a front goal, you know, in front of us here, it's going to keep improving the overall process. And I really believe technology is helping us do that.

Amazing amazing Paul, what would be your one to three things of the future of what's the most important thing to the patient?

It's a couple of things where the patient's concerned I just talked about imagine not having to stop and into data because the audio in the room's filling out filling out the EDC for you. That would be that would be nice and I do think that's achievable on a on a 10 year time span. I think the other thing that technology will do a lot for us is in the in the realm of data. I think at the moment there is a lot of data on patients but it's really not all that usable and accessible. Even EHRs you know nobody's nobody's made a solid case for example I'm sure Carlos will agree with me that you can recruit large numbers of patients directly out of an EHR. I've never seen that done I've seen a promise many many times but I've never seen it be hugely successful. You know you can point out one or two patients in any clinical trial but you know there's a couple of reasons for that. One is you know data patient databases are not in very good shape. So most of the information you need is simply not there. But I think where we're going certainly in in 10 years' time we should be in a case in a position where more of our data as a patient is in one place and in a useful form. I mean you can go to central data repositories now but if you ever actually tried using one what you get for somebody at my age is you know half of the Amazon rainforest if you printed it out on on paper. But of course where AI takes us is in better being better able to interpret all of that and just give the evidence just give the information you know that this CRC Michelle needed back in earlier in her career. Here's the important stuff you need to know Michelle this stuff over here you don't you don't need to know about this at all. So I think we will have better data repositories. That presents its own challenges you know I'm obviously European try and tell Germany we're going to do that they'll have a fit on the on the data privacy side. So I do think there are issues we have to overcome which is back to trust which is if I'm going to share my data and look that's not new Google said they were going to do that for us what 10 years ago still isn't there right So are we willing to put all of our data in one place So we we have a trust issue to overcome the technology one we can overcome I think when that data is there that will allow us to better recruit patients in the first place because we we can stop asking stupid questions. The problem Carlos and I have now is we do patient outreach. We like to think we do it pretty well if you're on the receiving end of that you've got a patient who's thinking how many more idiot questions are they going to ask me you know when you can get this information easily accessible elsewhere again that all smooth through the process. So when the patient turns up at a site in 2035 all of the information we need on them is at hand and you might say yeah well you and Carlos come from that background where you're not dealing with your own patients. It's different if it's your own patients I would argue no because even within your own EHR all of the information you want is not there. It's in other places So this consolidation of data I think will uh has the potential to transform clinical research too. So I want that from the point of view of the patient experience I want that from the point of view of being able to better able recruit to recruit patients. You know one of the things if you really had the right information you could quickly determine now there's one thing you don't know that's critical are they willing to take part in the clinical trial So let's focus on that rather than are they eligible? Our whole industry is built up around eligibility not willingness well again if you've got the data So you're now pretty clear on eligibility let's focus on what's really important which is willingness which is all back to patient trust, patient centricity all the things Carlos was was talking about So those those are the two areas where I see we can make giant leaps. And the reason I'm optimistic we can do it is we don't just need that for clinical trials. We actually need that for a better healthcare system. So it makes sense to do it.

Absolutely absolutely and I think you guys hit on the really key points you know privacy trust and choice. And then Carlos I loved your retention comment around how that actually starts the second your first interaction and then how do you build that patient community through So it's not just like they do one trial and then they're you know out in the ether again. You know, what does that relationship look like and and how do they maintain connected with their data as well through their clinical trial and and make sure that their needs are being taken care of and especially in specialty populations.

Are

Specialty Populations and Uneven Regulations

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Carlos, would you like to touch on anything else in the specialty populations? Is there anything differentiated?

No, I think with with specialty populations the one thing that strikes me is that the the smaller the pop the target population or potential population, there I would like to see us in 10 years from now have So many efficiencies and technology that there you there there doesn't have to be special treatment because there's less attention for those populations. Yes or or less available options for those populations. We ought to be at a point where we're making it more accessible reaching more of those particular patient populations. And So I'm I'm hopeful and you know Paul touched on you know privacy laws being different between countries. The regulatory laws are very different as well. And I certainly don't expect harmonization of that in you know 10 years, 20 years or even 30 years, maybe not in my lifetime, but at some point it it it there shouldn't be such a difference as well be you know country to country because that makes it even incredibly more difficult for global pharmaceutical organizations, global you know site network organizations and and we just need to focus on the patient again is why is it So different?

It shouldn't be perfectly said. Perfectly said. And we we should keep dreaming for this harmonization thing. Maybe that's a 2055 goal. I don't know. Awesome. So kind

Site Scale, Investment, and New Capabilities

of thinking about the future of the site or the site of the future everything that we just talked about and how things may be less burdensome, more patient centric. Does anything change with the business of the site how they get paid who's doing what which investments pay off? Carlos, you're you're laughing. Let's see what you have to say here.

So I think first I need to share and I may have shared this with some folks in the past 10 years ago I was invited to a meeting hosted by an organization and I walked into the room and the title on the PowerPoint slide was Sightless Trials. Right. So that was 10 years ago when there were very few larger site networks and an aspiration to go sightless right and So fast forward to today we're not sightless. In fact we're very much brick and mortar and there's very much a a palpable momentum to invest and grow the site infrastructure. So when I look to see what's coming, you know, 10 years from now, I see even more scaled organizations, more capabilities to support the patient communities, to support the sponsors and make the investments, you know, again to provide more support to the sites to equip and empower them. And what I continue to see is is more excitement, more entry into the space and more competitive collaborators, which is great because together we're going to be able to do more together and we're really we're moving the needle. I mean I think what we're doing today if somebody would have said 10 years ago this is going to happen, there were still a lot of naysayers. No way it's not going to happen. And it's it's happening. And So what I see now in 10 years, there's going to be even larger scale with even more capabilities, more investments, because we see the returns on those investments greater, you know, greater quality greater efficiency So that we can dedicate more resources to touching the patient, right? Even building patient communities well before they even know about a site or a clinical trial. You know, talk about changing the paradigm here if if we could learn more about the patients, all the data that Paul says that we should know about the patients, let's not burden them with asking them all these questions about a trial. We should know when a trial is a better match for them So that we can't just focus on building that trust to get them to use that trial as a means of obtaining their outcome, right? That's required, whether it's a requirement for their health or whether they want to do something good for society. So I can't wait you know to see what 10 years is going to bring of additional investment because the site world is changing very fast.

Yeah. And if you think about just supply and demand, right? We were just talking about how technologies are typically built for sponsors, even in the 10 years we've seen technologies built for sites. We used to have to build everything ourselves right and now we're seeing that evolve and change. So yeah more supply of sites the more demand that there is going to be needed. I just see that getting better and better for everybody. Yeah.

Oh I go back to something I said earlier it if we make the workflow more manageable for sites, you actually democratize clinical trials. So the standard model I or traditional model as I often refer to it as the the uh full-time clinician doing trials part-time that model doesn't work and the the proof of that is 60% only do one trial as we said earlier right So I think if you really find a way to make uh improve workflows improve use of data improve access to patients for recruitment purposes just generally you open up the industry to more players So I think Carlos is right I think you will see people uh operating at scale more and more and more because after all the the the the number of dedicated research site models now is is still pretty small in the grand scheme of things. And if you get outside of the US it gets even smaller pretty quickly. So I think that improving data improving workflow actually makes it more likely that people that get into clinical trials stay with it. So that we don't all sit there in the future Michelle and say well I know why that is it's because everyone learns clinical trials are tough.

Maybe we make clinical trials easier to do and that in turn promotes more um engagement in clinical trials for the physicians I mean yeah imagine that would that be nice do you think the models that you guys have could expand more globally do you do you have any thoughts on that?

Well I mean you already see some of that I think some of the challenges I mean velocity operates in three European countries. I'm still

Going Global Without Losing the Plot

never quite sure whether to count because I'm an immigrant here whether to count Puerto Rico as America or not and that's where Carlos it --Carlos has insights

Carlos was the expert yep. Yeah

So yes what it gets complicated Michelle I think some of the reasons why you don't see it in Europe for example is you've got socialized medicine and and socialized education. So you know medicine in theory is free. Well it's not the government pays for it comes out of taxes education it's not quite free but you don't have physicians coming out with the level of debt they do in this country. So they're less entrepreneurial. So you know as as most people who ever tried to acquire sites in Europe will tell you there's just fewer of them to acquire.

But I think the principles that we're talking about here however those models evolve apply to any type of site not just the type of site that Carlos and I operate but as I say you're you're hopefully no longer one and done but the two three four five time investigator that's what you'll see more of in places like Europe Latin America you'll you'll probably see more efficient smaller sites you won't see the scale I guess that that we're we're gonna see in the uh or we're seeing now in the US that's a point of view right now ask me in 10 years time if you Carlos what do you yeah Carlos what do you think I know you're a little bit more in like the the Latin America communities and there's there's definitely the activity in the US as Paul said is farther ahead whether it's in the second third inning it's much farther behind in the rest of the world and So but the world is paying attention So Latin America is paying attention So is Europe there's there's more activity in Europe than obviously than you see in Asia Pacific, et cetera but it's the everybody sitting up and and asking questions. I can tell you that at SERS Global last week, the amount of Latin America site network locations that either operate single sites or a couple of sites, they're very interested in the scale that we're building in the US and in other parts such as Europe. So I'm I'm excited I'm excited to I'll be at SERS LATAM in a couple of weeks and there's a lot of meetings lined up and So I think the the world's our oyster down there and speaking the language and being very familiar with the culture I think is what draws me you know to to that part of the region. But you know the interest is is elsewhere. It's not just US, Latin America, like I said, Europe. I think the complexity needs to be very well thought out and very smart colleague of mine who's operated in a few different parts of the world well it's Paul but I didn't I wanted to see if you would guess you know I asked him So humble Paul I did. No I asked him if you could do this all over again, you know, and and you know he he has he said the complexities of the different countries, the cultures, the regulatory and So I think we need to be careful as we grow because it's not the same doing business in different countries. And So you know we're excited about the opportunity and it needs to be done the investments and the the professionalization of the centralization of all these you know sites around the world it could definitely you know improve drug development in those areas as well. But you've got to do it carefully.

Carlos don't you think that you know the problems that we've been talking about today up till this point are the same wherever you do in a clinical trial whichever state you're in whichever country you're in you know they those those challenges of complex workflows and spinning plates are about to drop and data we don't have and things like that. That's the same the world over the solution if you could fix those the way that people take those solutions and adapt them will be cultural. So Latin America won't work the same way as Eastern Europe or Western Europe and Asia PAC will be a law into itself. But the problems are actually no different whichever country and I think I've been involved in clinical trials in over 50 different countries one way or another but at the heart of it the problems always seem the same to me. How people use the solutions will vary.

Think that's fair I think you're you're absolutely right but I do think that when you're dealing with US regulatory requirements and then you have other countries trying to do things on for the US for example or for a US customer I think there's an added level of complexity because if you think about the technology most of the the technology companies out there it's interesting many of them are stemming from the US with US you know operating customs and principles and then I would imagine there's an added layer of complexity when you go to a different culture, different language is not just a matter of plugging in a translator and So I haven't been exposed to that too much but I suspect it's going to be there. We saw that it just operating in Puerto Rico it's there's some nuances that if you choose to ignore you're gonna run into some trouble. There's no question about that.

Worth bearing in mind though Michelle that when you look at the data one third of the global research sites are in the US that's a big number but it means two thirds are somewhere else it's huge.

Yeah and Carlos we do have to know is Puerto Rico part of the US do we should we count it as the US I absolutely I absolutely count it as part of the US but I can tell you that my colleagues and and friends in Puerto Rico aren't always aligned on that.

Really? Okay. It's an interesting conundrum okay So it could go both ways that's that's great. And also what I just heard from you guys, both of you guys, basically all the things that we need to remove and I'm sure there's some brilliant technologists listening to this podcast right now is how do we get through the same problems because they don't really change So much but how do we how do we kind of tackle those problems but maybe put some spin culturally to make sure that they're applicable, that they can be adopted and that you know technologies can solve a good proportion of this maybe not everything, but something that we can really kind of springboard that to make clinical trials easier to bring in more sites to create more of those partnerships and increase the supply of these sites globally.