Sept. 16, 2022
Nicholas Focil, CEO at Fomat Medical Research
Nicholas Focil is the CEO at Fomat Medical Research, a network of research centers based in Oxnard, California. Nicholas graduated from California with a Biochemistry and MBA degree. During his undergrad days, he spent his extra time in a research lab working with a nominated noble laureate performing investigator-initiated studies, and publishing weekly articles for a spectrum of publications. Was then recruited by Medtronic MiniMed Diabetes division to do pre-pivotal trials. Thereafter, was recruited for the purpose of managing and expanding Diverse Research Solutions. He then spearheaded the spinoff and expansion of FOMAT Medical Research through both the U.S. and Latin America with current operations in the USA (California and Florida), Ecuador, Colombia, and Peru. With well over a decade of research experience, Nicholas, as the CEO of Fomat Medical Research and proud founding partner of hyper core International, continues to innovate and pioneer clinical research in both regions.
WEBVTT
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Welcome to the Latin Metech Leaders podcast, a conversation with Metech leaders who have succeeded or plan to succeed in Latin America.
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Please subscribe on your favorite podcasting platform.
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Welcome to the Latin Method Leaders podcast, a conversation with leaders who have succeeded or plan to succeed in Latin America Today our guest is Nicolas Fo, CEO at Format Medical Research, a network of research centers based in Oxnard, California.
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Hey, Nicolas, thank you for joining us today.
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Welcome to the show.
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Thank you.
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Thank you for having me, Julio.
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Thank you for having me.
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Awesome, Nicholas.
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I'm so pleased to be here today, uh, recording these podcast episodes.
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Uh, you and I have been friends for I don't know how many years, and, uh, we've been one way or another in contact, and, uh, I've been following your steps.
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You've been following mine.
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So I've, I've always wanted to, to have you on camera and, and, uh, and to record the, an interview about your, your experience about your plans and your journey to Latin America.
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So let's get started with your journey.
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I mean, how is it that you got to where you are today in Latin?
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Well, first off, thank you for having me, and, um, I've been, you know, I've cherished our relationship.
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Thank you for, for, for this and, and it's exciting, uh, to have a 30 minute break with you.
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Um, so the journey, the journey I was, I was born in California, raised in California for the most part, um, but to parents that are Hispanic.
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And, uh, so I've always known that, you know, some of my blood blow, you know, flows with, uh, Hispanic culture, if you will.
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And, um, as I graduated college, I did research, I did Pivotals, uh, I did bench research.
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I worked under a nominated no Laureate.
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I then worked at a bio, uh, medical device company, sorry, doing pivotal trials, uh, pre pivotal trials and, um, kind of working between the ClinOps department and research development department.
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So I had a lot of experience from kind of that angle.
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And then I got recruited by site management organization called drs.
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And at the time, um, they were focused on California growth.
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DRS stood for diverse research solutions.
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It was more of a diversity in re in research.
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And, um, you know, my father, who was a clinician and researcher, he was part of the board.
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He was a board member at that company.
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And he, you know, told them about, about me.
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And they, they, you know, they recruited me.
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They brought me on board, and I was part of their, their team in ca in California.
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So, um, at the time we got recruited a company, a special company, and a very close friends with them to date.
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They, they saw something in us and they saw that they needed more, uh, either recruitment or diversity or, or in this case, it was had to do with the seasonality of diseases where, you know, in the United States or in seasons and Latin Americas are in seasons.
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So, um, they wanted it to, to, you know, put their position in their company in a place where they could, you know, recruit in both seasons, if you will.
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So they asked us and the company at the board level, half the board, or you know, percent of the board, if you will, was interested in, in expanding and taking set opportunity to open Latin America while the other was, you know, let's focus on California, let's, you know, let's be laser focused.
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So I saw this as an opportunity, and I kind of going back to my roots and saying, you know, what, wanted to explore what it would live like in Latin America.
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Um, I took, I jumped on the opportunity, so a, a spinoff, a sister spinoff company called Pharma Medical Research was built to open in Latin America.
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And so they, they were two separate companies, but they worked so closely together, um, almost inseparable.
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And, um, I sat on both of them, their both management teams, but I was a leadership over here.
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I was a ceo, kind of managing director, if you will, of format.
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So as, as I kind of expanded into South America and what an experience, what an amazing experience, I've, um, it was phenomenal.
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We outgrew drs uh, four or five years later format actually acquires drs.
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Oh,
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Okay.
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Yeah.
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So, and today, you know, we, we sit in California, we actually have some growth in Miami at some point, but then we've, we've since just focused on California in, in Latin America, our US business now sits, as you know, of predominantly the largest part of our business.
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It's more than, you know, 90% of our business, I would say.
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But Latin America is still very much in our roots in everything we do.
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I mean, we obviously do research and everything in Latin America, but the expansion, the way it kind of flowed, um, it enabled us, the success in the US has enabled a success in Latin America, and the success in Latin America has enabled us, and the success in us is very synergistic in so many different ways.
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And, um, and yeah, so now, you know, fun, then went, acquired drs, and now it's all kind of one big, uh, fun company.
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Fun family,.
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That's
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My story.
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Yeah, it's about having fun, I mean, into to the world and, uh, making a little bit of money here and there.
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I mean, Mo is not really the r I mean, what you guys do, what we all do, I'm also involved in greater research is fascinating to see the, the outcomes that you reach with all these innovations patients, how you can change their lives.
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At least put medical devices, implantable devices are just fascinating.
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So anyway, I'm going off topic.
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The point is that, uh, I, I admire what you do.
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Uh, thank you for sharing your, your journey.
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It's a fascinating one.
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And, uh, I'm so glad that you got reconnected with your roots.
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Yeah, I did.
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I did.
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And, you know, throughout the process and learned a lot, learned, Oh my gosh, you learned so much from, from mistakes and, and you learned probably more from mistakes.
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So I've had a few of those, and yeah.
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So yeah, that was the, yeah.
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But luckily, you know, as long as you keep on pushing forward, it's always been very, very, a very fun ride.
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Yeah.
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Yeah.
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All right.
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So Nicola, let's talk about, uh, trends in Latin America that are relevant to our discussion today.
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What do you see happening in the region, uh, that, uh, you see are win to make it more appealing for clinical research?
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Well, I think a big one, a big one that's happening right now that's very specific to the recent, you know, uh, to our recent history, uh, of a, of kind world current, current, uh, what's happening right now in the united, in the world is, uh, the, the, the wars Ukraine and Russia.
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So that hasn't, is having a direct impact on Latin America.
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And people's like, Wait, wait, what?
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And, uh, so when the us many of the pharmaceuticals, see, I mean, we can kind of go into details as to kind of how they strategize, but, um, usually that region of the world is in competition with Latin America.
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When you, when it's a, when it's a bidding process, and this sucks to say this because obviously you don't ever wanna, um, benefit off of something, something nega something negative, if you will.
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But given that, that area of the world right now is, there's a kind of a question mark.
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You know, when does the war end, um, kind of what, what is, what does the aftermath look like?
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Um, you know, logistics, you know, bringing kits to taking out kits, uh, monitors, recruitment, uh, your, you know, your, your compliance, retention, et cetera, et cetera.
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That, um, even, you know, from, we can go into further detail on, on kinda like all the implications of that.
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But so as a strategic perspective, Sorry.
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No, I was gonna say the MDR too is affecting, uh, the environment in Europe.
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I mean,,
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Right?
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Right.
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They're busy research centers.
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I mean, they can't keep up with all the research that they have to do now.
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,
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Right?
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That, that too, that too.
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But spec when it comes to specifically Latin America, the, in, in a competition, when you're like in the, the war room or strategy room, if you will, in Pfizer, and call it, you know, med tech, biotech, pharma, um, kind of, you know, your first tier, you, you know, you got the, you got certain like Europe, the North America areas that kind of, uh, that sit as like maybe your first tier places you have to be at.
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But then your second locations and sometimes your third, there's, there's re they, they're, they're broken down by regions, you know, and, and regions that we fight against are gonna be your Ukraine, your Russia, uh, those are very much where I would say 80, I don't know.
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I'm throwing this percent out, but more than 50% of studies that Latin America today loses is to that region.
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Wow.
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Eastern Europe in general.
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Yeah.
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Yeah.
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Eastern Europe in general, Right.
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Eastern, I'm not speaking only Europe, Ukraine and Russia.
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I'm speaking Eastern Europe.
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Yeah.
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But, but there's, again, there's a huge question mark, you know, do these other countries get involved?
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Um, do you know how, what is the aftermath?
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What about flights?
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You know, what about electric?
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What about electricity?
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What about, you know, there's a lot of, because there, there's, there's a scare of of gas being, um, controlled by Russia.
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So, so there's just, all of these little uncertainties are now being, because clinical research is a very trust driven industry.
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So if you do a, if I do a job with you and you do a good job, I'm gonna come back to you.
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And if you do a good job, again, I'm gonna come back to you again.
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Why am I gonna take a risk on this person over here?
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I'm not really, I don't know who they are.
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If I've done this job and is doing a really good, I'm having a really good relationship.
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Uh, so we've seen that time and time again where, where Latin America comes a little short to Eastern Europe, just a little short, always, because they already have this track recruit of the history.
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But for the first time caused by, had to be a war, unfortunately.
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But you're, you're seeing where there's like this uncertainty over there, and there's, there's a lot of, the pipeline is becoming larger and larger for Latin America.
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So I, I do expect in the next 24, 36 months to see a, an increase, a large increase in Latin America, which is kind of be interesting.
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Cause at first is everybody's gonna be excited, but then as kind of time progresses, there's gonna be saturation of the market, there's gonna be, So, you know, I, I'm very interested to see, you know, where we are three years from today.
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Very good.
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Interesting.
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All right.
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And, and I will also add that countries are becoming, uh, a lot more mature in Latin America.
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I mean, there are middle classes growing.
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Their economies are stronger.
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They're joining the we c d and that's a big deal for Latin America.
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For the first time in history, we have all these countries, Brazil, Chile, Columbia, Costa Rica, Peru is in the Saint Path.
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Brazil is in the Saint path.
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So the we CD is really, really, uh, making an impact in Latin America by, by increasing the, uh, the, the, uh, standards, uh, that this country have to abide to, you know, best practices for social policies, economic policies, et cetera.
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Even clinical research policy.
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There's a document from the c d on how to do clinical research, how to regulate clinical
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Research.
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That that's awesome.
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Yeah.
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So, yeah.
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Anyway, so, um, so yeah, go ahead.
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I'm sorry.
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There's a little bit of a connection issue on my end.
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Um, but, but you're absolutely right.
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You know, Latin America is, and it, it's kind of difficult.
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Many people like try to like sum all Latin America together.
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You know, there's, there's certain countries that maybe, and, you know, you have the, the right politics versus the left politics.
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There's, there are some difference, but if you wanna talk it as a whole, you are seen, uh, a kind of an acceleration in these countries and standardization.
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Uh, and the beauty of it is, is because if you can see what works, right?
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If you're kind of like, from the outside forward, you can see like, what, what's working in these countries?
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And you can kind of implement them.
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So you're seeing like, you're, like, you like what you just mentioned, um, those things, like tangibly, objectively make your country better.
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So, right.
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So now you're, you can make that decision knowing, okay, there's a clear path.
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If I do this, then this happens.
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And you're, you're starting to see Latin America.
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It's hard to say all Latin America.
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Cause I don't think it's all, but, you know, a vast majority of Latin America taking, taking these kind of strides towards, towards improvement, towards standardization, towards equality.
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Um, and, and, and yeah, I, I totally agree with you on that.
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Yeah.
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Yeah.
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All right.
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So Nicola, let's talk about, um, what you're doing today.
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I mean, uh, what's, how is your involvement in Latin America now?
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I understand you had, uh, a big involvement in Ecuador.
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You had some involvement in Columbia and other countries.
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Please, can you elaborate a little bit on that?
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Yeah, absolutely.
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So we are a, a local cro.
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So one thing that I, I, I think the main, um, success of any project really in Latin America is finding the right partner.
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And, um, you know, Julio, I think that you're, by the way, amazing, by the way.
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I, I've told a lot of people about you.
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And, and, and for those who are listening to this podcast, I would definitely recommend them.
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Um, you know, it's, it's, it's about being able to communicate and, and there's a cultural aspect to that, right?
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There's a cultural nuance there that I think is super important because for, for a, for Latino, like myself, for example, um, when somebody says, Hey, I'll be there in 10 minutes, I'll see you in 10.
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You know, it's, you know, you know, that means like, Hey, I'm on my way.
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I'll be there in 30 minutes.
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Right?
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You have, you have time to get a call.
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I'm
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Even taking a shower.
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Yeah, you exactly.
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You might still be at home taking a shower.
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You haven't even left.
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But, you know, for, for maybe, you know, the US that, you know, I'll see you in 10 minutes means 10.
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So having that person that has the clinical research expertise, but able to speak it in both cultural languages, not only Lang, not even like English and Spanish, but cultural languages, it's so in, it's invaluable really, because they'll able to translate, no, he's not gonna be here in 10 minutes.
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The do sign a shower, and he'll be here in like 35.
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Let's go get a coffee.
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You know?
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And it gives you time.
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And not in, like, from a regulatory perspective, from a patient recruitment perspective, from a, you know, from your importation expectation expectations, it allows you to plan better.
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It allows you to do, uh, project.
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Yeah, project management is huge when it comes to like a global project.
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And I think that is one thing that these local niche, uh, CROs really have, have that your global CROs might lack.
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Uh, because the way that, that the system kind of works from a global perspective is you usually hire local, which is great, don't get me wrong.
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But then you don't have that, that's lived one foot in both countries.
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Yes.
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Right?
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Yes, exactly.
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Like, you're exactly like you're calling me right now for Miami.
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I think you're, I think you're in Miami, right?
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?
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Yes, I am.
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Yeah, I am.
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Yeah.
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Yeah.
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So you're in Miami, so you, you kind of, you've lived this world and you live that.
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So that kind of, that dichotomy, or I don't know if that's the right probably word for this right now, but, uh, it, it's super important.
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And that's kind of where I think we excel because, uh, in large part, we have that kind of symbiotic relationship between Latin America and the United States.
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Many of our countries, many of our contracts, uh, will sign'em, the US so they can sue us here if they need, if, you know, we do something wrong down there, they can sue us here.
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Yeah,
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Exactly the same.
00:17:02.509 --> 00:17:02.509
Yeah.
00:17:02.830 --> 00:17:03.269
You know, we're company.
00:17:03.590 --> 00:17:03.590
Yeah.
00:17:04.079 --> 00:17:07.390
So I think that's, those little, those little details are important.
00:17:08.150 --> 00:17:11.349
Um, but yeah, I mean that's, we have presence in Latin America.
00:17:11.351 --> 00:17:17.309
We do, you know, phase pretty much all phases, phase one's a little bit less to be completely frank.
00:17:18.190 --> 00:17:23.390
Um, and in some countries we don't have presence, but we have local partners that we work with.
00:17:23.890 --> 00:17:27.069
And, um, and so that's a kind of a little bit of different model.
00:17:27.829 --> 00:17:29.150
Uh, it's the same concept though.
00:17:29.151 --> 00:17:35.390
Again, still having that relationship, still having that knowhow locally, but we don't have, it's not our boots on the ground.
00:17:35.391 --> 00:17:37.470
It's our partner's boots on the ground.
00:17:37.930 --> 00:17:41.430
And, um, but yeah, so that's kind of our, our footprint across.
00:17:42.009 --> 00:17:50.079
And, um, and yeah, I mean, from a local cro, so we do let regulatory IRB importation exploitation, your, you know, your monitoring services.
00:17:50.339 --> 00:17:58.319
But where we also kind of, where we started our company, and this is where our, we specialize, is our site management side things.
00:17:58.319 --> 00:18:00.039
So we actually do the recruitment.
00:18:00.040 --> 00:18:03.599
We actually do the, the visits in some of our countries.
00:18:03.601 --> 00:18:04.118
That's the one.
00:18:04.119 --> 00:18:08.400
We don't do it in all countries that we only do in the ones that we are physically in.
00:18:08.401 --> 00:18:11.480
But, um, and the other is more of a local cro.
00:18:11.690 --> 00:18:19.759
So if you need ask help in, you know, entering to Mexico if you need help, like that is where our local side enters local CRO side.
00:18:20.599 --> 00:18:28.960
Um, if you need more help recruiting, so with our doctors, with our coordinators, you know, that's more of an like an Ecuador thing, You know, you want a vaccine research.
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