#414: Why Global Certification is the Future of Clinical Research in Latin America

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Etienne Nichols: Hey everyone. Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. I'm the host for today's episode. It's today I want to talk about clinical sites. Specifically how clinical sites in Latin America.

Etienne Nichols: Are raising the bar and joining the.

Etienne Nichols: Global certification for clinical trial excellence. As clinical research gets more global, more competitive trial sites and professionals, they're under increasing pressure to demonstrate not just capability, but excellence. And so in this episode we want to dive into the launch of a groundbreaking certification in the accreditation program for IAOCR and gcsa.

We'll talk about what those are in just a moment, but it's now available in the Americas and and Julio Martinez Clark is going to join us to unpack how this international standard is redefining quality in clinical research, enhances site credibility and opening new doors for medtech companies helping to de risk their trials and accelerate global market access.

So if you're a sponsor, a CRO, a research site leader, this conversation should be your guide to staying ahead in a high stakes, quality driven industry.

So just a little bit about Julio. Julio Martinez Clark is the CEO of BioAccess, a US based contract research organization specializing in medtech clinical trials across Latin America. With over two decades of experience, Julio helps medical device companies accelerate first in human studies by leveraging Latin America's faster regulatory pathways,

rapid patient and recruitment, cost effective, globally compliant data generation. He's also the host of the Latam medtech Leaders podcast and the editor of the Latin America medtech Pulse newsletter where he shares insights from industry innovators shaping the future of clinical research in the recent region.

And we'll put links in the show notes to those. But before I get too verbose, Julio, great to have you with us. How are you doing today?

Julio Martinez-Clark: Thank you for having me here. It's a pleasure to be back in contact with you and being back in the show, it's my second time.

I did a great job on my first interview.

Etienne Nichols: Absolutely. The one thing I love the most about you is your passion for the industry and you're always putting out more. I mean it's not just content. We throw that word around content.

But you put out white papers, I feel like, and very informative content, which I strongly recommend. Those of you listening, go, go follow Julio, see what he's published. But let's get into this topic.

So you were telling me a little bit about this before we got on these certification. Can you tell us about what these stand for and what, what it is we're even talking about with these certifications for clinical.

Clinical research?

Julio Martinez-Clark: Absolutely, I think. Well, it is an organization that originated in the UK a while ago, years ago actually.

The healthcare system, the AHS, the national healthcare system of the U.K.

they got the needs to up their bar in clinical research and the major global CROs, IQVD, PAR, Excel, Senior Health, they all wanted to have like a global standard for research Excellency in the network of sites and there was really nothing available.

So they got together and they came up with the process to certify the quality standards that a world class research site should have. And also the professionals, the individuals that are participating in the research team of these trials.

It is just appalling that there was really nothing like this in an industry that deals with lives, that deals with patient safety and there was really no certification and accreditation process for sites or individuals to validate how competent they are in, in executing trials and managing status, et cetera.

So the organization put together the certification process for sites and also put together the accreditation process for individuals. And by the way, that accreditation process follows a UNESCO framework for education.

So it is really something that is backed by great expertise and a global framework. Anyway, the point is that slowly it has matured and in the past four or five years has become more and more common.

Started as I said, in the uk,

it has extended to Western Europe and now you have sites that are C certified in gcsa, Quality Excellence in the Americas, in the Middle east, in South Africa and now it's available in Latin America.

And officially we launch because I'm part of the team that is promoting this certification now, because I'm part of the Viking Board, we are promoting this in North America, in Latin America.

We just launched a brand new website targeted for this region in the world and we're very excited about seeing sites in Latin America come on board with this quality standard.

Etienne Nichols: And I want to just kind of revisit one of the things you mentioned there with UNESCO. For those of you who are not familiar with UNESCO, that's United Nations Educational, Scientific and Cultural Organization.

So it's kind of a big deal.

Julio Martinez-Clark: So, so yes, it is something.

Etienne Nichols: Yeah. Why? So I'm curious, why now? Why do you think? What has led to this? At this point? What I would imagine going back to the beginning of clinical trials, it was always something that would have been helpful to have, because instead of looking, if you look across 10 different sites,

10 different organizations, someone with a certification, maybe they're not the best, but that at least gives you some indicator that they care and they're working at it. So what, why now?

Why is this happening now?

Julio Martinez-Clark: That's a great question. And I think research is in a point in its evolution where the treatments are getting more and more sophisticated.

We have many, many more trials than before. Look@clinical trial.gov you look at the hockey speed trajectory of the number of trials that get initiated. Every year is just unstoppable. And before we only had vaccine trials,

investigational drug trials, and now we also have medical device trials, which are the new frontier of clinical research. On top of that, we have something that very few people are talking about, which are theranostics,

radiopharmaceuticals. That's a new thing that started a few years back.

So you have these large amount of different therapies available to the public in investigational stages that. Whereas before we only had a couple vaccine trials and a couple drug trials going on, but now we have even larger and larger numbers.

I think it's about more volume of trials.

Of course, we need more ways to certify and accredit the sites, the organizations, the individuals, the professionals that are participating in these trials so that patients feel safer. And also I think the issue of diversity and inclusion, that's a major issue.

So how can you portray to your prospective patients that you are a quality researcher, that you are a quality organization?

You need to have a seal of approval by a third party to validate your competency in the field. And that will put patients at ease, that they are joining a trial that is run professionally and with quality, with excellency.

I think it's a confluence of factors that is making the certification very timely.

Etienne Nichols: I think, I think you're right and those are some really good points that you address. And I also wonder if maybe some of the regulatory pressure from something like emdr, with increased clinical evidence requirements, maybe also, you know, just kind of driving up the pure number of trials that are starting to take place.

And a few other things. You know, I can think of the, the proposed, if not final, ruling on wound dressings and just other things. There's lots of different things going on in the regulatory world that are really driving this as well.

That aside, you know, I want to kind of dig into the actual benefit of what's going on here. What are the shortcomings that you think maybe a site quality or team competencies may have, may or may not have, but that this certification is aiming to address?

What are the things that this certification really shows? Hey, they don't have these shortcomings that you may expect from other places.

Julio Martinez-Clark: Yes, I think the issue at hand here is how do you ensure that everybody is measured with the same bar, with the same standards? That's really. Because how do you consider a good site or a bad side if there's really no framework to measure it against?

So I think that's really the major shortcoming here that is being addressed by this certification. And it's the only global certification that is being pushed by industry. Because if you look at all the advisory board, the designers of the certification and accreditation is just industry that they just want to get together and agree on a set of standards for everybody to work under the same guideline.

That's really what it is.

Etienne Nichols: So can we talk about what those actual certification requirements are? Because when I think about certifications I've gotten in the past, like my project management professional certification, for example, they require, in order for you to get that, you have to have 2,500 hours of project management X amount of years managing projects and so on.

There's additional things, you know, what are some of the sort of the pieces of criteria that, that you have to have in order to get the certification?

Julio Martinez-Clark: Yes, it's basically a framework that gets suggested to the organization, to the site to have. So the team, the assessment team will come in, will assess your documentation, your SOPs,

and will create a gap analysis,

measuring where you are against what as being agreed, that you should have. Yeah, that gap may be wide or narrow, and they create a plan for you to close that gap.

Once you close it, then you're part of the global sand. That's basically what it is.

Etienne Nichols: Yeah.

Julio Martinez-Clark: Very few. Let me, let me add something here because I think very few people know that there are a few countries around the world, Colombia being one of them. And by the way, if we're thinking about Latin America,

Colombia is the only country in the region that has a law.

Etienne Nichols: Sorry, it broke up a little bit there. Can you say that one more time? Actually, maybe we turn your video off because I think that might be taking up some of the bandwidth.

I hate to do that, but yeah.

Okay. You said something about Colombia is The only country that in Latin America that does what?

Julio Martinez-Clark: Now,

Colombia is the only country in Latin America that has mandated by law,

research, quality certification process.

a and that law was enacted in: 2008

So it's been almost 20 years. So Colombia has been very progressive in this research Excellency training because they saw that research didn't have any standards and anybody could do research in Agaram.

Yeah,

that is not really benefiting patients, not benefiting the industry. The country also recognized that pharmaceutical companies invest so much money and they needed to ensure that there was protection for this investment because they're really buying quality data.

That's really what a pharmaceutical company or medical device company is doing when they come into our country and invest in sponsoring a clinical trial. So the government was kind of visionary at that age, at that time, and set the standards.

So right now, Colombia has roughly 150 certified research sites, which is unique in Latin America. Again, let me emphasize this. Other countries,

dard that Colombia started in: 2008

this GCSA, it is really not necessary for a government to impose their own invention, their own certification,

because we're going to end up having 3,000 certifications and different standards. Right, different standards, exactly. So eventually my, my, my vision is to have Colombia join these global standards and start doing their own certification and just join the standard.

And other countries like Mexico, Copper please, and Visa in Brazil, they're all going to join these standards and they're going to just mandate to hospitals in the region. If you want to do research, you have to have a quality certification.

And GCSA is probably the best way for you to achieve that.

certification in place since: 2008

it seems like they maybe deserve a seat at the table in determining what this more broad standard is. If you want them to join. Any thoughts there or what are your comments?

Julio Martinez-Clark: That's a great point. That's a great point.

Etienne Nichols: I'm actually going to London on Sunday.

Julio Martinez-Clark: The organization in England will have an event, think tank event, and I will certainly propose this to the panel because government should be involved in the design of these or in the future of these certification standards.

Etienne Nichols: Yeah, well, can you break down the difference?

Etienne Nichols: Because I mentioned too at the beginning.

Etienne Nichols: GCSA and IA ocr, which my understanding is more individual. Can you kind of.

Julio Martinez-Clark: Yeah, yes, yes. The issue here is that as we were leaving to before we started reporting, if you are an IT person,

information technology professional, the first question that gets asked if you're applying for a job is what certification do you have? Who is validating your competency in this field? And that applies to medicine, applies to plumbing.

Etienne Nichols: Yeah.

Julio Martinez-Clark: Electricity,

many things in many fields. But exhausting applies to research where you deal with lives of patients with investigational devices and drugs which are very risky. People can die in the clinical trial.

It's just a problem that there's really no stratification for the organization that conduct clinical trials, nor to the individual that participate in the research team at a hospital.

So this certification at the organizational level and this accreditation at the individual level addresses that problem. In the industry we need to have a way to validate that a hospital is competent in research and we also need to validate that a professional is competent in the execution of clinical trial.

Etienne Nichols: Yeah, so I can go ahead.

Julio Martinez-Clark: No, he's going to take. Just to clarify. So then you have to GCSA,

site level, organization level standard certification.

You have the I, the international Accreditation Organization standard for individual that validates the competency of the individual. In other words,

there are several flavors. I mean, there is one accreditation for the investigator. There's another accreditation for the research coordinators. There's another accreditation for the site manager as an individual. So these are ways for these individuals to portray their expertise and they can take them with them to another job.

So it's just for love.

Etienne Nichols: Yeah, that makes sense. And I can definitely see the benefit. I would want people who are competent and accredited working on my project.

But I'm curious, can you talk a little bit about some of the ROI of choosing this site over that site? This one being accredited, maybe this one having a good reputation, but not necessarily having the accreditation.

Are there different ROIs that you could think that directly impact trial efficiency, risk reduction, time to market.

Etienne Nichols: Any.

Etienne Nichols: Any comments there?

Julio Martinez-Clark: Yes, yes, I've seen different numbers, different stats. Certainly the ROI is there. I don't have the numbers off top of my head,

but I've seen the presentations, I've seen the documentation and sites report higher patient engagement, higher recruitment rates,

higher number of trial opportunities because they are put in a different category in the databases of big Pharma. So if I am a CRO or I'm a big pharma company.

I want to have a different hierarchy where I can have certified sites first. Those are going to be my first choice when I'm looking to conduct a study.

Then the second tier will be sites without reception that I will contact if the first tier is not suitable for my study. So I think we're going to see the creation of these tiers and you're going to be put on the top of the list if you are certified and you're going to be put on the top of the list of for employment if you are accredited as an individual.

Etienne Nichols: Yeah, that makes sense. How do you find one of these? Is it to go to the GCS GCSA website or.

Julio Martinez-Clark: Yes, yeah, yes, exactly. There is a global database of certified sites and also accredited individuals where sponsors and CROs going to be able to to look and try to find those sites.

The larger shadows are already doing this. I mean they are the ones promoting this certification. And a query page. They already know who they are.

Etienne Nichols: Yeah, okay.

Julio Martinez-Clark: And every time there's a new one, there is a lot of marketing on LinkedIn and social media.

So everybody will know who they are. And actually in the new website we put a map, the website that we just launched for the Americas, we put a map where you can see exactly where they are and they're going to be starting to pop up very soon.

We are in advanced conversations with one of the leading hospitals in Latin America, in Colombia, by the way, affiliated with Mayo Clinic, which is the second hospital in Latin America affiliated with Mayo Clinic.

And the announcement will happen on May 28 and this hospital will probably be the first GCSA certified site in Latin America. And that will create a domino effect because everybody else will also want to be part of the certification process.

Etienne Nichols: Yeah, that sounds intriguing. So what do you see the future of clinical trial certification heading? You mentioned Columbia and their history with their certification. And you mentioned going to London. Do you see things changing even more or what's the future look like?

Julio Martinez-Clark: Well, the Colombian situation that I described initially, where you have a obligation to certify your site through the Ministry of Health in Colombia creates an opportunity for DCSA to come into Colombia first because sites are already accustomed to these certification, they know they need to be certified.

This is GCISA is adding another layer to the already existing certification that is going to put them in the global map. Because right now the Colombian certification is just local.

Nobody else knows about it. But this GCSA certification is a cherry in the pie for these sites. They are an easy,

we're having very easy conversations with these sites in Colombia because they already see the value of being certified,

whereas in Mexico, in Brazil, Argentina, this is not a common thing. So it's a harder conversation. It's a.

Etienne Nichols: So, so you're saying Columbia, it makes sense because they've already, they have a certification, these other companies. Maybe it's not as a standardized thing yet. So but with Columbia, I would also expect that it's, it's an easy transition.

Like maybe they already have a standard or they already have a certification, they're going to go to this global standard. There's not a lot of additional work. Is that accurate and how you would, how would you describe other countries effort?

Etienne Nichols: 100% accurate. 100%. And also, I think there is also a trend in the different regulatory bodies in Latin America following Colombia's example, because the number of trials that are coming to the region is increasing and the agencies are looking for ways to ensure quality and safety, patient safety, of course,

in these trials. So instead of coming up with their own certification, they can take Columbia's example and look at global certifications for quality research.

So I envision that a lot of governments will embrace the GCSA certification. I'm actually going to give a talk in a couple weeks in the National Research Clinical Research event that happens in Mexico every year around May that is being sponsored by the Mexican association of Clinical Research Professionals.

And they loved the.

Actually the topic of the event coincidentally was or is it's going to happen in May 23rd. I think the topic of the event is quality in clinical research. So it was very timely.

Yes, it was very timely when I saw that and I wrote to the president of the association because Miriam Serrano, she's my friend and I told her, listen, I am involved with gcsa.

What a coincidence that the topic of your event is quality research. And I have something for you. And she invited me to give a talk and I think her intention is to have the industry and more specifically, she told me, I want CofE pri pri, which is the national regulatory agency in Mexico,

to hear what you have to say about gcsa because we don't want them to impose their own certification. We want them to embrace a global certification.

Etienne Nichols: Yes, the harmonization makes so much sense because I can almost see it from a country ROI standpoint. If sponsor is coming to a country and saying, well, okay, I don't really want to use this site because they have their own little specific certification, it's just easier for us to look at something that's standard across the board.

We can plug into this hospital. Plug into this hospital. Yeah. There seems like there's an ROI there to make, to just get on board with a global certification.

Etienne Nichols: Absolutely, absolutely. And also, I think. I think it's worth mentioning that, that when I said that the number of trials in Latin America is incre increasing. The countries are maturing at a fast pace.

The hospital infrastructure is getting better and better.

onths back towards the end of: 2024

just launched an operation in Latin America. They started an office in Brazil and the goal is to. According to their press release, the goal is to start buying sites in Brazil, Mexico, Argentina and Colombia, which are the top countries for researching Latin America.

Yeah, but that will push a lot of processes, insights and quality, et cetera.

Julio Martinez-Clark: Et cetera, et cetera. I mean, higher standards.

Etienne Nichols: Yeah.

So we talked a lot about the certification. I know you're plugged in because you already mentioned Argentina, Colombia, Brazil. You're plugged into a lot of these different countries. Maybe just to kind of wrap this up, I'd love to give a quick lightning round synopsis of just a few pros and cons.

I mean, it probably deserves its own method, its own podcast episode. Maybe we can do that in the future. But yeah, just when you're talking to all these different companies and you talk to all these different people in different countries,

what are some of the pros and cons of going this country versus that country? And. And because you're such a proponent for Latin America, and I love that. What are your thoughts here?

Etienne Nichols: Yes,

if you are a sponsor and you're looking for speed,

you're going to be better served in a smaller country. That's kind of the way it works in the region. So countries like Panama, El Salvador, Honduras,

Dominican Republic, you can get your sites activated in less than 60 days, which is fantastic. Very competitive.

Etienne Nichols: Yeah.

Etienne Nichols: And if you're looking for a larger pool for patient recruitment, larger patient pool, larger population, then you have to move to, of course, a country like Mexico, Brazil, Argentina or Colombia.

But you compromise seat.

Right. So there's.

It's either this or that.

Julio Martinez-Clark: Yeah, there are a few.

Etienne Nichols: Only a few countries already in the middle, like Chile. Chile is kind of in the middle because it has a fairly decent population, 20 million people, and a fairly good regulatory approval process or timeline for approval.

But Brazil, it will take longer. I mean, many months. Same with coffee pries in Mexico, it will take many Months. But once you get approved, once you have the site activated, I mean, the patient recruitment potential is immense.

The other thing that you also have to consider as a sponsor is the way the healthcare system works in each country. For example, in Mexico there are five different healthcare systems, believe it or not.

So it's very difficult to navigate those healthcare systems because there's one system for school teachers, there's another system for the military, there's another system for government employees, there is another system for low income people,

and then you have the private system, et cetera. So you have different databases, different hospitals. So it gets a little complicated.

Julio Martinez-Clark: So you really have to be smart.

Etienne Nichols: On what site to activate and what part of the system that site is plugged in so that you can ensure patient recruitment. So there's really no perfect country. It really depends on what you're looking for.

If you're looking for speed, as I said, you go for a smaller countries. If you're looking for a larger patient pool, you go to a larger country like Brazil, Mexico, Colombia, Argentina.

But you have to wait a little longer to get approval and the red tape is higher than in smaller countries.

Etienne Nichols: That makes sense. Well, I know I've taken, we've gone in a lot of different directions and I really am intrigued by the future of the certification process and how that's going to affect just clinical trials in general in Latin America.

But any last, just kind of, as we wrap up here, any last pieces of recommendation or suggestions to those listening?

Etienne Nichols: Yes, the recent news suggests that the situation at the FDA will continue to get worse because of the layoffs and the way this new government in the United States is approaching the FDA matters.

I've been talking to colleagues in the industry and everybody is very negative about the future of the approval process in the United States. It just gets delayed and delayed. It's just.

For example, the other day somebody was telling me that they are not even able to get pre submission meetings with fda. I mean, it's difficult to get them on the schedule.

So I think the trend will be to start for these companies, for a lot of US companies, start looking at Latin America as a place to do more trials and, or to start commercializing innovations because getting approval in Europe is difficult with the new EU ndr, getting approvals in the United States is going to be very certain certainly in the next three,

four years with this government. So I think companies will look at Brazil, Mexico, Colombia as places where they can start selling before they sell in the United States.

Etienne Nichols: That's interesting.

Etienne Nichols: Or to do trials as well.

Etienne Nichols: I'd be interested to hear more about that in the future as this develops a little bit, because I can almost see, I mean, there's already a bit of medical tourism that goes on and if a lot of innovation is now being sent primarily or first to Latin America, what's that going to be like for the future?

Yeah,

you got the wheels turning here.

Very cool. Interesting. Well, keep us, keep us informed as this, as this progresses. It's always, you know, it's discouraging what's happening at the fda, particularly if things are going to slow down.

And, you know, for the longest time in the last 10 years, this pendulum has swung to where the FDA was the primary first to market for a lot of companies.

Whereas it used to be Europe when I. Early in my career.

Etienne Nichols: Yes, yes. Same with me. Early in my career it was Europe first, then the United States. But now I don't know what's going to happen. Probably Latin America first, hopefully, who knows?

Etienne Nichols: Something I wasn't expecting, but it's interesting and I can't wait to see, you know, one way or another. There's always a silver lining. Depending on who I talk to, I change my phrase.

I say there's a silver lining for every dark cloud. But some people who are just excited about all the future, I'm like, yeah, well, for every silver lining there is a dark cloud.

I think sometimes you need to remember that. But anyway, keep us informed. Where can people go to learn more about you? Learn about this certification process or any, any place you want to point the audience.

Etienne Nichols: I think the best place is LinkedIn. I'm very active on the platform. I have over 30,000 followers and I. Mega poster.

Etienne Nichols: I would agree with that. Yeah, go on.

Etienne Nichols: Yes. Yeah, so just look for Julio Martinez Clark on LinkedIn and you're going to find everything about me, about BioAccess Latin America. I write a column on Medivice Online that is linked to my LinkedIn profile.

I also have my podcast where I talk about these topics. It's also linked in my LinkedIn profile. And I also have our website, bioaccessla.com, also linked to my profile.

Etienne Nichols: Okay, well, we'll put links of those in all of the. In the show notes so that people can find you and reach out. And thank you so much. I appreciate you sharing your expertise and I hope it goes well in London and we'll.

Hopefully we can be back in touch in the next few months and see how things have developed. But really appreciate it. Those of you who've been listening. Thank you so much for listening to the Global Medical Device Podcast.

We will see you all next time. Take care.

Etienne Nichols: Thanks for tuning in to the Global Medical Device Podcast. If you found value in today's conversation, please take a moment to rate, review and subscribe on your favorite podcast platform.

Etienne Nichols: If you've got thoughts or questions, we'd.

Etienne Nichols: Love to hear from you. Email us@podcastreenlight.guru. stay connected for more insights into the future of medtech innovation. And if you're ready to take your product development to the next level, Visit us at www.greenlight.guru.

until next time, keep innovating and improving the quality of life.