Category: Challenges and Solutions for Medtech Startups

If you typed CREOS into a search box, you are probably building a CRO shortlist. This article uses only what CREOS publishes (www.creoscro.com) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What CREOS publishes

CREOS is a Buenos Aires CRO offering "solutions in clinical research to the pharmaceutical, biotechnology and medical devices industry": Phase I–III, bioequivalence, adaptive, basket and umbrella designs, and real-world evidence. Its co-founders are Daniel Livio, MD, and Néstor Flaster, MD, a former ANMAT evaluator.

CREOS vs bioaccess®

Dimension	CREOS	bioaccess®
Core focus	Argentine drug / RWE CRO with devices listed	First-in-human and early feasibility studies for medical devices
Geography	Buenos Aires HQ; works across Latin America with local experts in each country	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	Phase IV / real-world studies and a full pharmacovigilance service, including post-marketing	Live multi-country sanitary registration and in-country holder service

Where each one fits

If the study is an Argentine Phase II–III, a bioequivalence study or a real-world evidence project, CREOS fits the brief.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including CREOS, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

Ready to compare a proposal? Request a first-in-human study proposal.

Competitor facts from the CREOS public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.

If you typed Avanti Pesquisa Clínica into a search box, you are probably building a CRO shortlist. This article uses only what Avanti Pesquisa Clínica publishes (avantipc.com.br/en) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What Avanti Pesquisa Clínica publishes

Avanti Pesquisa Clínica is a São Paulo ARO/CRO that serves pharmaceutical, biotechnology, biosimilar and medical device companies across Phases I–IV, with clinical supplies and device storage among its services. We found no named device study on its site.

Avanti Pesquisa Clínica vs bioaccess®

Dimension	Avanti Pesquisa Clínica	bioaccess®
Core focus	Brazil ARO/CRO + clinical supplies	First-in-human and early feasibility studies for medical devices
Geography	Brazil (São Paulo); describes itself as a Latin American ARO	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	See provider site	Live multi-country sanitary registration and in-country holder service

Where each one fits

If you need a Brazilian partner for study execution plus clinical-supply logistics, Avanti covers both.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including Avanti Pesquisa Clínica, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

Ready to compare a proposal? Request a first-in-human study proposal.

Competitor facts from the Avanti Pesquisa Clínica public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.

If you typed Azidus (AZD CRO) into a search box, you are probably building a CRO shortlist. This article uses only what Azidus (AZD CRO) publishes (azidusbrasil.com.br) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What Azidus (AZD CRO) publishes

Azidus Brasil (AZD CRO) is based in Valinhos, São Paulo state, and cites 25 years of experience, with partnerships it lists in Argentina, Colombia, Uruguay, Mexico, Canada and the US. It offers First in Human, proof-of-concept and Phase I work, and its solutions cover health products alongside synthetics, biologics, cell therapy, vaccines, cosmetics and food. Dra. Luciana Ferrara is CEO. Its client list is mostly pharma.

Azidus (AZD CRO) vs bioaccess®

Dimension	Azidus (AZD CRO)	bioaccess®
Core focus	Brazil early-phase CRO, drug and health products	First-in-human and early feasibility studies for medical devices
Geography	Brazil (Valinhos, SP); partnerships in Argentina, Colombia, Uruguay, Mexico, Canada and the US	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	Product registration support (its homepage pairs clinical studies with product registration)	Live multi-country sanitary registration and in-country holder service

Where each one fits

If you need Brazilian Phase I or proof-of-concept for a drug, biologic or cosmetic, Azidus is built for that.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including Azidus (AZD CRO), for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

Ready to compare a proposal? Request a first-in-human study proposal.

Competitor facts from the Azidus (AZD CRO) public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.

If you typed Intrials into a search box, you are probably building a CRO shortlist. This article uses only what Intrials publishes (intrials.com.br) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What Intrials publishes

Intrials is a São Paulo CRO founded in 1999, operating in Brazil, Argentina, Chile, Colombia, Mexico and Peru. It runs Phase I–IV with core areas in oncology, infectious disease and vaccines, rare disease, immunology, cardiology, dermatology and respiratory, and a Medidata partner listing includes devices and diagnostics. Sergio Braga Filho is President and CEO. We found no named device first-in-human study.

Intrials vs bioaccess®

Dimension	Intrials	bioaccess®
Core focus	Homegrown full-service LATAM CRO, drug-primary	First-in-human and early feasibility studies for medical devices
Geography	Latin America (its homepage cites 25+ years in the region and 550+ studies)	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	See provider site	Live multi-country sanitary registration and in-country holder service

Where each one fits

If the program is a multi-country Phase II–III drug or late-phase study across South America and Mexico, Intrials is a strong homegrown option.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including Intrials, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

Ready to compare a proposal? Request a first-in-human study proposal.

Competitor facts from the Intrials public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.

If you typed CORVIA CRO / Elemental consortium into a search box, you are probably building a CRO shortlist. This article uses only what CORVIA CRO / Elemental consortium publishes (elemental.org.mx/cro · elemental.org.mx/consorcio) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What CORVIA CRO / Elemental consortium publishes

Elemental is a Mexican consortium whose CRO page offers services for pharmaceuticals, biotech products, supplements and medical devices. Its consortium sites include CECyPE in Morelia, IDEAS / IDeCSa in Mexico City, CIMET in Guadalajara and FScientia in San Luis Potosí. It also lists prototype development and medical-device protocol design. We found no named device first-in-human study.

CORVIA CRO / Elemental consortium vs bioaccess®

Dimension	CORVIA CRO / Elemental consortium	bioaccess®
Core focus	Mexican site consortium + CRO across product classes	First-in-human and early feasibility studies for medical devices
Geography	Mexico (CRO based in Mexico)	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	Regulatory advice (COFEPRIS, ANVISA, FDA, NMPA), pharmacovigilance and Phase IV / real-world studies	Live multi-country sanitary registration and in-country holder service

Where each one fits

If you want Mexican site capacity across several cities and a group that also helps with prototype development, Elemental is worth a call.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including CORVIA CRO / Elemental consortium, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

Ready to compare a proposal? Request a first-in-human study proposal.

Competitor facts from the CORVIA CRO / Elemental consortium public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.

If you typed Infinite Clinical Research (WEAREINFINITE) into a search box, you are probably building a CRO shortlist. This article uses only what Infinite Clinical Research (WEAREINFINITE) publishes (weareinfinite.mx) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What Infinite Clinical Research (WEAREINFINITE) publishes

Infinite Clinical Research (WEAREINFINITE) is a Mexico City CRO that calls itself "100% Mexican" and full-service, and is a founding member of ACROM. It publishes a research protocols and medical devices service, COFEPRIS device registrations and technovigilance. We found no named device protocol or sponsor on its site.

Infinite Clinical Research (WEAREINFINITE) vs bioaccess®

Dimension	Infinite Clinical Research (WEAREINFINITE)	bioaccess®
Core focus	Mexico full-service CRO with device protocols and COFEPRIS	First-in-human and early feasibility studies for medical devices
Geography	Mexico City HQ; lists operations in Mexico, Argentina, Chile, Colombia, Costa Rica, Guatemala, Panama, Dominican Republic and El Salvador, among others	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	COFEPRIS sanitary registration for medicines and devices, import logistics, pharmacovigilance and technovigilance	Live multi-country sanitary registration and in-country holder service

Where each one fits

If Mexico is the only country and you want one local firm for the protocol and the COFEPRIS registration, Infinite publishes both.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including Infinite Clinical Research (WEAREINFINITE), for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

Ready to compare a proposal? Request a first-in-human study proposal.

Competitor facts from the Infinite Clinical Research (WEAREINFINITE) public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.

If you typed MSC MED into a search box, you are probably building a CRO shortlist. This article uses only what MSC MED publishes (www.mscmed.com.br/en) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What MSC MED publishes

MSC MED (MSc Med Engenharia e Tecnologia Médica Ltda.) is a Brazilian CRO headquartered in Florianópolis with a commercial office in Curitiba. It describes itself as a CRO specializing in safety and efficacy demonstration and international regulation of medical devices. Services include clinical evaluation (ISO / ANVISA), biocompatibility, MRI compatibility and registration hosting. Heitor Korndorfer is founder and CEO.

MSC MED vs bioaccess®

Dimension	MSC MED	bioaccess®
Core focus	Device clinical evaluation, testing and Brazil regulatory	First-in-human and early feasibility studies for medical devices
Geography	Brazil (Florianópolis HQ, Curitiba office); says it has served companies from over 15 countries	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	Brazil registration hosting and ANVISA / FDA regulatory support	Live multi-country sanitary registration and in-country holder service

Where each one fits

If the job is clinical evaluation, biocompatibility or MRI-compatibility work, or a Brazil registration, MSC MED is built for it.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including MSC MED, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

Ready to compare a proposal? Request a first-in-human study proposal.

Competitor facts from the MSC MED public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.

If you typed Zenter Research into a search box, you are probably building a CRO shortlist. This article uses only what Zenter Research publishes (zenterresearch.com) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What Zenter Research publishes

Zenter Research S.A. is an Argentine CRO in the San Isidro / Buenos Aires area, founded by Victor Molina Viamonte, MD FACC, its CEO and CSO. Its public materials describe cardiovascular "Pharmaceutical & Devices" work, clinical and medical monitoring of pharmaceutical and device trials, and "First Time in Man" Phase I studies, with FDA audits it cites in 2014 and 2019. The device work it describes is cardiovascular Phase II–III megatrials, not a named early feasibility study.

Zenter Research vs bioaccess®

Dimension	Zenter Research	bioaccess®
Core focus	Drug-primary cardiovascular CRO with device monitoring and Phase I	First-in-human and early feasibility studies for medical devices
Geography	Argentina; offers legal representation before ANMAT for sponsors outside Argentina	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	See provider site	Live multi-country sanitary registration and in-country holder service

Where each one fits

If the program is a cardiovascular drug or a large Phase II–III device trial centered in Argentina, Zenter is a credible local option.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including Zenter Research, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

Ready to compare a proposal? Request a first-in-human study proposal.

Competitor facts from the Zenter Research public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.

ACTIVA CRO is the Argentine regional full-service house that keeps showing up when a U.S. founder types ACTIVA CRO, LATAM CRO Argentina, or Latin America full-service CRO. The firm is real. The website is live. The product is not a boutique first-in-human implant franchise, even though “First in Human” and “Pivotal studies in Medical Devices” sit on the company page.

bioaccess® already publishes a comparison page at bioaccessla.com/compare/activa-cro. Do not treat this article as a second grid of the same claims. This is the public-record piece: what activa-cro.com actually says (retrieved 23 August 2026), what ISO 9001 in 2006 does and does not prove, and when a U.S. device FIH should hire a specialist instead of a southern-cone full-service engine.

No named device sponsors appear on the public site. We will not invent any.

What ACTIVA CRO publishes

The homepage and company page describe ACTIVA CRO as a full-service Contract Research Organization with operations in Latin America, serving CRO, biotech, pharmaceutical, and medical-device clients. Founded in 2003, it “rapidly expanded to Argentina, Chile, Uruguay, Brazil, Peru, Mexico, and Colombia” and calls itself a “southern cone” provider. A 2008 timeline item says the firm was “shaped as a Regional CRO,” then added Panama, Costa Rica, and Ecuador. The FAQ country list is Argentina, Uruguay, Chile, Brazil, Colombia, Mexico, Peru, Ecuador, Costa Rica, and Panama.

The home page publishes a mix graphic: 34% CRO, 32% pharmaceutical, 17% biotech, 17% medical-device industry. Those are company-published percentages, not an audited book of business we have seen. Read them as marketing mix, not as a diligence finding.

The company page says ACTIVA brings experience “in all Clinical trial phases and major therapeutic indications, including Oncology, Hematology, Cardiovascular, Orphan Diseases, CNS, First in Human, and Pivotal studies in Medical Devices,” with senior project managers that “bring an average of 10 years of experience” — their claim. Services listed: medical affairs, regulatory affairs, project monitoring, legal sponsor representation, clinical project oversight, investigator contract negotiation, feasibility, inspection readiness, start-up, clinical staffing, and quality assurance.

Public managers on the company page: Gabriel Desanto, Clinical Operations Director; Mariano Monteagudo, Business Development Director. Founders are described as senior ClinOps / RA professionals; individual founder names are not on the company page fetched for this article.

ISO 9001. The FAQ, live 23 August 2026, states: in 2006, Activa-CRO (South American) was granted ISO 9001:2000 certification on “Control and surveillance on clinical research trial processes for the development of drugs, biological products and medical devices,” recertified ISO 9001:2008, issued by Bureau Veritas and accredited by UKAS, ANAB, and OAA. That is a 2006 quality-system credential that explicitly includes medical devices. It is not a named implant EFS. It is not current-year ISO 9001:2015 evidence unless the firm shows a later certificate. Ask for the current certificate in the RFP.

The homepage has a “customers” block. The fetch did not yield named device-sponsor logos as text. No named device protocol or sponsor is treated as a fact in this article.

Where a regional LATAM full-service CRO is the right tool

Hire ACTIVA when the protocol is a multi-country Latin American program across phases — oncology, hematology, CNS, rare disease, or a later-phase device — and you want one southern-cone vendor that will also be legal sponsor representative, negotiate investigator contracts, and staff monitors. That is a real product. The compare page already says so: if you need Phase I–IV devices and pharma under one regional roof, ACTIVA is in-category.

Do not assume “First in Human” plus “Pivotal studies in Medical Devices” on a capabilities paragraph equals a U.S. startup’s first five-to-thirty implants designed from a Pre-Sub. Full-service regional CROs list FIH because they will take the work. Specialist FIH CROs list FIH because that is the only work. The diligence question is the TMF, not the bullet.

The product a U.S. device FIH actually buys

A U.S. medtech FIH/EFS implant study is a different product from a LATAM full-service Phase II–III:

• The article is a device, often an implant or delivery system, under ISO 14155, not only ICH E6.
• The customer for the package is FDA (Pre-Sub, IDE, 21 CFR 812.28), not only ANMAT or INVIMA.
• Import, sterilization, device accountability, and procedure-room source data dominate start-up.
• n is small. Staffing must not look like a regional pharma engine.
• The operating language and headquarters the CEO will call are usually English and U.S. Eastern Time.

bioaccess® is built as that product. Co-founded 2010 by Dr. Pedro Martinez-Clark, Dr. William O’Neill, and Julio G. Martinez-Clark. IMH ASSETS CORP. Miami headquarters. Regional offices in Bogotá, Mexico City, Santiago, São Paulo, and Buenos Aires — Argentina is already an execution geography. FIH-only since 2010. 50+ pre-qualified sites, 19 countries; 50+ FIH/EFS supported; 50+ clients (about page).

In Colombia, bioaccess® still runs trials (23 August 2026), keeps a local entity and office, manages INVIMA clocks in-country, and has 30+ historical FIH device studies and 20+ sites in Bogotá, Cali, Medellín, and Barranquilla. bioaccess® runs first-in-human studies in Colombia now. See CRO in Colombia. Commercial registro sanitario is a separate live service, including ANMAT.

ACTIVA CRO vs bioaccess® — device FIH comparison

Dimension	ACTIVA CRO	bioaccess®
Home country	Argentina-origin regional CRO (2003)	United States HQ (Miami); local LATAM entities including Colombia and Argentina office
Published mix	Company graphic: 34% CRO / 32% pharma / 17% biotech / 17% device	FIH/EFS is the core offer
FIH / device language	First in Human and pivotal medical-device studies claimed on the company page	Device FIH/EFS specialist since 2010
Named device EFS / sponsors	None on public site	Published case studies on bioaccessla.com
Quality claim	ISO 9001:2000 granted 2006 for control/surveillance of drug, biologic, and device trials; recertified 9001:2008 (FAQ)	ISO 14155 device investigations; 812.28-ready English data room
Leadership (site)	Gabriel Desanto (ClinOps); Mariano Monteagudo (BD)	Julio G. Martinez-Clark, CEO; Pedro Martinez-Clark, CMO; William O’Neill
Footprint	AR, UY, CL, BR, CO, MX, PE, EC, CR, PA (FAQ)	19 countries; 50+ pre-qualified sites
After the trial	Full-service clinical + RA / legal sponsor representation	Live multi-country sanitary registration / in-country holder

How to keep ACTIVA on the list without confusing the job

If the protocol is a regional LATAM pivotal or a multi-country pharma/device program and Argentina is the operating center of gravity, ACTIVA is in-category. If the protocol is a first implant for a U.S. device company, put ACTIVA in the “regional full-service / possible later-phase or local partner” column and put bioaccess® in the “prime FIH CRO” column. Then ask ACTIVA for a named or de-identified device EFS: class, implant versus non-implant, n, ISO 14155 monitoring plan, English TMF, and FDA-file use. If that package exists, the two firms can split work — FIH with the specialist, later phase with the regional house. The compare page already contemplates that handoff.

Argentine and regional peers already covered: LAT Research, RARAS, Cohortias. Panama specialist: First in Humans. Request a proposal at contact.

FAQ — ACTIVA CRO and device FIH

Is ACTIVA CRO a first-in-human CRO?

It lists First in Human among phases and indications, next to oncology, hematology, CNS, and pivotal medical-device studies. That is a full-service menu. It is not a published implant case series.

Does ACTIVA have ISO 9001?

The live FAQ says ISO 9001:2000 was granted in 2006 for control and surveillance of drug, biologic, and medical-device trial processes, recertified ISO 9001:2008. Ask for the current certificate. Do not treat a 2006 grant as a 2026 named EFS.

Who leads ACTIVA?

The company page names Gabriel Desanto (Clinical Operations Director) and Mariano Monteagudo (Business Development Director).

Is bioaccess® a direct competitor?

Only in a narrow slice — the first-in-human device (and FIH biopharma/radiopharma) job. For Phase II–IV regional coverage, ACTIVA is often the better fit. See the compare page.

Does bioaccess® still run studies in Colombia?

Yes. Local Colombian entity and office, INVIMA clocks in-country, commercial registro sanitario as a separate live service.

Competitor facts from activa-cro.com, /company/, and /faq/, 23 August 2026. bioaccess® facts from bioaccessla.com. No invented emails, sponsor names, or day-count medians. ACTIVA mix percentages and “average of 10 years” are their company claims.

Cohortias International brands itself “the CRO of LATAM” and publishes a dedicated medical-device page plus an early-phase platform aimed at startups and implantable devices. For a U.S. founder shopping Mexico, that combination will surface in every “CRO Mexico FIH” search. It is a real competitor. It is also a different product from a first-in-human CRO that anchors the study to FDA from Miami, executes through its own Colombian entity and its local partners in other countries, and then holds sanitary registrations after the trial.

This comparison uses only what Cohortias publishes on cohortias.com, medical devices, and early-phase trials as of 23 August 2026, plus the ACROM member listing for the legal name. Company slogans and headline counts are labeled as claims.

What Cohortias publishes

The home page titles the firm for “Clinical Trials in Mexico and LATAM” and offers trials in Mexico, Argentina, Colombia, and Brazil. The company calls itself “Locally-Based, Full-Service CRO in Latin America” and, repeatedly, “the CRO of LATAM.” Another home-page line says “As the largest South American Contract research Organization” — treat that as a company claim, not a verified ranking. A “20+ Years of Experience” block is likewise a company claim; the public pages reviewed do not attach a founding year or a named first study to that figure.

The ACROM (Mexican CRO association) contact list identifies the legal vehicle as Cohortias International SAPI de CV. Competitive maps place the HQ at Blvd. Manuel Ávila Camacho 36, Piso 12, Miguel Hidalgo, Mexico City 11000, with additional published office geographies of Monterrey, São Paulo, Bogotá, and Olivos / Buenos Aires. The home page states services are provided with offices in Argentina, Brazil, Colombia, and Mexico.

Named leadership on the home page: Salvador Velasco, Chief Executive Officer; Oscar Luviano, Chief Financial Officer; Gabriela Rosas, Clinical Operations Director; Pedro Alvarez, Business Development Manager. No named sponsors, device brands, or protocol titles appear on the pages reviewed.

Service tiles that matter for MedTech:

• Early Phase Trials — “First-in-Human Studies. Get to patients faster, no IND necessary. Valid data for FDA submission.”
• Medical Devices — “A fast-track platform”; “Pilot and Pivotal Device Studies”; shipping through data collection.
• Rescue studies and Phase II/III — full-service outsourcing, “more than 300 sites available” on the rescue tile (company claim), local regulatory experts.

The early-phase page is the most specific public description of the FIH product. Cohortias describes a platform of small 1–2 site trials in patients with safety and efficacy endpoints (sometimes dose-escalation), 10–30 patient studies, designed to get to patients without an IND, with data the page says can later be used in the United States. Approvals are described as going through three Mexican bodies: IRB, UHAP, and COFEPRIS, under GCP / ICH, with a DSMB-heavy safety design. The intended customer is “small/mid size startup biotech/pharma/device companies,” including “riskier areas and exploratory ideas (neurosciences, implantable devices, etc.).” Locations named for those trials: Monterrey and Mexico City. Advantages listed on that page include skipping “1 Year / $2M – $4M USD” of U.S. spend to reach patients — Cohortias’ own cost framing, not a bioaccess® figure.

The medical-device page describes a feasibility platform (strategy / protocol / risk-based plan; monitoring, data, vendors, safety; close-out, lock, analysis) and positions Cohortias as “a full-service medical device CRO” with Latin American infrastructure “for a fraction of the cost compared to the US medical device CRO market.” Therapeutic areas listed on the home page include ophthalmology, diabetes/metabolic, infectious disease, cardiovascular, neurology, respiratory, and oncology.

Home-page counters (patients in network, conducted studies, lost-to-follow-up) did not render as stable numbers in the text extract used for this article; they are not repeated here as facts.

Where the Cohortias product fits

Cohortias is a Mexico-headquartered full-service CRO with an explicit early-phase, 10–30 patient, 1–2 site, implant-friendly platform in Monterrey and CDMX, plus a four-country office list. That is a legitimate Mexico FIH option for a sponsor whose regulatory center of gravity is COFEPRIS and whose U.S. strategy is already staffed elsewhere.

Three gaps show up the moment the job is a U.S. company’s first implant for an FDA file, not a Mexico early-phase experiment:

1. No named device, protocol, or sponsor on the public site. The early-phase platform is well specified as a design. It is not evidenced as a completed, named EFS.
2. The FDA story is “no IND / valid data for FDA submission.” For devices the relevant U.S. constructs are more often Pre-Sub / Q-Sub, IDE, EFS under 21 CFR 812.28, and an English ISO 14155 TMF — not the IND exemption language that reads as drug-first. A sponsor still needs a U.S. regulatory author in the room.
3. Mexico-pair geography vs. regional LATAM. Offices in four countries are not the same as a prime CRO that already runs Colombia with its own entity, manages INVIMA clocks in-country, and can hold registro sanitario after the trial. A CDMX/Monterrey platform is a country product. A first-in-human LATAM CRO is a regional product with a Miami desk.

What bioaccess® is instead

bioaccess® is The First-in-Human CRO — U.S. regulatory anchoring plus Latin American execution. Co-founded in 2010 by Dr. Pedro Martinez-Clark, Dr. William O’Neill, and Julio G. Martinez-Clark (CEO). IMH ASSETS CORP. Headquarters: 1200 Brickell Ave, Suite 1950 #1034, Miami, FL 33131. Regional offices include Mexico City as well as Bogotá, Santiago, São Paulo, and Buenos Aires. FIH-only focus since 2010. ISO 14155 for devices; ICH E6 for drugs. Pre-Sub / IDE planning and an 812.28-ready English data room are part of the published offer, not an after-the-fact translation. 50+ pre-qualified sites across 19 countries; 50+ FIH/EFS studies supported; 50+ clients (about page).

Colombia remains an operating country: bioaccess® still runs clinical trials there, keeps a local Colombian entity and office, manages INVIMA clocks in-country, and has 30+ historical FIH device studies and 20+ sites in Bogotá, Cali, Medellín, and Barranquilla. INVIMA is PAHO/WHO Level 4. Commercial registration is a separate live service, including COFEPRIS and INVIMA. Read CRO in Colombia and CRO en Colombia.

If the sponsor wants Mexico plus Colombia, or Mexico plus a second country, one prime with local entities is the cleaner MSA. That is the structural offer. Cohortias can still be a Mexico site-access or rescue partner. It should not be confused with the FIH operating system.

Cohortias vs bioaccess® — FIH device comparison

Dimension	Cohortias International	bioaccess®
Legal / brand (public)	Cohortias International SAPI de CV (ACROM); “The CRO of LATAM”	bioaccess® (IMH ASSETS CORP.)
HQ	Mexico City (published / ACROM maps)	Miami, Florida; Mexico City is a regional office
Leadership (public)	Salvador Velasco, CEO; Oscar Luviano, CFO; Gabriela Rosas, ClinOps; Pedro Alvarez, BD	Julio G. Martinez-Clark, CEO; Pedro Martinez-Clark, CMO; William O’Neill, Medical Director
Early-phase device model	1–2 sites, 10–30 patients, Monterrey & CDMX; IRB + UHAP + COFEPRIS	Small-n FIH/EFS across a 19-country pre-qualified network; ISO 14155 architecture
FDA language on site	“No IND necessary”; “valid data for FDA submission”	Pre-Sub / Q-Sub, IDE/IND, 21 CFR 812.28-ready English data room
Named sponsors / named device EFS	None on public site	30+ historical FIH device studies; case studies on bioaccessla.com
Scale claims	“Largest South American CRO”; “20+ years” — company claims	Founded 2010; ~16 years; 50+ clients / 50+ FIH-EFS / 50+ sites (about page)
Colombia	Office listed among AR/BR/CO/MX	Local entity + office; trials since 2010 and still running; INVIMA in-country
Commercial registration	Not the published product	Live LATAM registro sanitario / in-country holder

Diligence questions for a Mexico FIH device RFP

1. Ask for a de-identified implant EFS: indication, n, sites (Monterrey vs. CDMX), whether UHAP + COFEPRIS + IRB all closed, and whether an English TMF was delivered to a U.S. file.
2. Ask who writes the Pre-Sub or IDE strategy. “No IND” is not an IDE strategy.
3. Ask who the Mexican legal representative and importer of record are, and whether they are Cohortias or a third party.
4. Ask what happens if the funnel fails in Mexico and the protocol must add Colombia or Panama. A four-country brochure is not a second-country start-up plan.
5. Ask who holds COFEPRIS / INVIMA sanitary registration after the trial if the device will be sold.

bioaccess® answers those items from a published model: Miami FDA desk, Mexico City and Bogotá offices, local entities, FIH-only focus since 2010, and a live market-access subscription. Start the conversation at bioaccessla.com/contact.

FAQ — Cohortias CRO LATAM and device FIH

Is Cohortias a first-in-human CRO?

It publishes an early-phase platform that includes first-in-human studies and implantable devices, sized at 1–2 sites and 10–30 patients in Monterrey and Mexico City. It does not publish a named FIH device case on the pages reviewed.

Does Cohortias work in Colombia?

Colombia is on the published office and country list. Depth of a Colombian legal entity, INVIMA device FIH track record, and named Colombian sites are not on those pages. bioaccess®’s Colombia practice is the documented local-entity FIH option — see CRO in Colombia.

Is Cohortias the largest CRO in South America?

That is a company slogan on the home page. It is not treated as a verified ranking here.

When is bioaccess® the better prime for a U.S. implant?

When the study must be FDA-facing from protocol authoring, may need more than Mexico, should run through the CRO’s own Colombian entity and its local partners in other countries, and may continue into sanitary registration with the same partner. See First-in-Human CRO and market access.

Does bioaccess® still run trials in Colombia?

Yes. Local Colombian entity and office, INVIMA clocks managed in-country, commercial registro sanitario as a separate live service. bioaccess® runs first-in-human studies in Colombia now.

Competitor facts from cohortias.com (home, medical-devices, early-phase-trials) and the ACROM member listing, 23 August 2026. bioaccess® facts from bioaccessla.com. No invented emails, sponsor names, or day-count medians. Cohortias’ $2M–$4M / 1-year U.S. skip figures are their claims.