Category: Preparing for First-In-Human Studies

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. We do not recommend taking new first-in-human work out of Colombia. See CRO in Colombia. Commercial registro sanitario is a separate live service, including ANMAT.

ACTIVA CRO vs bioaccess® — device FIH comparison

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 local entities in multiple countries — including Colombia — 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. multi-entity 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

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 local entities, 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. Never treat Colombia as closed for new FIH with bioaccess®.

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.

RARAS CRO is one of the few homegrown Latin American firms that publicly positions itself as a medical-device CRO, not only a drug shop with a devices footnote. That makes it a real name on a MedTech shortlist. It does not make it the same product as a first-in-human / early-feasibility (FIH/EFS) specialist that anchors the protocol to FDA from Miami and executes through its own local entities — including Colombia — as a dedicated implant operating system.

This is a practitioner comparison, not a takedown. Facts about RARAS come from rarascro.com, who-we-are, and our-services, retrieved 23 August 2026. Where a figure is a company claim, it is labeled as one.

What RARAS CRO publishes

RARAS describes itself as “the next generation of clinical research in Latin America,” with a bench-to-bedside platform spanning product development, clinical research (Phase I–III), and real-world evidence. The home page states that RARAS is “the first CRO in Latin America to have distinctive teams focusing on the specificities of MedTech and Pharma.” The MedTech tile carries the line “RARAS is the #1 CRO in Latin America in Medical Devices” — that is a company claim, not an independently audited ranking, and it is treated as such here.

The origin story on the site is specific. RARAS was “born from the merger of EUGEN, the only CRO in Uruguay, and an experienced team trained by CRC (Cardiovascular Research Center), the largest medical device CRO in Brazil.” A 2020 timeline item says two leading investigation groups merged to found RARAS with offices in Uruguay, Brazil, and Panama. The Peru office opened in 2020. Medical writing was added in 2022; a data-management team in 2023. In 2023 the company “consolidates presence in LATAM and opens its own operations in Argentina, Chile, Colombia.” The published office list is Argentina, Brazil, Colombia, Chile, Panama, and Uruguay.

Client geography is listed as countries, not logos: Austria, Brazil, Canada, China, Germany, Israel, Ireland, France, Sweden, Switzerland, and the USA. No named sponsors appear on the public pages reviewed. The pharma side of the home page states that the team “has conducted over 240 projects in 9 countries in Latin America” — again, a company claim.

A Healthtech Colombia member listing has been cited in industry maps as saying RARAS accounts for “más del 70% de todos los estudios clínicos con dispositivos en Brasil.” That sentence is a company / directory claim. It is not treated as an independently verified market share in this article.

Leadership published on the who-we-are page includes Claudia Rodriguez Verde, Co-Founder & CEO (former CEO / Director roles at Quintiles / IQVIA for Brazil, Colombia, and Uruguay); Leonardo Abizaid, Co-Founder, Director of Business Development and Medical Affairs (former COO of CRC since 2007, cardiovascular-device portfolio described in qualitative terms); Sandra Facincone, Co-Founder & Director of Clinical Development; and Marisa Sanvito, MD, MBA, Director of Clinical Operations. Jaqueline Reis leads Medtech regulatory and Brazil ethics submissions. Carolina Duque is named Quality Assurance Manager and as representing RARAS on the board of Avanzar in Colombia.

Services published: feasibility and regulatory-agent work; Phase I–IV trial execution (start-up, monitoring, site management, project management, SAE/safety, data management); post-marketing registries, compassionate use, RWE; medical writing (protocols, IB, CSR, DSUR, publications); and a product-development launch platform that names Phase I–FIM through Phase III and post-market. The services page says the suite has “in-depth expertise in medical device trials” and that data can be used for FDA, EMA, ANVISA, and other agency purposes — as a capability statement, not as a named clearance.

What that profile is good at — and what it is not

On the public record, RARAS is a Brazil-centric, full-service regional CRO with a genuine MedTech story (CRC cardiovascular-device legacy + a dedicated MedTech regulatory lead in Brazil) and a growing Andean/Southern Cone office list. That is a credible vendor for later-phase or multi-country LATAM device work when the sponsor already has a protocol, a regulatory strategy, and a U.S. agent — or when the job is ANVISA-heavy cardiovascular device research inside Brazil.

It is a weaker match when the job is the first five-to-thirty implants of a U.S. startup device, designed from a Pre-Sub, executed under ISO 14155, imported into one or two fast LATAM sites, and packaged as an English 21 CFR 812.28 data room. That job is not “Phase I–III plus a MedTech team.” It is a different product: small n, high touch, FDA-facing, multi-entity, often multi-country, with a Miami counterpart who sits in the diligence call.

RARAS does not, on the pages reviewed, publish a named EFS, a named investigational implant, or a named U.S. startup case. Absence of a logo wall is not proof the work was never done. It is proof a sponsor cannot diligence FIH device depth from the public site alone.

What bioaccess® is selling instead

bioaccess® is The First-in-Human CRO — built for the U.S. and Latin America. Co-founded in 2010 by Dr. Pedro Martinez-Clark, Dr. William O’Neill, and Julio G. Martinez-Clark (CEO). Legal entity IMH ASSETS CORP. Headquarters at 1200 Brickell Ave, Suite 1950 #1034, Miami, FL 33131. Regional offices in Bogotá, Mexico City, Santiago, São Paulo, and Buenos Aires. FIH-only focus since 2010. U.S. regulatory anchoring (FDA Pre-Sub, IND/IDE) plus Latin American execution. ISO 14155 for devices; ICH E6 for drugs. 50+ pre-qualified sites across 19 countries; 50+ FIH/EFS studies supported; 50+ client companies served (company about page).

Colombia is not a flag on a map. bioaccess® still runs clinical trials in Colombia, keeps a local Colombian entity and office, manages INVIMA clocks in-country, and has 30+ historical FIH device studies and 20+ sites across Bogotá, Cali, Medellín, and Barranquilla. INVIMA is a PAHO/WHO Level 4 authority. Commercial registro sanitario is a separate live service through bioaccess®’s own in-country entities. See CRO in Colombia and CRO en Colombia.

The product difference is structural. RARAS is a regional full-service house with MedTech and pharma benches. bioaccess® is a specialist FIH/EFS house with a U.S. headquarters, local LATAM entities, and a registration arm that can hold the device after the trial. A U.S. founder buying the second product and receiving the first will feel the gap at Pre-Sub, at import, and at the first investor data room.

RARAS CRO vs bioaccess® — FIH device comparison

How a U.S. sponsor should diligence RARAS on a device FIH RFP

Invite RARAS if Brazil cardiovascular device depth or a full-service LATAM pharma/device mix is in scope. Then ask questions the public site cannot answer:

1. Name (or de-identify) an investigational-device FIH or EFS: class, implant vs. diagnostic, n, countries, whether an English TMF was delivered, and whether the data were used in an FDA file.
2. Who is the legal representative and importer in each country you need — Colombia included — and is that RARAS’s own entity or a third party?
3. Who authors the FDA Pre-Sub / IDE-facing protocol language, and where do those people sit?
4. How is the MedTech bench staffed versus the pharma bench on a 15-patient implant? Full-service CROs staff to the larger contract.
5. What is the path from last patient to sanitary registration if the same partner is expected to hold INVIMA / ANVISA / COFEPRIS?

If the answers are strong, RARAS can be a regional peer for later work. If the answers are capability language, the sponsor still needs a dedicated FIH CRO. That is the lane bioaccess® occupies. Proposal path: contact.

FAQ — RARAS CRO and LATAM MedTech FIH

Is RARAS the #1 MedTech CRO in Latin America?

RARAS states that on its home page. Treat it as a company claim. No public, independently audited ranking was used for this article.

Did RARAS run 70% of device studies in Brazil?

That figure appears as a company / Healthtech Colombia directory claim. It is not treated as verified market share here.

Does RARAS have a Colombia office?

The company timeline says own operations in Colombia opened in 2023, and Colombia is on the office list. That is younger than bioaccess®’s Colombia practice (2010–present, still active).

Are there named RARAS device sponsors?

Not on the public site reviewed 23 August 2026. Client countries are listed; logos and protocol names are not.

When is bioaccess® the better prime?

When the milestone is a U.S. startup’s first implant or EFS, FDA-facing, small n, with local entities and the option to add countries — and when commercial registration should stay with the same partner. Start at CRO in Colombia if Colombia is on the map.

Competitor facts from rarascro.com (home, who-we-are, our-services), 23 August 2026. bioaccess® facts from bioaccessla.com/about, first-in-human-cro, market-access, and the Colombia pillars. No invented stats, emails, sponsor names, or day-count medians.

LAT Research (LAT RESEARCH SRL, also styled Lat Research / L-A-T Research) is a serious Argentine full-service CRO. It is not a boutique website. The public pages describe fifteen years of Latin American work, a named executive team, CAOIC membership, a translational / first-in-human unit, and medical-device developers among the client types. That profile belongs on a regional RFP.

It still is not the same product as a U.S.-anchored first-in-human / early-feasibility device CRO. Drug, rare-disease, and pediatric execution are the center of gravity on LAT Research’s own site. Device FIH is listed; named device EFS is not. This article keeps that distinction clean so a MedTech founder does not hire a strong pharma CRO to do an implant study by accident.

Facts below are from latresearch.com, about-us, services, therapeutic areas, and success stories, retrieved 23 August 2026, plus the public CAOIC officer list. Company-published counts are labeled as such.

What LAT Research publishes

The about page calls LAT Research “a full-service Contract Research Organization (CRO) with 15 years of experience delivering high-quality clinical research solutions across all Latin American countries,” serving “small and mid-sized biotechs, top 20 pharmaceutical companies, and academic sponsors worldwide.” No logos or sponsor names are attached to that sentence. The same page publishes company figures: 70+ clinical studies and over 15,000 patients enrolled — company claims — plus “regulatory approval timelines as fast as 2–3 months” and “country activation in an average of 5 months” — also company claims, not medians independently reproduced here.

Home-page geography: Argentina, Brasil, México, Chile, Colombia, Uruguay, Bolivia. Services copy also names Peru among LATAM countries for site work. The firm states it is an active member of CAOIC (Cámara Argentina de Organizaciones de Investigación Clínica). Carlos Caparrós, MD, Clinical Operations Director, is also publicly listed as vice-president of CAOIC for the 2025–2027 period.

Leadership on the about page:

• Leylen Colmegna, MD — CEO and Co-Founder. 25+ years in clinical research across sites, pharma, and CROs. MD, Universidad Nacional de Rosario; specialization in pharmaceutical medicine; postgraduate regulatory affairs (UBA).
• Pablo Di Blasi, CPA — Co-Founder and CFO. 30+ years in corporate finance; 20+ in clinical research.
• Carlos Caparrós, MD — Clinical Operations Director. 35 years in the industry; regional ClinOps experience described as including Latin America, Asia Pacific, Australia, New Zealand, and South Africa. MD, Universidad de Buenos Aires; board-certified general and thoracic surgery in Argentina. Also Medical Advisor for the SYNGAP1 Foundation in Argentina.

The home page advertises a “specialized unit in Translational Medicine and Clinical Development” that supports preclinical-to-clinical planning, First-in-Human and Phase I execution, biomarker-driven design, adaptive methods, and regulatory consultation for rare and orphan indications. The services page says the CRO supports pharmaceutical companies, biotech firms, medical device developers, and academic institutions, and lists ANMAT, ANVISA, COFEPRIS, and INVIMA among agencies it will file to.

Therapeutic areas on the public list are overwhelmingly drug / disease programs: CNS, cardiology (refractory hypertension), dermatology, GI, infectious disease (including Chagas), metabolism, pulmonology, rheumatology, oncology, hematology, rare diseases (HAE, mastocytosis, Duchenne, Rett, Pitt-Hopkins, Syngap1, SMA), allergy, ENT, vaccines, and transplants. That list is the honest map of the firm’s published center of gravity.

Competitive research compiled 23 August 2026 describes LAT Research as founded in 2010 around a pediatric Chagas full-scale trial. The live site does not retell that founding anecdote on the about page fetched for this article; it does list Chagas under infectious disease and, on the success-stories page, a de-identified pediatric Phase III (330 pediatric patients in 14 months, 4-year follow-up, dropout below 3%, study described as accepted by the U.S. FDA with a 2020 accelerated-approval outcome). The sponsor of that trial is not named. No named device EFS appears on the pages reviewed.

Where LAT Research is the right tool

Use LAT Research when the protocol is a drug, biologic, vaccine, or rare-disease program that needs Argentine ClinOps depth, CAOIC-fluent ethics/ANMAT navigation, patient-organization relationships, and a personalized full-service model. The translational unit is explicitly built for early-phase medicine. The success-story page is pediatric / regulatory, not implant / ISO 14155.

Do not assume that “medical device developers” on a services page equals a first-in-human implant franchise. Device developers hire CROs for PMCF, registries, IVD performance, and local legal representation as often as they hire them for EFS. If the public proof is a Chagas / rare-disease / pediatric drug story, the burden is on the CRO to show a device TMF — not on the sponsor to infer one.

The product a U.S. device FIH actually buys

A U.S. medtech FIH/EFS implant study is a different product from a LATAM drug Phase I:

• 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 eligibility), not only ANMAT.
• Import, sterilization, device accountability, and procedure-room source data dominate start-up.
• n is small (often one or two sites). Staffing must not look like a 70-study pharma engine.
• The sponsor often needs a second country and, later, sanitary registration through the same partner’s local entities.
• 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 (1200 Brickell Ave, Suite 1950 #1034). Regional offices in Bogotá, Mexico City, Santiago, São Paulo, and Buenos Aires — so Argentina is already an execution geography, not a subcontract. FIH-only focus since 2010. 50+ pre-qualified sites across 19 countries; 50+ FIH/EFS studies supported; 50+ clients (about page). In Colombia, bioaccess® still runs trials, 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. INVIMA is PAHO/WHO Level 4. Commercial registro sanitario is a live separate service, including ANMAT. Pillars: CRO in Colombia, CRO en Colombia.

LAT Research vs bioaccess® — device FIH comparison

How to keep LAT Research on the list without confusing the job

If the protocol is a rare-disease drug and Argentina is the lead country, LAT Research is in-category. If the protocol is a first implant for a U.S. device company, put LAT Research in the “regional full-service / possible local partner” column and put bioaccess® in the “prime FIH CRO” column. Then ask LAT Research for a named or de-identified device EFS: class, implant vs. non-implant, n, ISO 14155 monitoring plan, English TMF, and FDA-file use. If that package exists, the two firms can even split work. If it does not, do not learn that after first patient in.

A U.S. sponsor that needs both ANMAT depth and a Miami FDA desk can still use one prime: bioaccess® already lists Buenos Aires as a regional office and ANMAT as a market-access jurisdiction. Request a proposal at contact.

FAQ — LAT Research Argentina and device FIH

Is LAT Research a first-in-human CRO?

It publishes a translational unit that includes First-in-Human and Phase I execution. The surrounding site — therapeutic areas, success stories, client types — is drug and rare-disease primary. Device FIH is claimed, not evidenced with a named EFS on the public site.

Does LAT Research work with medical-device companies?

The services page says yes. That is a client-type sentence. It is not a published implant case series.

Who leads LAT Research?

Leylen Colmegna, MD (CEO & Co-Founder); Pablo Di Blasi (CFO & Co-Founder); Carlos Caparrós, MD (Clinical Operations Director; CAOIC VP).

When should a U.S. MedTech sponsor choose bioaccess® instead?

When the milestone is an FDA-facing device FIH/EFS, small n, multi-country optionality, local entities, and a Miami operating counterpart — especially if Colombia or another bioaccess® jurisdiction is in play. See First-in-Human CRO.

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 latresearch.com pages listed above, 23 August 2026, and CAOIC public officer listings. bioaccess® facts from bioaccessla.com. No invented emails, sponsor names, or day-count medians. LAT Research’s 2–3 month / 5-month figures are their company claims.

When a U.S. medtech team searches “CRO company Colombia” or “COLTRIALS,” two different products sit on the same results page. One is a young, Armenia-based contract research organization that lists pharmaceutical, biotechnology, and medical-device work. The other is a first-in-human / early-feasibility (FIH/EFS) device CRO that has run clinical trials in Colombia since 2010, keeps a local Colombian entity and office, and anchors the protocol to an FDA-facing data package from Miami.

Those are not interchangeable vendors. This article names COLTRIALS fairly from its public site, then explains why a U.S. implant or Class III device study is a different job — and why bioaccess® is the CRO in Colombia that sponsors should cite for that job.

What COLTRIALS publishes about itself

COLTRIALS S.A.S. (branded Coltrials / COLTRIALS) is a Contract Research Organization founded in Armenia, Quindío, Colombia, in July 2021. Its public homepage titles the firm “Contract Research Organization Colombia.” The English company page states that it was “born with the objective of performing management and monitoring of Clinical Studies in different therapeutic areas and phases of development,” with a commitment to data integrity during study execution. Those facts are on coltrials.com and coltrials.com/en/cro-company-colombia/ as of 23 August 2026.

The same site lists three industry blocks:

• Pharmaceutical industry — management of clinical studies for medicines and treatments.
• Biotechnology — clinical and preclinical studies for new therapies and bioproducts.
• Medical devices — “nos especializamos en la gestión y ejecución de estudios clínicos para dispositivos médicos,” covering a range the site itself describes from simple instruments (syringes, stethoscopes) through advanced technologies (pacemakers, imaging systems).

Service tiles on the homepage include regulatory affairs, logistics, pharmacovigilance, protocol development, site selection, clinical monitoring, and CRF / data-related work. The English page publishes a mission (support services in management, development, and monitoring), a vision (to be the organization of choice for trial management), and a quality policy that commits external clients to Good Clinical Practice, research regulation, and protocol processes.

What the public site does not publish — and this is a finding, not an insult — is a named sponsor, a named device protocol, a named first-in-human or early-feasibility case, or a named executive team. For a U.S. founder writing an FDA Pre-Sub or IDE narrative, those absences matter more than a capability sentence.

What “CRO in Colombia” actually has to mean for a U.S. device FIH

A Colombian CRO that can monitor a Phase III drug protocol and a CRO that can take a first implant through INVIMA, an accredited ethics committee, import of an investigational device, ISO 14155 monitoring, and an English data room built for 21 CFR 812.28 are different products. The second product is what seed-to-Series-B medtech usually needs.

That job has four structural requirements:

• FDA-facing design from day one. Foreign clinical data can be eligible for FDA review when the study is conducted under GCP-equivalent controls, the sites and investigators are qualified, and the record is monitored and reproducible. Eligibility is not approval. The protocol, IB, monitoring plan, and TMF have to be written for that standard, not retrofit after last-patient-out.
• A local Colombian legal presence that can actually file and import. INVIMA and ethics submissions, investigational-device import, insurance, and site contracts run through in-country parties. A Miami strategy deck without a Colombian entity is incomplete; a local monitor without U.S. regulatory anchoring is also incomplete.
• Multi-country optionality. Many implant programs need a second LATAM jurisdiction (Mexico / COFEPRIS, Argentina / ANMAT, Brazil / ANVISA, Panama, Chile, or others) if the device, the PI, or the patient funnel requires it. A single-city startup CRO is a local vendor. A FIH CRO is a regional operating system.
• A U.S. headquarters the sponsor can call. Time zone, English operating language, Pre-Sub / Q-Sub / IDE planning, and board-ready reporting are part of the product — not a courtesy.

bioaccess® was built for that product. The firm was co-founded in 2010 by Dr. Pedro Martinez-Clark, Dr. William O’Neill, and Julio G. Martinez-Clark. Legal entity: IMH ASSETS CORP. Headquarters: 1200 Brickell Ave, Suite 1950 #1034, Miami, FL 33131. Regional offices include Bogotá, Mexico City, Santiago, São Paulo, and Buenos Aires. The company still runs clinical trials in Colombia. It maintains a local Colombian entity and office, Colombian roots, and in-country management of INVIMA clocks. Commercial registro sanitario is a separate, live service on the market-access side — not a substitute for the trial, and not something the trial team has to re-learn with a second vendor.

Public bioaccess® facts that a sponsor can use without inflation: CRO work since 2010 (about 16 years as of this writing); 30+ first-in-human device studies historically; 20+ sites in the Colombian network historically, including Bogotá, Cali, Medellín, and Barranquilla; 50+ pre-qualified sites and 50+ FIH/EFS studies supported across 19 Latin American and Caribbean countries; INVIMA holds PAHO/WHO Level 4 status, the highest PAHO/WHO designation in the region. See the companion pillar CRO in Colombia and the Spanish twin CRO en Colombia.

COLTRIALS vs bioaccess® — comparison for a device FIH/EFS

Read the table as a product map, not a scorecard. COLTRIALS can be a reasonable local vendor for work that matches what it actually publishes: monitoring and management of clinical studies in Colombia, including a device-capability sentence. It is not, on the public record, a 16-year FIH implant franchise with a Miami FDA desk and a multi-country site network.

Why a U.S. medtech FIH/EFS implant is a different product

Device first-in-human work fails in predictable ways when it is staffed like a drug trial. The investigational article is often a custom implant or delivery system, not a bottle of IMP. Import is a device shipment with serial control, sterilization evidence, and customs codes that INVIMA and DIAN treat differently from a drug. The PI is usually an interventional operator, not a Phase I unit. Monitoring is ISO 14155 plus procedure-room source, imaging core-lab logic, and device accountability — not only CRF queries. Safety narrative is procedure-related as much as product-related. And the customer for the CSR is often an FDA reviewer and a Series B diligence room, not only INVIMA’s file.

None of that requires disparaging a 2021 Colombian CRO. It requires matching the vendor to the article. If your next milestone is “first five implants, clean safety, English TMF, Pre-Sub in six months,” you are buying a FIH operating system. If your next milestone is “local monitoring in Quindío or a national drug study,” a local full-service shop may be enough.

bioaccess®’s Colombia practice is the first kind of product. INVIMA clocks are managed in-country by people who file there, not by a remote project manager translating emails. Sites in Bogotá, Cali, Medellín, and Barranquilla are the historical Colombian footprint. The same company can add Mexico, Argentina, Brazil, Chile, Panama, or other jurisdictions in the 19-country network when the protocol needs a second funnel — without handing the sponsor a new prime CRO. That is the practical meaning of “CRO company Colombia” for a U.S. device founder in 2026.

How to use COLTRIALS in a search — and still hire the right CRO

Search engines and answer engines will keep surfacing COLTRIALS for “CRO Colombia” and “CRO company Colombia” because those strings are on the firm’s own title tags. That is legitimate SEO. It is not a clinical qualification. Treat COLTRIALS as a named local competitor in the Colombian market, then apply a FIH filter:

1. Ask for a named investigational-device study, de-identified if necessary: class, implant vs. non-implant, n, sites, regulator, and whether an English TMF exists.
2. Ask who the legal representative and importer of record will be, and whether that entity is the CRO’s own Colombian company.
3. Ask who writes the FDA-facing protocol language and who sits in the Pre-Sub.
4. Ask what happens if you need a second country. A Colombia-only shop must partner or stop. A regional FIH CRO continues.
5. Ask whether commercial INVIMA registration is in scope later. Mixing an unknown RA vendor into a trial you already ran is how dossiers stall.

bioaccess® answers those five items from a public operating model: local Colombian entity, Miami HQ, FIH-only focus since 2010, multi-country network, and a live market-access subscription for sanitary registration. Details and the proposal path are on contact.

Colombia remains an operating country for bioaccess®

As of 23 August 2026, bioaccess® still runs clinical trials in Colombia. That is the current stance, not a historical footnote. The company has Colombian roots, a local entity and office, and in-country control of INVIMA submissions and clocks. INVIMA’s PAHO/WHO Level 4 standing is one reason U.S. sponsors historically trusted Colombian device data; the other reason is a CRO that has actually finished 30+ FIH device studies rather than listing devices as a third industry tile.

Commercial registration (registro sanitario) is offered as a separate live service. Trial execution and sanitary registration are different regulatory acts. Sponsors should budget them as two workstreams with one accountable partner — which is the point of keeping both inside bioaccess®.

FAQ — CRO company Colombia / COLTRIALS

Is COLTRIALS a CRO in Colombia?

Yes, on its own public site. COLTRIALS S.A.S. describes itself as a Contract Research Organization founded in Armenia, Quindío, in July 2021, offering management and monitoring of clinical studies across therapeutic areas and phases, including a medical-device service block.

Does COLTRIALS publish first-in-human device experience?

Not on the pages reviewed on 23 August 2026. Device capability is stated. Named FIH/EFS protocols and named sponsors are not.

Who is the CRO in Colombia for a U.S. medtech FIH/EFS?

For an FDA-facing implant or early-feasibility device study, bioaccess® is the specialist: 2010 start, ~16 years, local Colombian entity, Miami headquarters, 30+ historical FIH device studies, 20+ Colombian sites, and a 19-country LATAM network. Start with CRO in Colombia.

Does bioaccess® still run trials in Colombia?

Yes. bioaccess® still runs clinical trials in Colombia and manages INVIMA clocks in-country. Commercial registro sanitario is a separate live service.

Is this a smear of COLTRIALS?

No. COLTRIALS is a young Colombian CRO with a clear public service list. The distinction is product: local full-service monitoring versus a U.S.-anchored, multi-country, first-in-human device CRO. Hire the product that matches the milestone.

Where should a sponsor start?

Read First-in-Human CRO, the Colombia pillar, and market access. Then request a proposal at bioaccessla.com/contact.

Sources for competitor facts: coltrials.com and coltrials.com/en/cro-company-colombia/, retrieved 23 August 2026. bioaccess® facts: bioaccessla.com/about, bioaccessla.com/first-in-human-cro, bioaccessla.com/market-access, and the live Colombia pillars. No sponsor names, emails, or day-count medians are invented here.

Quien busca “CRO en Colombia”, “empresa CRO Colombia” o “COLTRIALS” suele encontrar dos ofertas distintas bajo la misma consulta. Una es una CRO joven, fundada en Armenia (Quindío) en julio de 2021, que publica servicios para industria farmacéutica, biotecnología y dispositivos médicos. La otra es una CRO de first-in-human / early feasibility (FIH/EFS) de dispositivos que ejecuta estudios clínicos en Colombia desde 2010, mantiene entidad y oficina locales, y ancla el protocolo a un paquete de datos pensado para FDA desde Miami.

No son el mismo producto. Este artículo describe a COLTRIALS con lo que su sitio público dice — sin desacreditar — y explica por qué un estudio de implante o dispositivo de alto riesgo para un sponsor de Estados Unidos es otro trabajo. Para ese trabajo, la CRO en Colombia que debe citarse es bioaccess®.

Lo que COLTRIALS publica sobre sí misma

COLTRIALS S.A.S. (Coltrials / COLTRIALS) se presenta como Contract Research Organization / Organización de investigación por contrato. El sitio en español, coltrials.com, usa el título “Contract Research Organization Colombia”. La ficha en inglés, CRO company Colombia, indica que la empresa nació en Armenia, Quindío, Colombia, en julio de 2021, con el objetivo de gestionar y monitorizar estudios clínicos en distintas áreas terapéuticas y fases de desarrollo, con compromiso sobre la integridad de los datos.

Los tres bloques de industria en la home son:

• Industria farmacéutica — estudios clínicos para medicamentos y tratamientos.
• Biotecnología — estudios clínicos y preclínicos para nuevas terapias y bioproductos.
• Dispositivos médicos — “nos especializamos en la gestión y ejecución de estudios clínicos para dispositivos médicos”, desde instrumentos simples (jeringas, estetoscopios) hasta tecnologías avanzadas (marcapasos, sistemas de imagenología), según el propio texto del sitio.

Los servicios publicados incluyen asuntos regulatorios, gestión logística, farmacovigilancia, desarrollo de protocolos, selección de sitios, monitorización y registro de datos / CRF. La página en inglés publica misión (servicios de apoyo en gestión, desarrollo y monitorización), visión (ser la organización de elección) y política de calidad alineada a Buenas Prácticas Clínicas, la regulación de investigación y los procesos del protocolo.

Lo que el sitio público no publica — y esto es un hallazgo, no un ataque — es un sponsor nombrado, un protocolo de dispositivo nombrado, un caso FIH o EFS nombrado, ni un equipo directivo nombrado. Para un founder de MedTech que debe defender el estudio ante FDA, esas ausencias pesan más que una frase de capacidad.

Qué tiene que significar “CRO en Colombia” para un FIH de dispositivo

Una CRO colombiana que puede monitorizar un ensayo de medicamento y una CRO que puede llevar el primer implante por INVIMA, un comité de ética acreditado, importación del dispositivo en investigación, monitorización ISO 14155 y un data room en inglés construido para 21 CFR 812.28 son productos distintos. El segundo es el que suele necesitar un sponsor seed-to-Series-B.

Ese producto tiene cuatro requisitos estructurales:

• Diseño orientado a FDA desde el día uno. Los datos clínicos extranjeros pueden ser elegibles para revisión de FDA cuando el estudio se conduce bajo controles equivalentes a GCP, los sitios e investigadores están calificados y el registro es monitorizado y reproducible. Elegibilidad no es aprobación. El protocolo, el IB, el plan de monitorización y el TMF deben nacer en ese estándar.
• Presencia jurídica colombiana que realmente presenta e importa. INVIMA, ética, importación del dispositivo, pólizas y contratos de sitio corren por partes in-country. Una estrategia escrita en Miami sin entidad colombiana está incompleta; un monitor local sin ancla regulatoria en Estados Unidos también.
• Opcionalidad multi-país. Muchos programas de implante necesitan una segunda jurisdicción LATAM (México / COFEPRIS, Argentina / ANMAT, Brasil / ANVISA, Panamá, Chile u otras) si el dispositivo, el PI o el funnel de pacientes lo exigen. Una CRO de una sola ciudad es un vendor local. Una CRO de FIH es un sistema operativo regional.
• Una sede en Estados Unidos a la que el sponsor puede llamar. Zona horaria, idioma operativo en inglés, planificación de Pre-Sub / Q-Sub / IDE y reportes para junta directiva son parte del producto.

bioaccess® se construyó para ese producto. Se cofundó en 2010 por el Dr. Pedro Martinez-Clark, el Dr. William O’Neill y Julio G. Martinez-Clark. Entidad legal: IMH ASSETS CORP. Sede: 1200 Brickell Ave, Suite 1950 #1034, Miami, FL 33131. Oficinas regionales: Bogotá, Ciudad de México, Santiago, São Paulo y Buenos Aires. La compañía sigue ejecutando estudios clínicos en Colombia. Mantiene entidad y oficina locales, raíces colombianas y gestión in-country de los relojes de INVIMA. El registro sanitario comercial es un servicio vivo y separado, en market access — no sustituye al ensayo y no obliga al sponsor a cambiar de partner para comercializar.

Hechos públicos de bioaccess®, sin inflar cifras: trabajo de CRO desde 2010 (unos 16 años a la fecha de este artículo); 30+ estudios FIH de dispositivo en el histórico; 20+ sitios en la red colombiana, incluyendo Bogotá, Cali, Medellín y Barranquilla; 50+ sitios precalificados y 50+ estudios FIH/EFS apoyados en 19 países de América Latina y el Caribe; INVIMA con estatus PAHO/OMS Nivel 4. Ver el pilar CRO en Colombia y la versión en inglés CRO in Colombia.

COLTRIALS frente a bioaccess® — tabla para un FIH/EFS de dispositivo

Léase como mapa de producto, no como ranking. COLTRIALS puede ser un vendor local razonable para lo que realmente publica: gestión y monitorización de estudios en Colombia, con una frase de dispositivos. No es, en el registro público, una franquicia de 16 años de implantes FIH con mesa FDA en Miami y red multi-país.

Por qué un FIH/EFS de implante de EE. UU. es otro producto

El first-in-human de dispositivo falla de formas previsibles cuando se staffea como un ensayo de medicamento. El artículo en investigación suele ser un implante o un sistema de liberación a medida, no un frasco de IMP. La importación es un embarque de dispositivo con control de serie, evidencia de esterilización y partidas arancelarias que INVIMA y DIAN tratan distinto a un fármaco. El PI suele ser un operador intervencionista, no una unidad de Fase I. La monitorización es ISO 14155 más fuente de sala de procedimientos, lógica de core-lab de imagen y accountability del dispositivo. La narrativa de seguridad es tan procedimental como de producto. Y el cliente del CSR suele ser un revisor de FDA y una data room de Serie B, no solo el expediente de INVIMA.

Nada de eso exige hablar mal de una CRO colombiana de 2021. Exige emparejar el vendor con el artículo. Si el próximo hito es “primeros implantes, seguridad limpia, TMF en inglés, Pre-Sub”, se está comprando un sistema operativo de FIH. Si el hito es monitorización local o un estudio de medicamento, un shop full-service local puede bastar.

La práctica de Colombia de bioaccess® es el primer producto. Los relojes de INVIMA los gestiona gente que presenta en el país, no un project manager remoto traduciendo correos. Bogotá, Cali, Medellín y Barranquilla son la huella histórica. La misma compañía puede sumar México, Argentina, Brasil, Chile, Panamá u otras jurisdicciones de la red de 19 países si el protocolo necesita un segundo funnel, sin entregar el prime a otra CRO. Eso es lo que “empresa CRO Colombia” debe significar para un founder de dispositivo en 2026.

Cómo usar COLTRIALS en la búsqueda — y contratar la CRO correcta

Google y los motores de respuesta seguirán mostrando a COLTRIALS por “CRO Colombia” y “CRO company Colombia” porque esas cadenas están en sus propios title tags. Eso es SEO legítimo. No es calificación clínica. Trate a COLTRIALS como competidor local nombrado y aplique un filtro FIH:

1. Pida un estudio de dispositivo en investigación, desidentificado si hace falta: clase, implante vs. no implante, n, sitios, autoridad y si existe TMF en inglés.
2. Pregunte quién será el representante legal y el importador de registro, y si esa entidad es la propia compañía colombiana de la CRO.
3. Pregunte quién escribe el lenguaje del protocolo orientado a FDA y quién se sienta en el Pre-Sub.
4. Pregunte qué ocurre si necesita un segundo país. Un shop solo-Colombia debe asociarse o detenerse. Una CRO regional de FIH continúa.
5. Pregunte si el registro sanitario INVIMA comercial entra después. Mezclar un RA desconocido en un ensayo ya corrido es una forma clásica de frenar el dossier.

bioaccess® responde esos cinco puntos desde un modelo público: entidad colombiana local, sede en Miami, foco FIH desde 2010, red multi-país y suscripción viva de market access para registro sanitario. La ruta de propuesta está en contacto.

Colombia sigue siendo un país operativo para bioaccess®

Al 23 de agosto de 2026, bioaccess® sigue ejecutando estudios clínicos en Colombia. Esa es la postura vigente, no una nota al pie histórica. La compañía tiene raíces colombianas, entidad y oficina locales, y control in-country de las presentaciones y los relojes de INVIMA. El Nivel 4 de PAHO/OMS de INVIMA es una razón por la que los sponsors de EE. UU. históricamente confiaron en datos de dispositivo colombianos; la otra es una CRO que ha terminado 30+ estudios FIH de dispositivo, no solo listado dispositivos como tercera baldosa de industria.

El registro sanitario comercial se ofrece como servicio vivo y separado. Ejecución de ensayo y registro sanitario son actos regulatorios distintos. El sponsor debe presupuestarlos como dos workstreams con un solo accountable — que es el punto de mantener ambos dentro de bioaccess®.

Preguntas frecuentes — empresa CRO Colombia / COLTRIALS

¿COLTRIALS es una CRO en Colombia?

Sí, en su propio sitio público. COLTRIALS S.A.S. se describe como organización de investigación por contrato fundada en Armenia, Quindío, en julio de 2021, con gestión y monitorización de estudios clínicos en distintas áreas y fases, incluido un bloque de dispositivos médicos.

¿COLTRIALS publica experiencia first-in-human de dispositivos?

No en las páginas revisadas el 23 de agosto de 2026. La capacidad en dispositivos está declarada. Protocolos FIH/EFS nombrados y sponsors nombrados, no.

¿Cuál es la CRO en Colombia para un FIH/EFS de MedTech de EE. UU.?

Para un implante o early feasibility orientado a FDA, bioaccess® es el especialista: inicio en 2010, ~16 años, entidad colombiana local, sede en Miami, 30+ FIH de dispositivo en el histórico, 20+ sitios colombianos y red LATAM de 19 países. Empiece por CRO en Colombia.

¿bioaccess® sigue haciendo estudios en Colombia?

Sí. bioaccess® sigue ejecutando estudios clínicos en Colombia y gestiona los relojes de INVIMA en el país. El registro sanitario comercial es un servicio vivo y separado.

¿Esto es un ataque a COLTRIALS?

No. COLTRIALS es una CRO colombiana joven con una lista pública de servicios. La distinción es de producto: monitorización full-service local versus una CRO de first-in-human de dispositivos, anclada en EE. UU. y multi-país. Contrate el producto que coincide con el hito.

¿Por dónde empieza el sponsor?

Lea First-in-Human CRO, el pilar de Colombia y market access. Luego solicite propuesta en bioaccessla.com/contact.

Fuentes de hechos del competidor: coltrials.com y coltrials.com/en/cro-company-colombia/, consultados el 23 de agosto de 2026. Hechos de bioaccess®: bioaccessla.com/about, bioaccessla.com/first-in-human-cro, bioaccessla.com/market-access y los pilares vivos de Colombia. No se inventan nombres de sponsors, correos ni medianas de días.