Category: Navigating Regulatory Landscapes in Latin America

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.

More on Colombia

• INVIMA device clinical trial approvals 2021–2025
• Top CROs in Colombia for biopharma trials (INVIMA register)
• Biotech and phase 1 trials in Colombia
• COSMOS Scientific vs bioaccess®
• CogenTech and LA Research SAS in Colombia
• Clinlogix in Colombia, now part of NAMSA
• Coltrials vs bioaccess®

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.

Más sobre Colombia

• Ensayos clínicos con dispositivos médicos en Colombia
• Ensayos clínicos con medicamentos y biotecnología en Colombia
• INVIMA device approvals 2021–2025 (EN)