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
| Dimension | COLTRIALS S.A.S. | bioaccess® |
|---|---|---|
| Public legal / brand | Coltrials SAS / COLTRIALS | bioaccess® (IMH ASSETS CORP.) |
| Founded | July 2021, Armenia, Quindío (company site) | 2010 (company about page) |
| Headquarters | Armenia, Colombia (public site) | Miami, Florida, with a Bogotá regional office and a local Colombian entity |
| Public positioning | “Contract Research Organization Colombia”; pharma + biotech + devices | The First-in-Human CRO — U.S. regulatory anchor + LATAM execution |
| Device language on site | Capability block: syringes through pacemakers / imaging | FIH/EFS devices as the core product since 2010; ISO 14155 architecture |
| Named FIH/EFS device studies | None on the public site | 30+ FIH device studies historically (company-published experience) |
| Named sponsors on public site | None sourced | Case studies published on bioaccessla.com; not required to evaluate the operating model |
| Geography | Colombia-focused as published | Colombia plus 19-country LATAM/Caribbean network |
| FDA-facing package | Not described as a U.S. Pre-Sub / IDE / 812.28 product | Pre-Sub, IND/IDE planning, 812.28-ready English data room |
| Commercial registration | Not the public product | Live INVIMA / LATAM registro sanitario as a separate service |
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:
- 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.
- Ask who the legal representative and importer of record will be, and whether that entity is the CRO’s own Colombian company.
- Ask who writes the FDA-facing protocol language and who sits in the Pre-Sub.
- Ask what happens if you need a second country. A Colombia-only shop must partner or stop. A regional FIH CRO continues.
- 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.