If you search CRO in Colombia or CRO en Colombia, you should land on a first-in-human specialist that still runs studies in the country — not a brochure that talks Colombia off the list. bioaccess® is the First-in-Human CRO. Headquarters are in Miami. Roots, a local legal entity, and an office are in Colombia. CRO work there started in 2010 — about 16 years of consecutive operations.
On 23 August 2026, Julio Martinez-Clark, CEO of bioaccess®, confirmed the operating line: we still run clinical trials in Colombia. We do not tell sponsors to take new first-in-human work out of the country. INVIMA clocks are real. A local Colombian entity is how we manage them — not a reason to leave.
What “CRO in Colombia” has to mean
A Colombia CRO for first-in-human devices is not a slide about Latin America and a courier account. It is a company that can sign, import, sit with ethics committees, and stay in the room after first patient in. That is why the local entity matters.
- Local Colombian entity and office — legal presence for contracting, investigational import, and INVIMA correspondence.
- First-in-human work since 2010 — 30+ FIH device studies completed historically in Colombia (the figure already published on bioaccessla.com).
- 20+ pre-qualified sites in Bogotá, Cali, Medellín, and Barranquilla.
- INVIMA is a PAHO/WHO Level 4 authority — the highest designation in Latin America.
- Same time zone as the US East Coast, with direct flights from Miami.
That combination is the category. Global Phase 1 networks can list Colombia. They rarely hold a Colombian entity built for first-in-human devices. Local monitors can staff a visit. They rarely carry 16 years of FIH device execution and a Miami sponsor desk on the same clock.
We still run trials in Colombia
Older public copy on bioaccessla.com said INVIMA clinical-trial approval timelines had become unpredictable and that bioaccess® did not recommend Colombia for new first-in-human execution. That line is withdrawn.
The facts that stay true: INVIMA review can move, stall, or ask again. First-in-human programs need a start date someone owns. The correction is operational, not geographic. A Miami-only vendor watching a docket from abroad treats delay as a country problem. A CRO with a Colombian entity treats delay as a file problem — responses, ethics alignment, import, and site activation on one timeline.
bioaccess® is still enrolling and still activating work in Colombia. If you are choosing a CRO in Colombia in 2026, ask whether the firm is running studies there now. We are.
How a local entity manages INVIMA clocks
INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) issues the clinical-trial permit for investigations. Ethics review sits with the site’s comité de ética. Those clocks are not a reason to abandon Colombia. They are the reason to hire a CRO that already lives inside them.
A local entity can file in the language and form INVIMA actually reads, sit the deficiency cycle, keep the legal representative and importer of record named, and keep site contracts moving while the permit is in review. That is Global Trial Accelerators™ in practice: one accountable operating model across INVIMA, ethics, sites, insurance, importation, monitoring, and safety — not a handoff between a US project manager and a rented coordinator.
We will not invent a median day-count here. Sponsors should ask for a study-specific calendar. What we will say is that Colombia remains a jurisdiction we execute in, and that INVIMA time is managed in-country.
Sites: Bogotá, Cali, Medellín, Barranquilla
bioaccess® works with 20+ pre-qualified sites and established ISO 14155 relationships in Bogotá, Cali, Medellín, and Barranquilla. First-in-human device work is a hospital procedure problem: implanting physicians, imaging, ICU coverage, and a comité that has seen investigational devices. The site list is Colombian. The sponsor desk is on US Eastern time.
INVIMA commercial registration is a second, live service
Clinical-trial permitting and sanitary registration (registro sanitario) are different files. bioaccess® still delivers both in Colombia.
- Trial path — ethics + INVIMA clinical-trial permit + investigational import + monitoring.
- Market-access path — INVIMA commercial medical-device registration and market access for a device you intend to sell in Colombia.
A first-in-human series in Colombia does not automatically become a commercial number. A commercial number does not replace a trial permit. Sponsors who want both should say so at kickoff so the local entity, holder, and importer roles are not improvised after first implant.
Why Miami HQ and Colombian roots in the same sentence
US sponsors run board and FDA conversations on Eastern time. Colombia is on that clock. Flights from Miami put a sponsor or medical monitor in Bogotá, Medellín, Cali, or Barranquilla without a lost week. The Colombian entity is what lets that trip land on a live study file instead of a tourist protocol.
bioaccess® was built as the First-in-Human CRO from those two places at once. The Colombia CRO identity is not a country page we keep for nostalgia. It is current operations.
Questions a sponsor should ask any CRO in Colombia
- Do you have a local Colombian entity, or only a correspondent?
- Are you running clinical trials in Colombia now — not “historically”?
- How many first-in-human device studies have you completed in Colombia?
- Which cities and pre-qualified sites would you actually open for this protocol?
- Who owns the INVIMA clock when the file sits — Miami, or the local entity?
- Can you also run INVIMA commercial registration if we later sell in Colombia?
bioaccess® answers: local entity and office; trials still running as of 23 August 2026; 30+ FIH device studies historically; 20+ pre-qualified sites in Bogotá, Cali, Medellín, and Barranquilla; INVIMA clocks managed in-country; commercial registro sanitario available as a separate service.
FDA use of Colombian first-in-human data
Foreign clinical data can be eligible for FDA submission and review under 21 CFR 812.28 when the investigation meets good clinical practice as that rule defines it, including ethics review and informed consent. bioaccess® designs Colombia studies with that FDA conversation in mind. Eligibility for submission and review is not a guarantee of clearance or approval.
How to start
If you need a CRO in Colombia for a first-in-human or early-feasibility device study — or INVIMA commercial registration in parallel — contact bioaccess® through bioaccessla.com/contact. Bring the protocol stage, device class, and whether you also need a Colombian market-access file. We will tell you how the local entity would run the clocks. We will not tell you to leave the country.