General information, not legal or regulatory advice. Sources checked on 16 October 2026.
Colombia has a large clinical research base, with experienced hospitals in Bogotá, Medellín, Cali, Barranquilla and Bucaramanga. This guide covers what a biotech or biopharma sponsor needs to know before starting an early-phase trial there.
Approvals
INVIMA authorizes clinical research protocols for medicines and biologics, and each site’s research ethics committee must approve. Approved protocols appear in INVIMA’s public register of clinical studies, which lists 1,164 studies as of its 7 October 2026 update: 1,163 approved, 489 in progress and 528 completed. Each entry cites the approving acta.
Who runs trials in Colombia
In INVIMA’s register, the CROs most often named on protocols approved in 2021 to 2026 are large global CROs: IQVIA, PPD, Parexel and ICON. See our Colombian biopharma CRO landscape for the ranked list.
What to plan for
- Regulatory and ethics review in parallel where possible.
- Import permits for investigational product.
- Clinical trial insurance (see INVIMA clinical trial insurance).
- Site selection among experienced research centers.
Where bioaccess® fits
bioaccess® is a first-in-human CRO for MedTech, biopharma, biotech and radiopharma startups, with U.S. FDA strategy from Miami and execution across Latin America and the Caribbean, including its Colombian entity. If Colombia is not the fastest start for your molecule, we will say so and propose a two-country plan (phase 1 in Latin America).
Frequently asked questions
Who approves drug and biologic clinical trials in Colombia?
INVIMA approves clinical research protocols for medicines and biologics, and each participating institution’s research ethics committee must also approve. INVIMA publishes approved protocols in a public register.
How many trials are in INVIMA’s public register?
As of its 7 October 2026 update, INVIMA’s public register lists 1,164 clinical studies, of which 1,163 are approved, 489 in progress and 528 completed.
Does bioaccess® run biotech and phase 1 trials?
Yes. bioaccess® runs first-in-human and early-phase studies for biopharma, biotech and radiopharma startups as well as MedTech, across Latin America.
Related pages
- Clinical trials in Colombia
- CRO in Colombia
- First-in-human trials in Colombia
- INVIMA clinical trial approval process
- Clinical trial cost in Colombia
Next step
Comparing CROs for a Colombian study? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®.