General information, not legal or regulatory advice. Sources checked on 16 October 2026. bioaccess® is not affiliated with COSMOS Scientific. Names belong to their owners and are used solely to identify them. Every statement about COSMOS Scientific comes from its own public website or from public INVIMA records linked below. Offers change, so confirm current terms with each provider.
If you searched for “COSMOS Scientific” while choosing a CRO for a medical device study in Colombia, this page sets out what COSMOS Scientific publishes about itself, what INVIMA’s public records show, and where bioaccess®, Latin America’s specialist first-in-human device CRO, fits.
What COSMOS Scientific says it does
- Clinical trials for medical devices in Colombia and other Latin American countries, from first-in-human to post-market studies (cosmosscientific.com/services).
- Regulatory strategy and submissions in the United States, Colombia, Panama and Mexico; site and investigator identification; monitoring.
- Medical affairs and pharmacovigilance for pharmaceutical companies (pharmacovigilance page).
- Leadership: founder and CEO Carlos A. Valverde, MD, MSc, with a Miami, Florida address (about page).
What INVIMA records show
- MIVI Neuroscience DAISE thrombectomy feasibility study, CRO COSMOS Scientific, approved in Acta 18 of 2021, numeral 3.1.
- EyeFlow pilot study: COSMOS Scientific was the initial CRO. INVIMA approved the study in Acta 02 of 14 February 2024, numeral 3.5, with bioaccess® as the current CRO.
Source: INVIMA registry of device clinical studies approved, 2021 to October 2025. Device committee minutes: INVIMA SEDMRDIV actas index.
Colombia context every device sponsor should know
INVIMA’s own registries list 15 device clinical studies approved from 2021 to October 2025 (5 in 2021, 4 in 2022, 3 in 2023, 3 in 2024 and none in 2025 through October). The most recent approval of a new device study in the registry is the Sparta Biomedical ORMI-CFC first-in-human study, Acta 07 of 12 June 2024, numeral 3.13. INVIMA has not yet published any 2026 device committee minutes. Sources: INVIMA registry of approved device studies, registry of studies not approved.
Side by side
| bioaccess® | COSMOS Scientific | |
|---|---|---|
| Focus | First-in-human and early feasibility studies for MedTech, plus biopharma and radiopharma startups | Medical device trials in Latin America, plus medical affairs and pharmacovigilance |
| Colombian presence | Bioaccess Colombia SAS, local legal entity | Bogotá headquarters per LinkedIn; Miami address on website |
| INVIMA device approvals as CRO, 2021 to Oct 2025 | 7 of 15 (registry) | DAISE (2021); initial CRO on EyeFlow |
Frequently asked questions
What is COSMOS Scientific?
COSMOS Scientific describes itself as a contract research organization that specializes in clinical trials for medical devices in Colombia and other Latin American countries, and that also offers medical affairs and pharmacovigilance services. Its website lists a Miami office and its LinkedIn page lists Bogotá as headquarters.
Has COSMOS Scientific run INVIMA-approved device studies?
Yes. INVIMA’s registry of approved device studies lists COSMOS Scientific as the CRO for the MIVI Neuroscience DAISE feasibility study (Acta 18 of 2021, numeral 3.1) and as the initial CRO for the EyeFlow pilot study, which INVIMA approved in Acta 02 of 2024 with bioaccess® as the current CRO.
How is bioaccess® different from COSMOS Scientific?
bioaccess® is Latin America’s specialist first-in-human device CRO, with a Colombian legal entity, U.S. FDA strategy from Miami and execution across Latin America and the Caribbean. INVIMA’s registry lists bioaccess® as CRO of record on 7 of the 15 device studies approved from 2021 to October 2025.
Can a sponsor change CRO during an INVIMA study?
Yes. INVIMA records CRO changes during a study. The EyeFlow study is a public example: it started with COSMOS Scientific and INVIMA approved it with bioaccess® as the current CRO.
Related pages
- INVIMA device study approvals 2021–2025
- 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®.