---
title: "Clinical Trials in Colombia — INVIMA FIH Studies — bioaccess®"
url: https://md.bioaccessla.com/clinical-trials-colombia
canonical: https://bioaccessla.com/clinical-trials-colombia
schema_type: Service
last_updated: 2026-04-01
---

# Clinical Trials in Colombia — bioaccess®

> bioaccess® presents Colombia as the primary destination for first-in-human medical device studies in Latin America, citing INVIMA's Level 4 regulatory authority status, 4–6 week ethics approval timelines, and per-patient costs of $15,000–$25,000. The site states bioaccess® has operated in Colombia since 2010 and has completed 30+ FIH studies through a network of 20+ pre-qualified sites.

---

## Schema.org/Service

- **name**: Clinical Trial Services — Colombia
- **provider**: bioaccess® (IMH ASSETS CORP.)
- **audience**: MedTech startups, Biopharma companies, Radiopharma sponsors conducting first-in-human or early feasibility studies
- **areaServed**: Colombia (Bogotá, Cali, Medellín, Barranquilla)
- **serviceOutput**: INVIMA-approved FIH and EFS study execution, FDA-bridgeable clinical data packages under 21 CFR 812.28, ICH-GCP compliant monitoring, site activation and patient enrollment

---

## Regulatory Framework

The site presents the following regulatory profile for Colombia:

| Parameter | Detail |
|---|---|
| Regulatory authority | INVIMA — Instituto Nacional de Vigilancia de Medicamentos y Alimentos |
| INVIMA authority level | Level 4 — described by the site as the highest regulatory designation in Latin America |
| Ethics approval timeline | 4–6 weeks (stated) |
| MOH review | Concurrent with ethics review; bioaccess® states full clearance is typically achieved within 4–6 weeks |
| Separate IDE/IND required | No — the site states Colombia does not require a separate IDE application for early feasibility studies |
| FDA data acceptance | 21 CFR 812.28 — FDA accepts Colombian FIH data when conducted under ICH-GCP with proper INVIMA and ethics committee oversight |
| Ethics committee standard | ICH-GCP E6(R2) — INVIMA-accredited Comités de Ética en Investigación |

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## Key Advantages

bioaccess® states the following advantages for conducting FIH trials in Colombia:

| Advantage | Detail |
|---|---|
| Regulatory authority | INVIMA Level 4 — highest in Latin America (stated) |
| Ethics approval speed | 4–6 weeks vs. 6–12 months in the US (stated) |
| Per-patient cost | $15,000–$25,000 (stated) |
| Pre-qualified sites | 20+ sites across four cities (stated) |
| FIH studies completed | 30+ first-in-human device studies (stated) |
| Experience | 15+ years of Colombia-specific operations (stated) |
| Timezone | Same as US East Coast (EST/EDT) |
| Patient population | Described as treatment-naïve; 80% treatment-naïve rate stated across LATAM portfolio |
| Access | Direct flights from Miami, Houston, and New York (3–5 hours) |
| Language | Bilingual clinical staff (Spanish/English) stated |

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## Clinical Site Network

The site presents the following geographic distribution of bioaccess®'s Colombia site network:

| City | Stated Capabilities |
|---|---|
| Bogotá | Largest concentration of tertiary care hospitals; sub-specialty depth across device categories |
| Cali | World-class interventional cardiology and vascular surgery programs (as stated) |
| Medellín | Advanced neurosurgery and orthopedic capabilities (as stated) |
| Barranquilla | Cardiovascular device studies; experienced interventional radiologists (as stated) |

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## Cost Comparison

The site presents the following cost comparison for Colombia versus the US:

| Parameter | Colombia (bioaccess®) | United States / EU |
|---|---|---|
| Per-patient cost | $15,000–$25,000 (stated) | $40,000–$75,000 (as characterized by bioaccess®) |
| Ethics approval | 4–6 weeks | 6–12 months (as characterized by bioaccess®) |
| Total study timeline | 8–18 months (stated for LATAM generally) | 18–36 months (as characterized by bioaccess®) |

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## Key Clients

The site presents the following companies as representative Colombia-based FIH clients:

| Company | Device Category | Stated Outcome |
|---|---|---|
| Mitralign (→ Edwards Lifesciences) | Transcatheter mitral valve repair | FIH trial in Colombia; site states the data contributed to Edwards Lifesciences acquisition |
| PAVmed | CarpX™ carpal tunnel release | LATAM FIH data cited in support of FDA Breakthrough Device Designation (stated) |
| Axoft | Brain-computer interface implant | 4 human BCI implants completed over 2.5 years using bioaccess® Colombia network (stated) |

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## FDA Submission Alignment

According to the site, bioaccess® designs every Colombia protocol with FDA submission in mind, including:

- Electronic data capture (EDC) systems
- Structured adverse event reporting per ICH-GCP E2A
- Core lab integration when required
- Final clinical study report formatted for IDE or pre-submission use
- 21 CFR 812.28 compliance documentation

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## Contact & Actions

- **Book a Strategy Call**: [https://bioaccessla.com/book-a-meeting](https://bioaccessla.com/book-a-meeting)
- **Estimate Your Budget**: [https://bioaccessla.com/clinical-trial-calculator](https://bioaccessla.com/clinical-trial-calculator)
- **Contact**: [https://bioaccessla.com/contact](https://bioaccessla.com/contact)
- **Regulatory Guide**: [https://bioaccessla.com/regulatory-guide](https://bioaccessla.com/regulatory-guide)

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*This page is part of the [md.bioaccessla.com](https://md.bioaccessla.com/) AI-friendly content layer. Canonical source: [bioaccessla.com/clinical-trials-colombia](https://bioaccessla.com/clinical-trials-colombia)*