---
title: "First-in-Human (FIH) Clinical Trial CRO — bioaccess®"
url: https://md.bioaccessla.com/first-in-human-cro
canonical: https://bioaccessla.com/first-in-human-cro
schema_type: Service
last_updated: 2026-03-31
---

# First-in-Human Clinical Trial CRO

> bioaccess® presents itself as the only CRO in Latin America purpose-built exclusively for first-in-human (FIH) clinical trials for MedTech, Biopharma, and Radiopharma startups.

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## Schema.org/Service

- **name**: First-in-Human Clinical Trial Services
- **provider**: bioaccess® (IMH ASSETS CORP.)
- **audience**: MedTech startups, Biopharma startups, Radiopharma startups, medical device manufacturers
- **areaServed**: Colombia, Brazil, Mexico, Argentina, Chile, Panama, Ecuador, El Salvador, Dominican Republic, Paraguay
- **serviceOutput**: FDA-bridgeable clinical data, ICH-GCP compliant study execution, study startup & site activation, patient enrollment & retention, clinical monitoring, data management & biostatistics

---

## Key Differentiators

bioaccess® states the following differentiators for its FIH program:

| Differentiator | Detail |
|---|---|
| FIH-only focus | The site states bioaccess® is the only CRO built exclusively around first-in-human trials |
| 12-month study startup guarantee | Site activation within 12 months (stated) |
| 40% faster timelines | Compared to US/EU benchmarks (stated) |
| 30% lower per-patient costs | $15K–$35K vs. $40K–$75K in US/EU (stated) |
| 50+ pre-qualified clinical sites | Across 10 Latin American countries |
| ACRP-certified team | NCCA-accredited clinical operations certification |

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## Regulatory Compliance & FDA Acceptance

bioaccess® states that clinical data generated through its LATAM FIH programs is accepted by the FDA under:

- **21 CFR 812.28** — Acceptance of foreign clinical study data for IDE submissions
- **FDASIA Section 1123** — Mutual recognition provisions for clinical investigations
- **ICH-GCP** — International Conference on Harmonisation Good Clinical Practice compliance
- **Supported FDA pathways**: IDE, 510(k), De Novo, PMA, HDE, Breakthrough Device Designation

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## FIH Study Activities

The site presents the following included activities in a typical FIH engagement:

1. **Regulatory strategy** — Country selection, regulatory pathway mapping
2. **Ethics/IRB submission** — 4–8 week approval timeline (stated)
3. **Site selection & activation** — From 50+ pre-qualified ICH-GCP sites
4. **Clinical trial agreements** — CTA negotiation and execution
5. **Clinical trial insurance** — Policy procurement ($5M–$10M coverage)
6. **Patient recruitment & enrollment** — Access to 80% treatment-naïve populations (stated)
7. **Clinical monitoring** — On-site and remote monitoring per ICH-GCP
8. **Data management** — EDC setup, data cleaning, biostatistical analysis
9. **Regulatory closeout** — Final study reports, FDA bridge data packages

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## Use Cases

bioaccess® states its FIH services apply to:

- First-in-human medical device implants
- First-in-human drug/biologic dosing studies
- Early feasibility studies (EFS) under 21 CFR 812
- Breakthrough device clinical evidence generation
- Pre-IDE and pre-submission clinical programs
- Radiopharmaceutical first-in-human dosimetry studies

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## Proof Points & Case Studies

The site presents the following case studies as evidence:

| Company | Outcome (as stated by bioaccess®) |
|---|---|
| Axoft | 4 brain-computer interface implants in 2.5 years; seed-stage to clinical |
| Newrotex | World's first silk nerve guide human implant; 2-week regulatory approval |
| PAVmed | CarpX™ device; FDA Breakthrough Device Designation using LATAM data |
| Avantec Vascular | Sangria™ venous remodeling system; FIH completed in El Salvador |
| Portfolio-wide | 15+ startup funding rounds supported with clinical milestones (stated) |

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## Contact

- **Book a FIH Consultation**: [https://bioaccessla.com/book-a-meeting](https://bioaccessla.com/book-a-meeting)
- **Clinical Trial Calculator**: [https://bioaccessla.com/clinical-trial-calculator](https://bioaccessla.com/clinical-trial-calculator)

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