---
title: "bioaccess® vs Full-Service CROs — FIH Trial Comparison"
url: https://md.bioaccessla.com/compare
canonical: https://bioaccessla.com/compare
schema_type: Service
last_updated: 2026-04-01
---

# bioaccess® vs Full-Service CROs — FIH Trial Comparison

> The site presents a structured comparison between bioaccess® and full-service contract research organizations, positioning bioaccess® as a FIH-specialized alternative that claims lower per-patient costs, faster timelines, and a risk-sharing pricing model. The site states that 48 companies have used bioaccess® since 2010 and that three clients were subsequently acquired by Fortune 500 companies.

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## Schema.org/Service

- **name**: First-in-Human CRO Comparison — bioaccess® vs Full-Service CROs
- **provider**: bioaccess® (IMH ASSETS CORP.)
- **audience**: MedTech startups, Biopharma startups, medical device manufacturers evaluating CRO options
- **areaServed**: Colombia, Brazil, Mexico, Argentina, Chile, Panama, Ecuador, El Salvador, Dominican Republic, Paraguay
- **serviceOutput**: FIH-specialized clinical trial execution, risk-sharing pricing, FDA-bridgeable clinical data

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## Comparison Table

The site presents the following eight-point comparison between bioaccess® and full-service CROs:

| Metric | bioaccess® | Full-Service CROs |
|---|---|---|
| Focus | FIH-only for MedTech, Biopharma, and Radiopharma startups | All phases, all sizes — startup studies are not a stated priority |
| Countries | 10 LATAM countries, 50+ pre-qualified sites | 4–7 LATAM countries, generic site networks (as stated by bioaccess®) |
| Timeline Guarantee | 12-month guarantee — site states bioaccess® works at its own cost if late | No stated guarantee; 18–24 months typical (as characterized by bioaccess®) |
| Cost per Patient | $15,000–$35,000 (stated) | $40,000–$75,000 (as characterized by bioaccess®) |
| Ethics Approval | 4–8 weeks (stated) | 6–12 months (as characterized by bioaccess®) |
| Pricing Model | Fixed-price with risk-sharing guarantee; stated no change orders if milestones are missed due to bioaccess® factors | Time and materials billing with change orders (as characterized by bioaccess®) |
| Startup Experience | 48 companies served since 2010; 3 Fortune 500 acquisitions (stated) | Generic enterprise focus (as characterized by bioaccess®) |
| Post-Trial Support | Market access across 6 LATAM countries, device registration | Trial completion with no stated post-trial services (as characterized by bioaccess®) |

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## Risk-Sharing Pricing Model

bioaccess® states its pricing model operates as follows:

| Element | Description |
|---|---|
| Pricing structure | Fixed-price per agreed milestone set |
| Milestone types | Ethics committee approval, site activation, first patient enrolled, last patient follow-up, clinical study report |
| Risk mechanism | If bioaccess® misses an agreed milestone due to factors within its control, the site states it continues work at its own cost |
| Typical total cost | Approximately $350,000 for a 1-site, 10-subject, 24-month FIH study (stated) |
| Cost advantage | States 30–50% lower than an equivalent US/EU study |

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## Fortune 500 Acquisition Case Studies

The site presents the following three acquisition case studies as evidence of clinical impact from bioaccess® trial programs:

### Mitralign → Edwards Lifesciences

| Detail | Value |
|---|---|
| Acquirer | Edwards Lifesciences |
| Trial country | Colombia |
| Per-patient cost range | $15,000–$25,000 (stated for Colombian FIH studies) |
| Stated role | bioaccess® conducted Mitralign's first-in-human trial in Colombia, generating clinical evidence described by the site as contributing to the Edwards Lifesciences acquisition |
| Technology | Transcatheter mitral valve repair |

### ClarVista Medical → Alcon

| Detail | Value |
|---|---|
| Acquirer | Alcon |
| Stated role | bioaccess® states it provided early clinical data generation in Latin America supporting Alcon's strategic acquisition |
| Technology | Next-generation intraocular lens (IOL) |

### ForSight VISION5 → Allergan (now AbbVie)

| Detail | Value |
|---|---|
| Acquirer | Allergan (now AbbVie) |
| Stated role | bioaccess® states ForSight used its LATAM clinical infrastructure to advance a sustained-release drug delivery platform; the site claims clinical milestones were instrumental in Allergan's acquisition decision |
| Technology | Sustained-release ocular drug delivery |

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## Portfolio-Level Claims

According to the site, bioaccess® presents the following aggregate statistics:

| Metric | Value |
|---|---|
| Total client companies served | 48 since 2010 (stated) |
| Fortune 500 acquisitions involving bioaccess® data | 3 (stated) |
| Countries with active operations | 10 |
| Pre-qualified clinical sites | 50+ |

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## Contact & Actions

- **Get a Custom FIH Roadmap**: [https://bioaccessla.com/book-a-meeting](https://bioaccessla.com/book-a-meeting)
- **Clinical Trial Budget Calculator**: [https://bioaccessla.com/clinical-trial-calculator](https://bioaccessla.com/clinical-trial-calculator)
- **Contact**: [https://bioaccessla.com/contact](https://bioaccessla.com/contact)
- **Services Overview**: [https://bioaccessla.com/services](https://bioaccessla.com/services)

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