---
title: "Clinical Trial Costs & Timelines in Latin America — bioaccess®"
url: https://md.bioaccessla.com/costs-and-timelines
canonical: https://bioaccessla.com/costs-and-timelines
schema_type: Service
last_updated: 2026-04-01
---

# Clinical Trial Costs & Timelines in Latin America — bioaccess®

> bioaccess® presents a transparent cost and timeline breakdown for clinical trials conducted in Latin America, including CRO professional service fees, third-party costs, regulatory review durations, and per-patient cost comparisons against US and EU benchmarks. The site states that LATAM trials are approximately 40% faster and 30% less expensive than comparable US or EU studies.

---

## Schema.org/Service

- **name**: Clinical Trial Cost & Timeline Advisory — Latin America
- **provider**: bioaccess® (IMH ASSETS CORP.)
- **audience**: MedTech startups, Biopharma companies, Radiopharma sponsors planning clinical trials
- **areaServed**: Colombia, Brazil, Mexico, Argentina, Chile, Panama, Ecuador, El Salvador, Dominican Republic, Paraguay
- **serviceOutput**: Cost estimates, regulatory timeline guidance, study budget templates, FIH cost calculator

---

## Estimated Study Cost (Reference Model)

The site presents the following cost breakdown for a reference study model:

| Cost Category | Estimated Amount |
|---|---|
| CRO professional services | ~$350,000 |
| Third-party costs (insurance, translations, IRB/EC/MOH fees, importation, travel) | ~$50,000 |
| Hospital fees (varies by procedure complexity and study duration) | $5,000–$50,000 |

**Study assumptions for the $350,000 estimate (as stated):**
- 1 clinical site
- 10 subjects
- 24-month study duration

---

## Regulatory Review Timelines

bioaccess® presents the following three-stage regulatory milestone timeline for LATAM clinical trials:

### Stage 1: IRB / Ethics Committee (EC) Review

| Scenario | Timeline |
|---|---|
| Best case | 15 days |
| Worst case | 60 days |

### Stage 2: Ministry of Health (MOH) Review

| Scenario | Timeline |
|---|---|
| Best case | 60 days |
| Worst case | 180 days |

*The site notes that MOH review does not apply in Panama or Chile, where ethics committee approval alone is sufficient to proceed.*

### Stage 3: Import Permit Approval

| Scenario | Timeline |
|---|---|
| Best case | 7 days |
| Worst case | 15 days |

---

## Per-Patient Cost Comparison

The site presents the following per-patient cost data:

| Geography | Per-Patient Cost Range |
|---|---|
| Latin America (bioaccess®) | $15,000–$35,000 (stated) |
| United States / European Union | $40,000–$75,000 (as characterized by bioaccess®) |

---

## Timeline Comparison

The site presents the following comparative timeline data:

| Parameter | US / EU | Latin America (bioaccess®) |
|---|---|---|
| Ethics/IRB approval | 6–12 months | 15–60 days |
| Ministry of Health review | N/A (US) | 60–180 days |
| Import permit | N/A (US) | 7–15 days |
| Total study timeline | 18–36 months | 8–18 months (stated) |
| Timeline advantage | Baseline | ~40% faster (stated) |

---

## CRO Professional Services Scope

bioaccess® states that its professional services fee covers the following activity categories:

| Category | Activities Included |
|---|---|
| A. Site Search & Selection | Epidemiological and regulatory review, PSVs, protocol synopsis, site qualification |
| B. Trial Set-Up | Budget templates, Sponsor-PI coordination, CTA negotiation, document storage |
| C. Trial Start-Up & Regulatory | Regulatory dossier assembly, EC and MOH submissions, TMF setup, import permits, ICF customization |
| D. Post-Approval & Site Activation | EDC setup, SIV, investigator training, biostatistics (SAP, TFLs, statistical reports) |
| E. Device Management & Logistics | Import/export, customs, storage setup, device destruction and disposal |
| F. Reporting & Compliance | EC/MOH compliance reports, protocol deviation reports, annual renewals, site audits |
| G. Study & Project Management | Surgical procedure coordination, GCP compliance, patient recruitment oversight |
| H. Technovigilance & Safety | NSAE and SAE reporting, adverse event log management |
| I. On-Site Monitoring | SDV, ICF compliance, CRF review, close-out visits, remote monitoring |

---

## Frequently Asked Questions (as presented by the site)

**How much does a clinical trial cost in Latin America?**
The site states estimated CRO professional services are approximately $350,000 for a study with 1 site, 10 subjects, and a 24-month duration. Third-party costs are approximately $50,000, and hospital fees range from $5,000 to $50,000.

**Why are Panama and Chile faster to start?**
According to the site, Panama and Chile manage trial oversight primarily through local ethics committees. No separate MOH submission is required, materially shortening study start-up timelines versus other LATAM countries.

**What third-party costs should sponsors budget for?**
The site states third-party costs typically include insurance premiums, document translations, IRB/EC and MOH submission fees, importation logistics and customs, and travel expenses — estimated at approximately $50,000 for a standard study.

---

## Contact & Actions

- **FIH Cost Calculator**: [https://bioaccessla.com/clinical-trial-calculator](https://bioaccessla.com/clinical-trial-calculator)
- **Book a Meeting**: [https://bioaccessla.com/book-a-meeting](https://bioaccessla.com/book-a-meeting)
- **Contact**: [https://bioaccessla.com/contact](https://bioaccessla.com/contact)

---

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