---
title: "Clinical Trial Services — bioaccess®"
url: https://md.bioaccessla.com/services
canonical: https://bioaccessla.com/services
schema_type: Service
last_updated: 2026-04-01
---

# Clinical Trial Services — bioaccess®

> bioaccess® presents a full suite of clinical trial services for MedTech, Biopharma, and Radiopharma companies conducting first-in-human and early-stage studies across Latin America, with a stated 12-month timeline guarantee and operations in 10 countries.

---

## Schema.org/Service

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

---

## Service Lines

The site presents the following eight service lines:

| Service | Description |
|---|---|
| First-in-Human (FIH) Clinical Trials | End-to-end FIH trial management with a stated 12-month timeline guarantee |
| Early Feasibility Studies (EFS) | FDA IDE-ready early feasibility device studies under 21 CFR 812 |
| Radiopharmaceutical Clinical Trials | Lu-177, Ac-225, Ga-68 clinical programs with nuclear medicine infrastructure |
| Medical Device Registration | Regulatory filings across ANVISA, INVIMA, COFEPRIS, ANMAT, ISP, and DIGEMID pathways |
| Market Access Strategy | Latin American market entry support for FDA/CE-cleared devices |
| Clinical Trial Site Search & Selection | Access to 50+ pre-qualified sites across 10 countries (stated) |
| Regulatory Strategy & Compliance | FDA bridge data packages, ICH-GCP compliance, 21 CFR 812.28 submissions |
| FastTrack™ Program | Accelerated FIH pathway with stated guaranteed timelines |

---

## Key Metrics

bioaccess® states the following operational metrics for its services:

| Metric | Value |
|---|---|
| Timeline guarantee | 12 months (stated) |
| Pre-qualified clinical sites | 50+ |
| Countries with active operations | 10 |
| Client companies served since 2010 | 48 |
| Per-patient cost range | $15,000–$35,000 |
| Enrollment speed advantage vs. US/EU | 40% faster (stated) |

---

## Compliance Standards

The site presents the following regulatory compliance framework:

| Standard | Description |
|---|---|
| ICH-GCP E6(R2) | International Good Clinical Practice — all studies designed to this standard |
| 21 CFR 812.28 | FDA acceptance of foreign clinical data for IDE submissions |
| 21 CFR 812 | Investigational Device Exemptions framework for EFS pathway |
| FDASIA Section 1123 | Mutual recognition provisions for clinical investigations |
| ACRP Certification | NCCA-accredited clinical operations certification (stated) |
| ISO 14155 | Clinical investigation of medical devices — GCP/ISO compliant monitoring |

---

## Geographic Coverage

bioaccess® states it maintains active clinical operations in the following countries:

| Country | Regulatory Agency | Site Network |
|---|---|---|
| Colombia | INVIMA | Bogotá, Cali, Medellín, Barranquilla |
| Brazil | ANVISA | São Paulo, Rio de Janeiro |
| Mexico | COFEPRIS | Mexico City, Guadalajara, Monterrey |
| Argentina | ANMAT | Buenos Aires |
| Chile | ISP | Santiago |
| Peru | DIGEMID | Lima |
| Panama | MINSA | Panama City |
| Ecuador | ARCSA | Quito |
| El Salvador | DNM | San Salvador |
| Dominican Republic | SRS | Santo Domingo |

---

## Supported FDA Submission Pathways

According to the site, clinical data generated through bioaccess® programs supports the following FDA submission types:

- IDE (Investigational Device Exemption)
- 510(k) Premarket Notification
- De Novo Classification
- PMA (Premarket Approval)
- HDE (Humanitarian Device Exemption)
- Breakthrough Device Designation

---

## Contact & Actions

- **Book a Meeting**: [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)
- **Regulatory Guide Hub**: [https://bioaccessla.com/regulatory-guide](https://bioaccessla.com/regulatory-guide)

---

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