We at bioaccess™ are experts in delivering cost-effective and high-quality CRO services in Latin America

We partner with Medtech startups seeking accelerated early-feasibility (EFS) or first-in-human (FIH) clinical study results. With bioaccess™, you quickly and reliably receive regulatory approval, clinical research site activation, subject recruitment, and trial data.



Early Feasibility Studies (EFS), First-In-Human (FIH) Medical Device Clinical Trial Services in Latin America

We are a US-based contract research organization (CRO) that focuses on helping Medtech companies conduct their clinical research studies in Colombia and other countries in Latin America . We can assist you with the search, site selection, and approval of your planned early-stage /early-feasibility/first-in-man (FIM)/first-in-human (FIH)/proof-of-concept/clinical trial in Colombia. Read more about us here.

Our clinical trial services include:

  • Study design (e.g., protocol writing, investigator's brochure, patient consent form, case report form)

  • Investigator/site selection

  • Start-up and approval (Institutional review board (IRB)/ethics committee (EC) and Ministry of Health/regulatory (INVIMA) submission, creation of the study budget, and execution of the clinical trial agreement)

  • Import license, nationalization of investigational devices, and storage.

  • Project management

  • Study monitoring

  • Patient recruitment campaigns (i.e., Facebook, Instagram). Read more.


Colombia's Hospitals Rank as the Best in Latin America


Testimonials


CenterWatch Weekly's article on our work in Colombia (under our former name Interventional Concepts).

CenterWatch Weekly's article on our work in Colombia (under our former name Interventional Concepts).