Accelerated
Medical Device
Clinical Study
Services in Latin America

Medical device clinical trials require high experience, specialized knowledge, and flexibility. When you trust the outcome of your trial with us, you leverage a team of experts with a proven background of 15+ years in Medtech.

Our sole focus is managing the following studies through to success:

• First-In-Human Studies (FIH)
• Early-Feasibility Studies (EFS)
• Pilot Studies
• Pivotal Studies
  
• Post-Market Surveillance
  

bioaccess® has the expertise and customized approach you need to navigate your company towards an acquisition.

Our Service Capabilities Include:

• Feasibility and selection of research site and principal investigator (PI).
• Review and feedback on study documents to comply with country requirements.
• Trial set-up, start-up, and approval (institutional review board, ethics committee and health ministry).
• Import permit and nationalization of investigational devices.
• Study project management and monitoring.
• Reporting (study status, inventory, serious and non-serious adverse events).