Advance Your Medical Device Sooner

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 20+ years in Medtech.

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

  • Early-Feasibility Studies (EFS)

  • First-In-Human Studies (FIH)

  • Pilot Studies

  • Pivotal Studies

  • Post-Market Clinical Follow-Up Studies (PMCF)

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 (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).