Advance Your Medical Device Sooner
Accelerated Medical Device Clinical Study Services in Latin America
Medical device clinical trials require high levels of experience, specialized knowledge, and flexibility. When you trust the outcome of your trial with us, you are leveraging a team of experts with a proven background of 20+ years in Medtech.
Our sole focus is managing the following studies through to success:
Pilot Studies
First-In-Human Studies (FIH)
Early-Feasibility Studies (EFS)
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:
Review and feedback on study documents to comply with country requirements.
Feasibility and selection of research site and principal investigator (PI).
Trial set-up, start-up, and approval (ethics committee and Ministry of Health).
Import permit and nationalization of investigational devices.
Subject recruitment campaigns.
Study project management and monitoring.
Advance Your Medical Device In
Colombia
