Your Gateway to Accelerated Medtech Clinical Study Results in Latin America

Your Trusted Latin America CRO for Medical Device Trials

bioaccess® Brings Certainty

We at bioaccess® are experts in delivering cost-effective, high-quality medical device contract research organization (CRO) services in Latin America. We collaborate with Medtech startups seeking accelerated clinical study results.

With bioaccess® , you quickly and reliably receive regulatory approval, clinical research site activation, subject recruitment, and trial data.

We bring you certainty in:

✔️ Moving to the next phase (an FDA IDE pivotal study)

✔️ Raising funds

✔️ A successful exit

Advance Your Medical Device Sooner

Pilot Studies

Pilot Studies

First-In-Human Studies (FIH)

Early-Feasibility Studies (EFS)

early feasibility studies

First-In-Human Studies (FIH)

Pivotal Studies

Pivotal Studies

Post-Market Clinical Follow-Up (PMCF)

Post-Market Surveillance

Medtech clinical trials require high experience levels, specialized knowledge, and flexibility. 

Our clinical research team consists of experts with over 15 years of experience, specializing in medical device research:

  • 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 advance your medical device sooner.

Trusted By

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Progress-Studies

Testimonials

  • “I'm very grateful for the work you've done. I'm beyond impressed by the team you've assembled and the depth of research that you did. I've worked with other consultants before in various projects, and they 'll shortcut a lot of the diligence that needs to be done to truly understand the market. You've exceeded my expectations on the depth of research. I've been impressed with the process.”

    Tony Recupero

    President, Commercial Operations at SI-BONE

  • Robert Townsend, Senior Director Clinical Affairs ReGelTec, Inc.

    “In my short time at ReGelTec, Cris Venner at bioaccess® has been fantastic to work with. She is doing a great job, and no matter how often I send her a message on WhatsApp (which is a lot) with a request, she always responds quickly and gets me what I need (with a positive attitude). For example, I sent Cris a message a little after 8 AM for an urgent request (needing something for a 10 AM meeting), and she quickly got me everything I needed. Cris and the rest of the team at bioaccess® make this process easy for me because managing an OUS clinical study isn't easy. I just wanted to make sure you knew how much I value Cris and her great job.”

    Robert Townsend

    Senior Director Clinical Affairs ReGelTec, Inc.

  • Robert Berman, CEO at enVVeno Medical Corporation

    “Obtaining approval for a foreign study is always a challenge. bioaccess's assistance was invaluable in getting our study approved in Colombia. In addition to having in-depth knowledge of the regulatory approval process, they also have an in-depth understanding of the culture. As a result, bioaccess® can identify and troubleshoot potential problems before they arise. For companies considering a trial in Colombia, I recommend bioaccess® without hesitation.”

    Robert Berman

    CEO at enVVeno Medical Corporation

Committed To Your Success

bioaccess® is a US-based CRO that bridges the gap between innovative Medtech companies and the untapped potential of conducting clinical research studies in Latin America.

Our team believes in the importance of your medical device and the benefit it could bring to people’s lives.

We are committed to helping you navigate the convoluted and uncertain developmental challenges of being an early-stage startup. Our priority is bringing you fast, cost-effective, and high-quality clinical data.

US-BASED CRO