Your Gateway to Accelerated Medtech Clinical Study Results
Latin America’s leading contract research organization (CRO) provides world-class clinical research services, rapidly advancing your medical device from pilot study to commercialization
bioaccess® Brings Certainty
We at bioaccess® are experts in delivering cost-effective, high-quality medical device 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
Early-Feasibility Studies (EFS)
First-In-Human Studies (FIH)
Pivotal Studies
Post-Market Clinical
Follow-Up (PMCF)
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:
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 advance your medical device sooner.
Trusted By
Testimonials
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“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
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![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.
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![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 an in-depth knowledge of the regulatory approval process, they also have a deep 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.
