Accelerate FDA Submissions by 6–12 Months Using Latin America’s Streamlined Clinical Pathways

Leverage 40% faster regulatory approvals and 50% quicker patient recruitment vs. US/EU sites

bioaccess® Helps You Exit Faster with Latin America’s Unmatched Trial Velocity

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

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bioaccess® fast-tracks medical device trials in Latin America via rapid approvals and lower costs

Regulatory Sprint

Latin American agencies like Panama’s MINSA and Dominican Republic’s CONABIOS approve early feasibility studies in 2–3 months versus 6–12 months in the US, accelerating IDE submissions

Pilot Studies

Unlike generic CROs, bioaccess® combines Latin America’s speed/cost advantages with deep regulatory expertise to de-risk trials for startups prioritizing time-to-market and investor-ready outcomes.

Early-Feasibility Studies (EFS)

First-In-Human Studies (FIH)

Patient Recruitment at Warp Speed

Access treatment-naive populations in cardiology, orthopedics, and neurology, with enrollment completed 50% faster than US/EU benchmarks

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Site Activation in <8 Weeks

bioaccess®’s pre-qualified network of 50+ sites across Latin America eliminates 3–4 months of site qualification delays common in Western trials.

Trusted By

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
“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.
“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 the only 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.

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