May 26, 2025

In this episode, we speak with Julio Martinez-Clark, CEO and co-founder of Bioaccess, a contract research organization helping Medtech and Biopharma startups slash months off their clinical timelines. With a focus on Latin America, Bioaccess enables early feasibility and first-in-human trials to be conducted faster, more affordably, and with high-quality data suitable for FDA and EU submissions. Julio shares how their global site network—built over 20 years—helps startups navigate regulatory hurdles, reduce costs, and de-risk innovation, all while improving patient lives in emerging markets.

This episode is sponsored by Black Swan IP

Top 3 Takeaways:

•   “The sites and IRBs in Latin America follow international ICH-GCP guidelines—Good Clinical Practice standards set by the World Health Organization. If you're a professional in clinical research, these are the standards you adhere to. As a sponsor, it's your responsibility to ensure that the sites you select, after rounds of interviews and vetting, comply with ICH-GCP. There's also a new development in the region: the Global Clinical Site Certification, an organization based in London that accredits clinical research sites internationally. They're expanding across the Americas, and countries like Colombia and Panama have been especially receptive. For example, we’re currently working on certifying CVAC, a site network in Panama.”
• For FDA market clearance, sponsors typically need a large, U.S.-based pivotal study. But the FDA may accept up to 30% of that data from international sites—if it follows ICH-GCP standards. First-in-human trials in places like Colombia or Panama can help demonstrate safety and efficacy, supporting an FDA IDE application for a pivotal U.S. study.
• Many FDA-approved therapies never reach Latin America, simply because manufacturers focus on larger markets like the U.S., Europe, or Japan. Clinical trials provide patients in Latin America with early access to innovative treatments they might otherwise never receive.

0:45 Do you want to introduce yourself better than I just did?

1:30 Why is Latin America better for clinical trials

4:15 How does the speed and cost compare to the US?

6:30 What standard of cleanliness, ethics, and quality can we expect in a country like Panama?

8:45 What kind of capabilities are in these countries?

10:15 Axsoft and Paul LeFloch, previous Neural Implant Podcast guests, utilized your services, can you talk more about their study?

14:15 What was the timeline of that study selection all the way to the end of the study?

15:30 What kind of Institutional Review Boards look over the ethics? Are they internationally recognized?

16:15 Sponsorship by Black Swan IP

20:15 Could you also use this for FDA approval?

 22:45 Do you want to talk about the willingness of the patients in Latin America to take part in these trials?

29:45 When should medical device developers reach out to you?

33:30 Is there anything else that we didn't talk about that you wanted to mention?