bioaccess® — The First CRO Specifically Designed for First-in-Human Clinical Trials Healthcare startups creating innovative MedTech devices, Biopharma treatments, and Radiopharma solutions encounter a significant obstacle: the need to produce clinical data that investors and buyers require before their funding depletes. Traditional CROs cater to large pharmaceutical companies conducting Phase III large-scale trials. They tend to be slow, charge high fees, and often overlook early-stage startups. Founded in 2010, bioaccess® aims to address this issue specifically. We are the first and only contract research organization designed exclusively for first-in-human clinical trials targeting healthcare startups. Our Clients: We assist startups in the seed to growth stages within MedTech, Biopharma, and Radiopharma — those needing human proof-of-concept data to reach their next objectives. What Sets Us Apart: Our unique Innovation Runway is the first clinical development pathway solely for FIH trials, enabling us to achieve ethics approval in just 4–8 weeks, shorten project timelines by 40%, and cut costs by 30% compared to traditional US/EU-only methods. All studies are fully compliant with ICH-GCP, ensuring FDA/EMA-ready data without requiring any revisions. We operate in 10 countries across Latin America. Since our inception in 2010, bioaccess® has successfully propelled over 58 companies from seed-stage to Fortune 500 MedTech. Our headquarters are located in Miami, FL. For more information, visit bioaccessla.com.