--- title: "About bioaccess® — The First-in-Human CRO — U.S. & Latin America" url: https://md.bioaccessla.com/about canonical: https://bioaccessla.com/about schema_type: Organization last_updated: 2026-04-28 --- # About bioaccess® — The First-in-Human CRO — U.S. & Latin America > bioaccess® is The First-in-Human CRO built for the United States and Latin America. The company anchors first-in-human clinical research on U.S. regulatory strategy (FDA Pre-Sub, IND/IDE) and executes across Latin America so MedTech, Biopharma, and Radiopharma startups can reach regulator-ready clinical milestones faster, with lower effort and lower per-patient cost. --- ## Company Overview - **Legal entity**: IMH ASSETS CORP. - **Founded**: 2010 - **Headquarters**: 1200 Brickell Ave., Suite 1950 #1034, Miami, FL 33131, USA - **Clients**: 50+ client companies served since founding, out of hundreds consulted - **Clinical sites**: 50+ pre-qualified sites across Latin America - **FIH model**: U.S. regulatory anchoring plus Latin American execution --- ## Leadership - **Julio Martinez-Clark** — CEO - **Dr. Pedro Martinez-Clark, MD** — Co-Founder, Chief Medical Officer - **Dr. William O'Neill, MD** — Co-Founder, Medical Director - **John Myklusch** — Chief Financial Officer - **Monica C. Mora** — Chief Operating Officer --- ## Featured Leadership ### John Myklusch — Chief Financial Officer ![John Myklusch, Chief Financial Officer at bioaccess®](/images/team/john-myklusch.jpg) *CPA · CEPA · Principal, AmbitionCFO* John Myklusch leads finance and strategic planning at bioaccess®. A Certified Public Accountant (CPA) and Certified Exit Planning Advisor (CEPA), John brings senior finance leadership experience as Principal at AmbitionCFO, where he advises growth-stage companies on capital strategy, financial operations, and value creation. At bioaccess®, he oversees the financial discipline behind a 50+ first-in-human program portfolio across ten Latin American markets, supporting medtech, biopharma, and radiopharma sponsors with the financial structuring required for cross-border clinical execution. ### Monica C. Mora — Chief Operating Officer ![Monica C. Mora, Chief Operating Officer at bioaccess®](/images/team/monica-mora.jpg) *Operations & Regulatory Strategy · LATAM Medtech CRO* Monica C. Mora leads operations at bioaccess®, overseeing the execution layer behind first-in-human clinical trials across ten Latin American markets. She specializes in the operational complexity that medical-device clinical research requires — site qualification, regulatory strategy, logistics, and compliance across Colombia, Brazil, Mexico, Panama, Argentina, Chile, and the broader region. Monica works closely with sponsors from feasibility through study close-out, ensuring that the ICH-GCP compliance and FDA-bridgeable data standards bioaccess® is known for are delivered consistently across every site and study. Based in Orlando, Florida. --- ## Clinical Research Team Two physician + ACRP-certified clinical professionals on staff. Per a 2026 audit of public Latin American CRO listings, no major LATAM CRO (ICON, Cohortias, Activa, others) publicly advertises an ACRP-certified clinical research professional. bioaccess® has two — both medical doctors from Universidad de los Andes, one of whom sits on the ACRP-CP Global Exam Committee that defines the certification standard. ### Juan C. Cuya, MD, ACRP-CP, MSc Epidemiology, MPH, MSc HIV — Senior Clinical Trial Associate ![Juan C. Cuya, Senior Clinical Trial Associate at bioaccess®](/images/team/juan.jpg) *Senior Clinical Trial Associate · Member, ACRP-CP Global Exam Committee (2025–2027)* Medical Doctor from Universidad de los Andes — one of the top universities in Latin America. ACRP-certified clinical trial associate and a sitting member of the ACRP-CP Global Exam Committee (Jan 2025 – Dec 2027) — he helps write the certification that defines the standard for clinical research professionals worldwide. Holds an MSc in Epidemiology and an MPH from Universidad de los Andes, plus an MSc in HIV from Universidad Rey Juan Carlos (Spain), and completed a research internship in Planetary Health at Rijksuniversiteit Groningen. Member of the Research Ethics Committee at BioXcellerator Colombia. Faculty at Universidad de los Andes School of Medicine since 2021. Prior consultant for the Colombian Ministry of Health, IETS, PAHO, and UNICEF. Co-author in The Journal of Vascular Access (2021). Languages: Spanish (native), English, Italian, Portuguese. ### Sergio Adair Alvarado Garzón, MD, ACRP-CP — Senior Clinical Research Associate ![Sergio Adair Alvarado Garzón, Senior Clinical Research Associate at bioaccess®](/images/team/sergio.jpg) *Senior Clinical Research Associate · Physician + ACRP-certified clinical operator* Medical Doctor from Universidad de los Andes and ACRP-certified Senior Clinical Research Associate at bioaccess® since February 2022 (ACRP certificate valid through 31-May-2026). Brings a physician's clinical lens to every protocol, with hands-on execution across cardiovascular, ophthalmology, and surgical-device studies in Latin America. Concurrent General Practitioner at Caja Colombiana de Subsidio Familiar (COLSUBSIDIO) since 2021 — a dual physician + clinical-operations track that translates directly into stronger site selection, sharper investigator dialogue, and cleaner protocol execution in the field. Day-to-day accountability for site monitoring, source-data verification (SDV), and Trial Master File management across active LATAM studies. ICH-GCP E6(R3) and ISO 14155 trained; cross-qualified on Greenlight Guru Clinical EDC and Sponsor-provided platforms. Prior medical training at Fundación Santa Fe de Bogotá and Novartis. Languages: Spanish (native), English (C2 listening · C1 reading, speaking, writing), German B2. ### Leonardo Andrés Rueda — Senior Clinical Project Manager ![Leonardo Andrés Rueda, Senior Clinical Project Manager at bioaccess®](/images/team/leonardo.jpg) *Senior Clinical Project Manager · LATAM FIH program lead* Single accountable owner for First-in-Human (FIH) and early-phase medical-device clinical trials across Central and South America. 5+ years of clinical-trial experience plus three years at IQVIA in Durham, NC (Dec 2021 – May 2024) bringing multinational-CRO project discipline back to bioaccess® as a returning alumnus. Manages the full lifecycle — study start-up, site activation, enrollment, data collection, and close-out — under ICH-GCP E6(R3), ISO 14155, and INVIMA, ANVISA, CECMED, DIGEMID, and ISP frameworks. ACRP-CP candidate (expected completion Q4 2026). GCP certified through 16-Oct-2027. M.S. Engineering Management and B.S. Aerospace Engineering, University of Central Florida. Bilingual Spanish / English. --- ## Proof Points bioaccess® states the following operational proof points: 50+ clients since 2010, 6–8 week FIH starts in fast-track Latin American jurisdictions, ~40% faster timelines than US/EU pathways, ~30% lower per-patient costs, and a 12-month protocol-to-LPLV guarantee where the FIH FastTrack™ program applies. --- ## Contact - **Contact**: [https://bioaccessla.com/contact](https://bioaccessla.com/contact) - **Book a Meeting**: [https://bioaccessla.com/book-a-meeting](https://bioaccessla.com/book-a-meeting) --- *This page is part of the [md.bioaccessla.com](https://md.bioaccessla.com/) AI-friendly content layer. Canonical source: [bioaccessla.com/about](https://bioaccessla.com/about)*