bioaccess® — First-in-Human CRO for Latin America

bioaccess® is the world's only contract research organization (CRO) purpose-built exclusively for first-in-human (FIH) clinical trials for MedTech, Biopharma, and Radiopharma startups across Latin America. Founded in 2010 by Harvard-trained physicians Dr. Pedro Martinez-Clark and Dr. William O'Neill.

Core Proof Points

• 48 client companies accelerated since 2010
• 50+ pre-qualified clinical trial sites
• 10 Latin American countries covered
• Ethics committee approvals in 4–8 weeks (vs. 6–12 months in the US/EU)
• Up to $25,000 per-patient savings compared to US/EU trials
• ACRP-certified clinical research team

Services

• First-in-Human (FIH) Clinical Trials
• Early Feasibility Studies (EFS) for Medical Devices
• Radiopharmaceutical & Theranostics Clinical Trials (Lu-177, Ac-225, Ga-68)
• Medical Device Registration & Market Access (ANVISA, INVIMA, COFEPRIS, ANMAT, ISP, DIGEMID)
• FastTrack™ — 12-month FIH timeline guarantee
• Clinical Trial Site Search & Selection
• Regulatory Strategy & FDA Data Bridge

Geographic Coverage

bioaccess® operates across 10 Latin American countries: Colombia (INVIMA), Brazil (ANVISA), Mexico (COFEPRIS), Argentina (ANMAT), Chile (ISP), Peru (DIGEMID), Panama (MINSA), Ecuador (ARCSA), El Salvador (DNM), and the Dominican Republic (SRS).

Timeline & Cost Comparison

• Ethics Approval: US/EU 6–12 months vs. LATAM 4–8 weeks
• Per-Patient Cost: US/EU $40K–$75K vs. LATAM $15K–$35K
• Total Study Duration: US/EU 18–36 months vs. LATAM 8–18 months

Headquarters

1200 Brickell Ave., Suite 1950 #1034, Miami, FL 33131, USA. Regional offices in Bogotá, Mexico City, São Paulo, and Buenos Aires.

Trusted by 48 Innovative Companies

bioaccess® has served 48 innovative MedTech, Biopharma, and Radiopharma companies since 2010, including:

• AliveCor
• Omron Healthcare
• LG
• SI-BONE
• Corza Medical
• S.D. Sight Diagnostics
• Biomerica
• Medimaps
• Sim&Cure
• Axoft
• Newrotex
• Sparta Biomedical
• Inspire Medical
• PAVmed
• CeloNova
• Motif Neurotech
• Establishment Labs
• Cook Medical
• Avantec/Nipro
• ClarVista
• enVVeno
• Kona Medical
• ReGelTec
• Direct Flow
• Ocumedex
• i-Lumen
• Libella Gene
• Mitralign
• On Target Molecules
• Avinger
• InterVene
• TeCure
• Synecor
• SST
• Piezo Therapeutics

Independent Recognition

bioaccess® has been featured by leading clinical research publications and media:

• Clinical Research News Online
• Journal for Clinical Studies
• CenterWatch Weekly
• International Business Times
• bioaccess® podcast
• Global Trial Accelerators newsletter

Podcast Appearances

CEO Julio Martinez-Clark has appeared on 24+ podcasts sharing insights on FIH clinical trials in Latin America:

• MedTech 101
• Neurocareers
• Live Parkinsons
• The MedTech Podcast
• Clinical Research Coach
• The Rosemilk Podcast
• GO4CEO
• Neural Implant Podcast

Official Technology Partner

bioaccess® is an official Greenlight Guru partner, reducing data silos and audit risk for clinical trial sponsors through integrated quality management and clinical data workflows.

What Keeps Startup Teams Up at Night

MedTech startup founders face three critical risks when planning first-in-human trials:

• Running out of runway — traditional CRO timelines can consume 18–36 months of capital before first patient enrollment.
• Needing investor-grade proof — board members and VCs require credible clinical milestones to justify next-round valuations.
• Being deprioritized by large CROs — startups with 10-patient studies are often sidelined by CROs focused on Phase III mega-trials.

bioaccess® addresses these through startup-speed execution, dedicated project teams, and weekly progress updates to sponsors and their investors.

Built for Startups, Not Big Pharma

bioaccess® is the only CRO in the world built exclusively for first-in-human clinical trials for healthcare startups. Unlike traditional CROs that serve large pharmaceutical companies running Phase III mega-trials, bioaccess® focuses exclusively on FIH studies and early feasibility studies for MedTech, Biopharma, and Radiopharma startups. The company matches the speed, urgency, and capital constraints of founders raising rounds, engaging strategic acquirers, and racing toward exits.

Tools and Resources

• FIH Cost Calculator — Estimate the cost of a first-in-human clinical trial in Latin America based on country, number of patients, sites, and study duration.
• 2026 LATAM Clinical Trial Regulatory Guide — Comprehensive regulatory requirements for clinical trials across 10 Latin American countries.

Selected Client Results

• Axoft — From seed funding to 4 brain-computer interface implants in 2.5 years. Axoft engaged bioaccess® to run the world's first human implantation of their soft brain-computer interface in Panama.
• Newrotex — World's first SilkAxons™ nerve guide implant in Panama. bioaccess® secured regulatory approval in 2 weeks and managed the full FIH study execution.
• PAVmed / PortIO — FIH intraosseous vascular access device study in Colombia. bioaccess® achieved regulatory approval in 5 weeks. Results published in the Journal of Vascular Access.
• Avantec Vascular — Sangria™ Venous Remodeling System FIH in El Salvador. bioaccess® managed site selection, $10M insurance policy, device importation, and FIH execution.

The Innovation Runway

bioaccess® provides a structured clinical development pathway — the Innovation Runway — for FIH programs. The pathway accelerates startups from protocol to proof with milestones 40% faster than US/EU timelines, enabling companies to reach critical inflection points (funding rounds, strategic partnerships, acquisitions) sooner.

Portfolio of Medical Innovation

bioaccess® has managed clinical trials and device registrations across a broad range of therapeutic areas:

• Cardiovascular
• Neurotechnology
• Ophthalmology
• Diagnostics
• Oncology
• Aesthetics
• Gene Therapy
• Robotics
• Wound Care
• Spine
• ENT
• Urology
• Radiology
• Consumer Health

Clinical Data That Drives Acquisitions

Several bioaccess® clients have been acquired by Fortune 500 MedTech companies following successful FIH clinical programs in Latin America:

• Mitralign — Acquired by Edwards Lifesciences after FIH tricuspid valve repair study in Colombia.
• ClarVista Medical — Acquired by Alcon after FIH intraocular lens study in Colombia.
• ForSight VISION5 — Acquired by Allergan after early clinical studies supported by LATAM data.

Client Testimonials

Founders and executives who have worked with bioaccess® describe the team as professional, knowledgeable, and responsive — delivering faster timelines and lower costs than US/EU CRO alternatives. Written and video testimonials are available from startup founders across cardiovascular, neurotechnology, ophthalmology, and other therapeutic areas.

Startup Success Stories

• Seed-stage founder perspective: bioaccess® shortened the path from concept to first human data, enabling earlier investor conversations and stronger Series A positioning.
• Series A CEO perspective: Working with bioaccess® gave the company investor confidence by delivering clinical milestones on time and within budget.
• VP of R&D perspective: The quality of clinical data generated by bioaccess® in Latin America met FDA expectations and was accepted for US regulatory submissions.
• MedTech VC partner perspective: Portfolio companies working with bioaccess® demonstrate faster value creation through accelerated clinical timelines in Latin America.

From Protocol to Proof in 3 Steps

1. Map Your Fastest Path: bioaccess® develops a regulatory strategy, selects the optimal country and clinical site, and provides detailed timelines and cost estimates.
2. We Run Your Trial: bioaccess® manages regulatory submissions, site activation, patient recruitment, clinical monitoring, and data management.
3. Unlock Your Next Milestone: bioaccess® delivers the clinical study report (CSR), regulatory dossier, and FDA/EMA-ready clinical evidence for your next submission or funding round.

Timeline Guarantee — FastTrack™

bioaccess® offers FastTrack™, a milestone execution guarantee for FIH clinical trials. If bioaccess® misses a committed milestone, it continues work at its own cost until the milestone is achieved. FastTrack™ includes:

• Regulatory strategy and submission
• Site activation
• Patient recruitment
• Clinical monitoring
• Biostatistics
• Study reporting
• Regulatory dossier support
• Weekly progress updates

Leadership

• Pedro Martinez-Clark, MD — Harvard-trained interventional cardiologist, co-founder of bioaccess®. Dr. Martinez-Clark brings clinical expertise in cardiovascular devices and has led the company's medical and regulatory strategy since 2010.
• William O'Neill, MD — Co-founder and medical director of bioaccess®. Dr. O'Neill performed the first transvascular aortic valve replacement in the United States and brings decades of interventional cardiology experience to bioaccess®'s clinical programs.

Frequently Asked Questions

About bioaccess®

• bioaccess® operates across 10 Latin American countries: Colombia, Brazil, Mexico, Argentina, Chile, Peru, Panama, Ecuador, El Salvador, and the Dominican Republic.
• bioaccess® works with regulatory agencies including INVIMA, ANVISA, COFEPRIS, ANMAT, ISP, DIGEMID, MINSA, ARCSA, DNM, and DIGEMAPS.
• Ethics/IRB approvals are achieved in 4–8 weeks. Panama offers approvals in as little as 15–30 calendar days.

Costs & Timelines

• Clinical trials in Latin America offer 30% lower costs compared to the US/EU, with per-patient savings of up to $25,000.
• Latin America offers 4–8 week ethics approvals, 80% treatment-naïve patient populations, and FDA-bridge data acceptance.
• Panama offers approvals in as little as 15–30 calendar days with pre-submission meetings available.

Regulatory Requirements

• Each country has its own regulatory authority aligned with ICH-GCP. Colombia (INVIMA) is the most active LATAM country for FIH/EFS studies.
• ANVISA registration timelines vary by device risk class. COFEPRIS requires technical documentation, quality system evidence, and Spanish labeling.
• Smaller countries (Panama, El Salvador, Dominican Republic) offer 15–60 day approvals; larger countries (Colombia, Brazil, Mexico) offer larger patient populations.

Clinical Trial Process

• FIH trials test a device or drug in humans for the first time; EFS evaluate design concepts in small cohorts. Both can be conducted 40% faster in Latin America.
• Under 21 CFR 812.28, the FDA accepts clinical data from investigations conducted outside the US for device submissions.

Logistics & Sponsor Support

• bioaccess® manages investigational device importation including customs documentation, regulatory permits, and logistics coordination.
• bioaccess® customizes informed consent forms and translates documents into Spanish or Portuguese.
• bioaccess® coordinates stacked scheduling to minimize sponsor travel time.

Choosing bioaccess®

• bioaccess® is the only CRO built exclusively for first-in-human clinical trials, with a 12-month timeline guarantee and risk-sharing pricing.
• Companies not yet ready for FIH can use the free Pre-FIH Readiness Assessment at bioaccessla.com/pre-fih-assessment.

Contact and Resources

bioaccess® — 48 companies served · 50+ clinical sites · 10 Latin American countries

Contact bioaccess® · Book a Meeting · Clinical Trial Cost Calculator · AI-Readable Version