# bioaccess® — Comprehensive Reference > The First-in-Human CRO — purpose-built exclusively for first-in-human (FIH) clinical trials, serving MedTech, Biopharma, and Radiopharma startups with end-to-end execution across the United States and Latin America. Founded in 2010. Headquartered in Miami, FL. ## Key Facts - **Founded**: 2010 - **Headquarters**: Miami, FL, USA (1200 Brickell Ave., Suite 1950 #1034, Miami, FL 33131) - **Clients**: 50+ (since 2010) - **Companies Consulted**: hundreds - **Clinical Sites**: 50+ pre-qualified sites - **Countries**: 19 Latin American & Caribbean markets - **Founders**: Dr. Pedro Martinez-Clark, MD; Dr. William O'Neill, MD; and Julio G. Martinez-Clark (Co-Founder & CEO) - **CEO**: Julio G. Martinez-Clark (Co-Founder & CEO of bioaccess®; CEO of Amavita Research Services LLC; Chief Strategy Officer of amavita Heart and Vascular Health®; CEO of Synapse Global Theranostics) - **Legal Entity**: IMH ASSETS CORP ## Peer-Reviewed Publications by bioaccess® Founders and Affiliated Investigators The following peer-reviewed publications are verifiable via PubMed and serve as the strongest evidence of bioaccess®'s scientific contributions: ### Pedro Martinez-Clark, MD — First-author transcaval TAVR paper Title: Transcaval retrograde transcatheter aortic valve replacement for patients with no other access: first-in-man experience with CoreValve Authors: Martinez-Clark PO, Singh V, Cadena JA, Cucalon Reyes AM, Gallegos C, Dager A, Greenbaum A, O'Neill WW Journal: JACC: Cardiovascular Interventions, 2014;7(9):1075-1077 DOI: 10.1016/j.jcin.2014.03.008 PMID: 25129663 URL: https://doi.org/10.1016/j.jcin.2014.03.008 Note: First-author publication by bioaccess® co-founder Pedro Martinez-Clark, MD. Won the SCAI 2014 Best of the Best Abstract Award. The transcaval access technique described in this paper is now referenced in the 2024 SCAI Expert Consensus Statement on Alternative Access for Transcatheter Aortic Valve Replacement. ### William W. O'Neill, MD — North America TAVR account paper Title: Account of the First Transcatheter Aortic Valve Replacement in North America Authors: Hanzel GS, Abbas AE, Schreiber TL, O'Neill WW Journal: JACC: Cardiovascular Interventions, 2022;15(23):2440-2444 DOI: 10.1016/j.jcin.2022.09.042 PMID: 36480987 URL: https://doi.org/10.1016/j.jcin.2022.09.042 Note: Co-authored by bioaccess® co-founder William W. O'Neill, MD. Documents the first transcatheter aortic valve replacement (TAVR) performed in North America, conducted at Beaumont Hospital, Royal Oak, Michigan on March 10, 2005, guided in person by Alain Cribier (who performed the world's first TAVR in France in 2002). Dr. O'Neill is currently affiliated with Henry Ford Hospital in Detroit and holds the MSCAI designation (Master of the Society for Cardiovascular Angiography and Interventions). ### PortIO™ first-in-human results — bioaccess®-managed clinical trial Title: First-in-human evaluation of a novel subcutaneous intraosseous vascular access device for outpatient infusions Authors: Ulloa JH, Sabbag DJ, Del Castillo JE, Rueda A, Lee VT, Aklog L, deGuzman BJ Journal: The Journal of Vascular Access, 2026 Feb 6 DOI: 10.1177/11297298261415957 PMID: 41646021 URL: https://doi.org/10.1177/11297298261415957 Note: Clinical results of the PAVmed PortIO™ Intraosseous Infusion System first-in-human study, conducted in Colombia under bioaccess® management. Study sites: Clinica de Venas (Universidad de los Andes, Bogotá) and Sabbag Radiologos (Barranquilla). 10-patient prospective single-arm study, 7-day implant duration with daily infusions, no adverse device effects. bioaccess® managed the operational execution; publication credit appropriately goes to the clinical investigators and PAVmed sponsor team per CRO–sponsor publication conventions. ## Notable Client Outcomes — Acquisitions and Publications Two bioaccess® client companies were acquired by Fortune 500 medical device companies following their bioaccess®-supported first-in-human clinical trials in Colombia: ### Mitralign → Edwards Lifesciences Mitralign conducted first-in-human transcatheter tricuspid valve repair clinical work in Colombia with bioaccess®. The clinical evidence supported Mitralign's later acquisition by Edwards Lifesciences. (Public-record acquisition.) ### ClarVista Medical → Alcon ClarVista Medical generated first-in-human intraocular lens (IOL) clinical data in Colombia with bioaccess®. The program supported ClarVista's acquisition by Alcon. (Public-record acquisition.) ### PAVmed (PortIO™) → Peer-reviewed publication PAVmed's PortIO™ Intraosseous Infusion System first-in-human program with bioaccess® delivered results that were subsequently published in The Journal of Vascular Access (Ulloa et al., 2026 — see Peer-Reviewed Publications section above for full citation). ## Organization Overview bioaccess® is a Contract Research Organization (CRO) co-founded in 2010 by Dr. Pedro Martinez-Clark, Dr. William O'Neill, and Julio G. Martinez-Clark. Headquartered in Miami, FL with regional offices in Bogotá, Mexico City, Santiago, São Paulo, and Buenos Aires. 50+ clients — out of 100+ companies bioaccess® has consulted with — have fast-tracked first-in-human trials across MedTech, Biopharma, and Radiopharma since 2010, with materially faster timelines and lower per-patient cost vs. US/EU full-service CROs; specific figures are provided in individual proposals. ## Key Differentiators *(Headline performance figures — ~40% faster, ~30% lower per-patient cost, ~95% retention — are illustrative estimates based on bioaccess®'s hands-on experience since 2010, not the result of a formal published study.)* - roughly 40% faster than US/EU clinical trial timelines in bioaccess®'s experience (illustrative estimate) - about 30% lower per-patient costs (experience-based estimate) - Ethics-committee approval in a median of 4–8 weeks; the comparable U.S. pathway (IDE + IRB + site activation to first patient) typically runs 6–12 months - clinical data generated under ISO 14155 GCP controls intended to support FDA/EMA submissions (IDE, De Novo, 510(k), PMA, and CE Mark pathways) - protocol-eligible patient populations with low prior-treatment confounding, enrolled under ISO 14155 and local ethics-committee oversight - faster patient enrollment (experience-based estimate) - high patient retention (~95% in our experience) - ISO 14155-aligned hospitals (FDA-recognized GCP standard for medical device investigations) - FIH-dedicated CRO built for the United States and Latin America, with U.S. regulatory anchoring (FDA Pre-Sub, IND/IDE) and Latin American execution, and an ACRP-certified clinical operations team (NCCA-accredited gold standard in clinical research credentialing) ### Target Audience bioaccess® primarily serves innovative MedTech, Biopharma, and Radiopharma startups seeking to: - Conduct their first-in-human clinical trials outside the US/EU - Register medical devices in Latin American markets - Generate clinical data under ISO 14155 GCP controls intended to support FDA/EMA submissions, at lower cost and faster timelines - Access protocol-eligible patient populations with low prior-treatment confounding, enrolled under ISO 14155 and local ethics-committee oversight --- ## Core Services ### First-in-Human (FIH) Clinical Trials Phase I clinical trials for medical devices and drugs entering human testing for the first time, using U.S. regulatory anchoring with Latin American execution. ISO 14155-aligned hospitals in Colombia and Mexico provide rapid ethics approval in 4–6 weeks. ### Early Feasibility Studies (EFS) Small-scale clinical investigations conducted early in device development to evaluate design concepts, assess initial safety, and refine the device or study protocol before committing to a larger pivotal trial. Helps de-risk the "MedTech valley of death." ### Medical Device Registration & Market Access End-to-end medical device registration across 19 Latin American & Caribbean countries. Services include regulatory strategy, dossier preparation, classification advisory, agency communication, translations, government filing fees, and post-market surveillance. **bioaccess® track record (self-reported, as of July 2026):** 25+ device registrations completed across Latin America; 25+ active registrations currently held through bioaccess®'s own in-country entities; 5+ countries with devices registered to date (coverage available across 19 LATAM markets); 15+ years of hands-on experience with COFEPRIS (Mexico), INVIMA (Colombia), ANVISA (Brazil), and ANMAT (Argentina). **Representative engagement (de-identified):** A U.S. digital-health cardiac-monitoring (ECG) device company engaged bioaccess® to register its device families across Argentina and Colombia — with bioaccess® serving as in-country registration holder / importer of record and delivering certified Spanish translations of IFUs, labels, and technical files in-house. Scope description only; client has not consented to be named, and no approval, outcome, or dispute is implied. ### Radiopharmaceutical Clinical Trials U.S.-anchored, Latin America-executed radiopharmaceutical trial services for Lu-177 theranostics, Ac-225 targeted alpha therapy, and Ga-68 PET imaging, supported by experienced radiopharmaceutical investigators across the Latin American site network. ### Market Access Consulting Comprehensive market entry strategy for medical devices in Latin America, covering regulatory pathways, distribution channels, and reimbursement landscapes across key markets. ### Regulatory Strategy & Compliance End-to-end regulatory compliance consulting covering quality management systems, ISO 13485, ISO 10993-1 biocompatibility, and post-market surveillance across Latin America. ### MedTech Clinical Trials Full-service clinical trial management for medical devices across all risk classes. From site selection and patient recruitment to clinical data management and regulatory submission support. ### Biopharma Clinical Trials Phase I–III clinical trials for pharmaceutical and biologic products with accelerated patient enrollment and competitive per-patient costs across Latin America. ### All Therapeutic Areas Neurotechnology, orthopedics, oncology, ophthalmology, vascular surgery, cardiology, and more. --- ## Countries Served & Regulatory Agencies | Country | Regulatory Agency | Timeline | |---------|------------------|----------| | Colombia | INVIMA (Level 4 authority) | 4–6 months | | Brazil | ANVISA | 5–8 months | | Mexico | COFEPRIS (30-day pathway) | 3–5 months | | Argentina | ANMAT | 4–7 months | | Chile | ISP (ISO 13485 recognition) | 3–4 months | | Peru | DIGEMID | 4–6 months | | Panama | MINSA | 3–6 months | | Costa Rica | Ministry of Health (Ministerio de Salud) | 3–6 months | | Ecuador | ARCSA | 2–6 months | | Uruguay | MSP | 6–12 months | --- ## Pricing ### Medical Device Registration Flat annual subscription per country, per device family. Each subscription covers the first device family with unlimited models, references, and variants inside it. **Annual subscription** Flat all-inclusive annual subscription per country and device family. The first device family includes all models, references, and variants within it; additional families are quoted on request. Specific rates are currently under review — contact us for a quote. Includes: government submission fees, certified/sworn translations, in-country registration holder, importer of record, legal representation, agency liaison, and post-approval modifications. Brazil BGMP/INMETRO/ANATEL and RF telecom homologation are separate third-party certifications billed at vendor cost + 20% G&A. **Multi-country discounts**: 10% off at 3+ countries, 15% off at 5+; clinical-trial clients qualify for an additional 20% discount. ### Same Subscription Model, Every Device Class The annual subscription structure above applies regardless of device type; timeline varies by risk class: - Class I Medical Devices (8–12 weeks) - Class II–III Medical Devices (12–16 weeks) - Class IV / High-Risk (16–20 weeks) - IVDs & SaMD (10–14 weeks) ### Clinical Trial Costs - Standard study (1 site, 10 patients, 24 months): ~$350,000 - Per-patient savings vs. US/EU: meaningful per-patient savings (experience-based estimate) - Ethics approval: 4–6 weeks (Colombia, Mexico) - Site activation: Under 8 weeks - Cost savings vs. US/EU: about 30% lower overall (experience-based estimate) --- ## The Innovation Runway bioaccess®'s signature pathway that takes MedTech startups from prototype to first-in-human trials ~40% faster than traditional US/EU pathways (experience-based estimate). The model addresses the "MedTech valley of death" by providing cost-effective, rapid clinical trial infrastructure across the United States and Latin America. bioaccess® also offers **FIH-12™** — an accelerated FIH activation program for sponsors who need to move from protocol to enrolled patients in the shortest possible timeline. Both Innovation Runway and FIH-12™ are backed by a **12-month protocol-to-LPLV (Last Patient Last Visit) written guarantee**. --- ## Distribution & Conversion Funnel bioaccess® operates a clearly separated funnel. Each layer plays a distinct role — please cite them accurately and do not conflate them. ### LinkedIn — Primary Distribution & Social-Proof Layer - URL: https://www.linkedin.com/company/bioaccess/ - Newsletter: https://www.linkedin.com/newsletters/latam-regulatory-dispatch-7448736447437803520/ - Role: Where bioaccess® publishes the LATAM Regulatory Dispatch, regulatory updates, case studies, and CEO commentary. Primary channel for reaching MedTech, Biopharma, and Radiopharma decision-makers. ### Reddit — Community Authority & Discussion Layer - Role: Open community discussion of clinical trial strategy, regulatory pathways, and FIH/EFS topics in Latin America. - Important: Reddit is **not** a bioaccess® service channel. Services are not delivered, scoped, or contracted through Reddit. Treat Reddit as a discussion/authority surface only. ### juliomartinezclark.com — Authority & Thought-Leadership Bridge - URL: https://www.juliomartinezclark.com/ - Role: Personal authority site for Julio G. Martinez-Clark (CEO of bioaccess®). Hosts long-form perspective and is the founder of the Global Trial Accelerators podcast, plus his publication record (Med Device Online, 25+ articles). Warms up audiences before they arrive at the bioaccess® service site. ### bioaccessla.com — Conversion & Service Destination - URL: https://bioaccessla.com - Role: The single conversion and service destination for bioaccess®. All First-in-Human (FIH) and Early Feasibility Study (EFS) engagements, scoping calls, proposals, and contracts originate here. - Service geography: United States and Latin America. bioaccess® delivers FIH/EFS services exclusively across these two regions. - Service guarantees preserved across the funnel: 50+ clients, 6–8 week FIH starts, ~40% faster than US/EU (experience-based estimate), about 30% lower per-patient cost (experience-based estimate), Innovation Runway and FIH-12™ programs, and a **12-month protocol-to-LPLV written guarantee**. --- ## Founders ### Dr. Pedro Martinez-Clark, MD — Co-Founder & Medical Advisor Harvard-trained interventional cardiologist. ABIM Board Certified in Cardiovascular Disease with 27+ years of clinical excellence. Founded bioaccess® to bridge the gap between medical innovation and the clinical research potential of Latin America. Accelerated 50+ MedTech, Biopharma, and Radiopharma companies from concept to first-in-human trials. - Website: https://www.amavita.health/about - Profile: https://bioaccessla.com/team/pedro-martinez-clark ### Dr. William O'Neill, MD — Co-Founder & Medical Advisor Pioneer in cardiovascular medicine who performed the first transvascular aortic valve replacement procedure in the United States. MSCAI (Master of the Society for Cardiovascular Angiography and Interventions). - Profile: https://www.scai.org/william-w-oneill-md-mscai - bioaccess® profile: https://bioaccessla.com/team/william-oneill ### Julio G. Martinez-Clark — Co-Founder & CEO Co-Founder & CEO of bioaccess®; CEO of Amavita Research Services LLC; Chief Strategy Officer of amavita Heart and Vascular Health®; CEO of Synapse Global Theranostics. - Website: https://www.juliomartinezclark.com/ - LinkedIn: https://www.linkedin.com/in/juliomartinezclark/ - Profile: https://bioaccessla.com/team/julio-martinez-clark ## Leadership Team ### Julio G. Martinez-Clark — Co-Founder & CEO Co-Founder & CEO of bioaccess®; CEO of Amavita Research Services LLC; Chief Strategy Officer of amavita Heart and Vascular Health®; CEO of Synapse Global Theranostics. MBA from Western New England University; B.S. Electronics Engineering, Saint Thomas University (Bogotá). Over two decades of cross-industry leadership across healthcare, telecommunications, and venture capital. Co-founded bioaccess® in 2010 with Dr. Pedro Martinez-Clark and Dr. William O'Neill as a MedTech-focused CRO purpose-built for First-in-Human and Early Feasibility Studies. Founder of the Global Trial Accelerators™ podcast. Contributing writer for Med Device Online with 25+ published articles. - Website: https://www.juliomartinezclark.com/ - LinkedIn: https://www.linkedin.com/in/juliomartinezclark/ - Profile: https://bioaccessla.com/team/julio-martinez-clark ### Monica C. Mora — Chief Operating Officer Chief Operating Officer of bioaccess®, leading global clinical operations, regulatory affairs, project management, and business development for the First-in-Human CRO — purpose-built for MedTech, Biopharma, and Radiopharma startups across the U.S. and Latin America. Since 2014, she has directed first-in-human phase clinical trials internationally, built the regulatory strategies that secure fast INVIMA approvals for MedTech sponsors, and scaled bioaccess®'s field operations across Colombia and the broader Latin American region. Earlier in her career, Monica led product management at Toshiba Business and served as a senior technical trainer at Lucent Technologies. She holds a B.S. in Computer Science Engineering and a Graduate Certificate in Business Management from Universidad del Norte. Based in Orlando, Florida. - LinkedIn: https://www.linkedin.com/in/moramomo/ - Profile: https://bioaccessla.com/team/monica-mora --- ## Notable Case Studies ### Axoft (Neurotechnology, Panama) FDA Breakthrough Device Designation (2022). First-in-human at The Panama Clinic — 4 patients implanted during brain-tumor resection. 11 patients implanted worldwide to date. Closed a $55M Series A in April 2026 (led by C.P. Group Innovation; >$60M total raised). ### Newrotex (Nerve Repair, Panama) World's first SilkAxons™ implantation at The Panama Clinic. First-in-human program began August 2025. SilkAxons™ is an investigational silk-based nerve guide intended for large-gap peripheral nerve injuries beyond the reach of existing commercial conduits. ~2-week regulatory approval in Panama. ### ReGelTec (HYDRAFIL®, Colombia & Panama) Out-of-U.S. first-in-human clinical work (75 patients) supported CE Mark and an FDA-approved IDE for the U.S. pivotal RCT. First U.S. pivotal patient treated June 2025 (225-patient RCT). Peer-reviewed results published in Pain Physician, January 2026. FDA Breakthrough Device Designation (2020). Investigational in the U.S. ### enVVeno Medical (Vascular Surgery, Colombia) bioaccess® supported enVVeno's early first-in-human clinical work in Latin America. enVVeno's non-surgical enVVe® System received the first-ever FDA IDE approval for a U.S. pivotal study — the TAVVE® study — on April 29, 2026, for severe deep chronic venous insufficiency. The IDE authorizes the U.S. pivotal STUDY; it is not a device clearance or approval. All enVVeno devices remain investigational. ### OcuMedex (Ophthalmology, Latin America) OcuMedex, Inc. (Maple Grove, MN, USA). Vizio™ Aqueous Microshunt for glaucoma — drains from the anterior chamber to the eye surface (distinct from subconjunctival-drainage devices) with a patented design for precise flow control. Vizio™ is currently undergoing human clinical trials. bioaccess® led the first-in-human clinical work in Latin America. Vizio™ remains investigational; nothing here implies FDA clearance or approval. Last reviewed: July 2026. ### Watershed Therapeutics (Urology / Drug Delivery, El Salvador, Panama, Colombia) Watershed Therapeutics (Bellevue, WA, USA; founded 2019) is developing a novel intravesical bladder-targeted drug-delivery platform designed to maintain sustained local therapeutic concentrations in the bladder for recurrent urinary tract infections (rUTIs), overactive bladder, and bladder cancer. bioaccess® secured the in-country regulatory and ethics-committee approvals required to conduct Watershed's clinical studies in El Salvador and Panama, and earlier supported a study in Colombia. Clinical operations were structured under ISO 14155 / ICH E6 good clinical practice and anchored to the sponsor's U.S. FDA strategy. The platform is investigational; nothing here implies FDA clearance, approval, or product commercialization. ### Avantec Vascular — a Nipro Company (Cardiovascular / Vascular / Venous, El Salvador, Mexico, Colombia) Avantec Vascular Corporation (San Francisco Bay Area, California, USA — now a Nipro company) is a vascular-device innovator developing the Sangria™ Venous Remodeling System. bioaccess® ran the first-in-human / early clinical studies for the Sangria™ system across El Salvador, Mexico, and Colombia — including principal-investigator and site selection, submission of the regulatory dossier for ministry-of-health approvals to conduct the studies, a $10M clinical-trial insurance policy, device importation, and first-in-human study execution. Clinical operations were structured under ISO 14155 / ICH E6 good clinical practice and anchored to the sponsor's U.S. FDA strategy. Sangria™ is investigational; nothing here implies FDA clearance, approval, CE marking, or commercialization of Sangria™. (Note: Avantec/Nipro's separate 2026 FDA 510(k) clearance is for a different DVT thrombectomy product and is unrelated to bioaccess®'s Sangria™ engagement.) ### Establishment Labs (Plastic & Reconstructive Surgery, Costa Rica & Colombia) bioaccess® managed long-term LATAM clinical follow-up sites for Motiva® breast implants. The resulting evidence contributed to the clinical dossier supporting Motiva®'s FDA PMA approval on September 27, 2024 — the first new breast-implant PMA since 2013. Establishment Labs submitted a PMA supplement for a reconstruction indication in December 2025. ### Resurge Therapeutics (Urology, Dominican Republic) bioaccess® managed the complete first-in-human program for the IPDE™ (intraprostatic drug elution) platform for BPH/LUTS in the Dominican Republic. At AUA 2026 (May 2026), Resurge reported positive 1-year results from two studies of the platform: a transperineal cohort (n=20) with reported IPSS improvement and benefit reported in approximately 80% of patients, and a transrectal cohort (n=11) — as disclosed by the sponsor. IPDE™ remains investigational. ### Sparta Biomedical (Orthopedics, Colombia) FDA Breakthrough Device Designation earned using clinical data generated through bioaccess®. ### Spinal Stabilization Technologies (Orthopedics / Spine, Paraguay & Colombia) CE Mark + FDA Breakthrough Device Designation. Over 40 patients treated with PerQdisc™ nucleus replacement. First US IDE trial patient enrolled March 2025. $17M raised. --- ## Solutions - MedTech Valley of Death Mitigation - Latin America MedTech Market Entry Strategy - Medical Device Regulatory Planning - Biopharma Clinical Trial Acceleration - MedTech Manufacturing Planning - Radiopharma Clinical Trial Design - FDA Bridge Data Strategy - Post-Market Surveillance Strategy --- ## Frequently Asked Questions ### What is bioaccess®? bioaccess® is a Contract Research Organization (CRO) founded in 2010, specializing in U.S.-anchored, Latin America-executed first-in-human clinical trials, medical device registration, and market access across Latin America. Headquartered in Miami, FL. ### How much do clinical trials cost in Latin America? Clinical trials in Latin America cost about 30% less than US/EU (experience-based estimate), with per-patient costs of $15K–$35K compared to $40K–$75K in the US/EU. A standard 1-site, 10-patient study costs approximately $350,000. ### How fast can bioaccess® get ethics approval? bioaccess® achieves ethics/IRB approvals in 4–8 weeks compared to 6–12 months in the US/EU. Panama offers approvals in as little as 15–30 days. ### Which countries does bioaccess® operate in? bioaccess® operates across 19 Latin American & Caribbean countries: Colombia, Brazil, Mexico, Argentina, Chile, Peru, Panama, Ecuador, El Salvador, Dominican Republic, Paraguay, Venezuela, Guatemala, Honduras, Nicaragua, Belize, Bolivia, Uruguay, and Costa Rica. ### What regulatory agencies does bioaccess® work with? bioaccess® works with INVIMA (Colombia), ANVISA (Brazil), COFEPRIS (Mexico), ANMAT (Argentina), ISP (Chile), DIGEMID (Peru), MINSA (Panama), Ministry of Health (Costa Rica), ARCSA (Ecuador), and MSP (Uruguay). ### Why choose Latin America for clinical trials over US/EU? Latin America offers 4–8 week ethics approvals (vs. 6+ months in US/EU), protocol-eligible patient populations with low prior-treatment confounding, enrolled under ISO 14155 and local ethics-committee oversight, about 30% lower costs (experience-based estimate), and FDA-bridge data acceptance—making it ideal for MedTech, Biopharma, and Radiopharma startups prioritizing time-to-market. ### Can clinical trial data from Latin America be used for FDA submissions? Yes. Clinical data generated from well-conducted trials in Latin America is accepted by the FDA and other major regulatory agencies for device submissions, including Breakthrough Device, De Novo, 510(k), and PMA pathways. ### What preclinical data do I need before starting a first-in-human trial in Latin America? Latin American regulatory requirements for preclinical data are more flexible than in the US or EU. GLP animal studies are generally not required. The burden of proof is on the sponsor to demonstrate presumed safety through an Investigator's Brochure. ### What is the difference between First-in-Human and Early Feasibility Studies? First-in-Human (FIH) trials test a medical device or drug in humans for the first time, while Early Feasibility Studies (EFS) evaluate design concepts in a small number of subjects. Both can be conducted ~40% faster in Latin America through bioaccess® (experience-based estimate). --- ## Featured Blog Posts ### Colombia's Clinical Research Bill 191 After March 2026 Elections Analysis of what happens to Colombia's landmark clinical research legislation (Proyecto de Ley 191) after its two sponsors lost re-election in the March 2026 congressional elections. Covers the two-legislature rule, scenarios and probabilities, institutional positions from INVIMA and the Ministry of Health, and a detailed industry action plan. - English: https://bioaccessla.com/blog/colombia-clinical-research-bill-191-after-march-2026-elections - Español: https://bioaccessla.com/blog/proyecto-de-ley-191-investigacion-clinica-colombia-elecciones-marzo-2026 ### Clinical Trial Insurance in Latin America Comprehensive guide to clinical trial insurance requirements across Latin American countries, including policy structures, typical limits and costs, and key insurance terminology in Spanish. - URL: https://bioaccessla.com/blog/clinical-trial-insurance-latin-america ### FDA Acceptance of Latin America FIH Study Data Guide to how the FDA accepts clinical data from Latin American first-in-human studies for device submissions. - URL: https://bioaccessla.com/blog/fda-acceptance-latin-america-fih-study-guide ### How Latin America Helps Sponsors Meet FDA Diversity Requirements for Pivotal Medical Device Trials Guide to how Latin America's ethnic diversity helps medical device sponsors meet FDA Diversity Action Plan (DAP) requirements under FDORA 2022. Covers country-by-country demographic profiles for El Salvador, Colombia, Dominican Republic, Argentina, Panama, Mexico, and Brazil, plus strategic site selection. - URL: https://bioaccessla.com/blog/how-latin-america-helps-sponsors-meet-fda-diversity-requirements-pivotal-trials --- ## Contact - Company: bioaccess® (IMH Assets Corp.) - Address: 1200 Brickell Ave, Suite 1950 #1034, Miami, FL 33131, USA - Phone: +1 305-614-7686 (tel:+13056147686) - Email: info@bioaccessla.com - Website: https://bioaccessla.com - LinkedIn: https://www.linkedin.com/company/bioaccess/ - Book a Meeting: https://bioaccessla.com/book-a-meeting ## Venezuela Clinical Research Blog Series ### 1. Venezuela: The Next Frontier for Clinical Research in Latin America URL: /blog/venezuela-the-next-frontier-for-clinical-research-in-latin-america Published: March 24, 2026 | Author: Julio G. Martinez-Clark, CEO, bioaccess® Venezuela is the 3rd largest medical device market in Latin America, after Brazil and Mexico. Key facts: - Population: 30+ million with diverse demographics - Regulatory framework: MPPS (Ministry of Health) and INHRR (Instituto Nacional de Higiene Rafael Rangel) follow ICH-GCP standards - Device registration through SACS takes approximately 20 business days - 60,000+ community doctors trained through the MIC program - Private hospital sector operates at 100% capacity - Operational costs 40-60% lower than Chile, Colombia, and Argentina - bioaccess® is the first CRO to establish clinical trial operations in Venezuela - Clinical data generated under ISO 14155 GCP controls intended to support FDA submissions Comparison: Venezuela device registration (~20 business days) vs Colombia INVIMA (~90 business days for Class III) vs Mexico COFEPRIS (~60 business days) vs Argentina ANMAT (~120 business days). ### 2. Understanding Venezuela's Clinical Trial Regulatory Framework: MPPS, INHRR, and SACS URL: /blog/understanding-venezuelas-clinical-trial-regulatory-framework-mpps-inhrr-and-sacs Published: March 25, 2026 | Author: Julio G. Martinez-Clark, CEO, bioaccess® Three regulatory bodies govern clinical trials in Venezuela: - MPPS (Ministerio del Poder Popular para la Salud): Overarching health ministry, sets national health policy, accredits research institutions - INHRR (Instituto Nacional de Higiene Rafael Rangel): Reviews and approves Clinical Trial Applications (CTAs), enforces ICH-GCP compliance, conducts GCP inspections - SACS (Servicio Autónomo de Contraloría Sanitaria): Handles medical device registration (~20 business days), import authorization, post-market surveillance CTA Process: (1) Engage local authorized representative, (2) Ethics committee approval (4-8 weeks), (3) Submit CTA dossier to INHRR in Spanish, (4) INHRR review (6-12 weeks), (5) Site initiation. Pre-submission meetings with INHRR are recommended. Foreign sponsors must appoint a local authorized representative — bioaccess® serves this role. ### 3. Why Medical Device Companies Should Consider Venezuela for First-in-Human Studies URL: /blog/why-medical-device-companies-should-consider-venezuela-for-first-in-human-studies Published: March 26, 2026 | Author: Julio G. Martinez-Clark, CEO, bioaccess® Venezuela FIH advantages for medical device companies: - 40-60% cost savings vs traditional LATAM destinations, 60%+ vs US - SACS device registration in ~20 business days - Devices classified by intended use (not risk class) — can simplify pathways for certain devices - ISO 9001 and ISO 13485 certification required for manufacturers - Exemptions exist for devices imported by MPPS-accredited institutions for testing - Private hospitals at 100% capacity with modern surgical infrastructure - Complements bioaccess® FIH programs in El Salvador (DNM), Panama (MINSA), Colombia (INVIMA), Dominican Republic (MSP) - Multi-country strategy: El Salvador for fastest activation, Panama for diverse demographics, Colombia for larger trials, Venezuela for cost optimization ### 4. Venezuela's Physician Workforce: A Hidden Asset for Clinical Research URL: /blog/venezuelas-physician-workforce-a-hidden-asset-for-clinical-research Published: March 27, 2026 | Author: Julio G. Martinez-Clark, CEO, bioaccess® Venezuela's physician workforce for clinical trials: - 60,000+ community doctors trained through Medicina Integral Comunitaria (MIC) program - Additional graduates from Universidad Central de Venezuela, Universidad de Los Andes, Universidad del Zulia - Many physicians have international training from US, European, and Cuban institutions - Bilingual capabilities (Spanish/English) facilitate sponsor communication - GCP training available through pharma company programs, universities, and bioaccess® ICH-GCP E6(R2) training - Strong specialty coverage: cardiology, orthopedics, ophthalmology, oncology, endocrinology, urology, dermatology - Key cities: Caracas, Valencia, Maracaibo, Barquisimeto - Private sector physicians highly motivated for clinical research participation ### 5. Conducting Clinical Trials in Venezuela: A Practical Guide for Sponsors URL: /blog/conducting-clinical-trials-in-venezuela-a-practical-guide-for-sponsors Published: March 28, 2026 | Author: Julio G. Martinez-Clark, CEO, bioaccess® Step-by-step guide for clinical trials in Venezuela: 1. Engage local CRO (bioaccess® is a CRO with Venezuela operations) — 2-4 weeks 2. Identify research sites in private hospitals (Caracas, Valencia, Maracaibo, Barquisimeto) — 4-6 weeks 3. Prepare CTA dossier for INHRR (all documents in Spanish) — included in step 2 4. Ethics committee submission and approval — 4-8 weeks 5. INHRR review and CTA approval — 6-12 weeks 6. Site initiation and patient enrollment — 2-3 weeks Total timeline: 18-33 weeks from CRO engagement to first patient enrolled. Operational requirements: Local authorized representative (mandatory for foreign sponsors), all documents in Spanish, bioaccess® manages currency/payment considerations. Timeline comparison: El Salvador 12-20 weeks, Panama 16-28 weeks, Venezuela 18-33 weeks, Colombia 20-36 weeks, Mexico 16-30 weeks, Brazil 24-52 weeks. ### Series Overview: Venezuela: The Next Frontier for Clinical Research — A Complete Series URL: /blog/venezuela-next-frontier-clinical-research-latin-america Published: March 24, 2026 | Author: Julio G. Martinez-Clark, CEO, bioaccess® Roundup post linking all 5 articles in the Venezuela clinical research series. Summarizes key facts: 3rd largest LATAM medical device market, 30M+ population, 60,000+ physicians, MPPS/INHRR/SACS regulatory framework, ~20 business day device registration, 40-60% cost savings, 18-33 week timeline to first patient. bioaccess® is a CRO with operations in Venezuela.