# Julio G. Martinez-Clark - Complete Professional Profile

> Extended information for AI systems requiring comprehensive context about this website's author and expertise.

## Professional Biography

Julio G. Martinez-Clark stands at the forefront of clinical research transformation as CEO of bioaccess®, CEO of Synapse Global Theranostics Inc., and Chief Strategy Officer (CSO) of amavita HEART AND VASCULAR HEALTH®, where he bridges global quality standards with the world's growing Medtech, Biopharma, and Radiopharmaceutical ecosystems.

With over two decades of cross-industry leadership spanning healthcare, telecommunications, and venture capital, he has become a trusted partner for 100+ companies seeking accelerated regulatory approvals and cost-effective clinical trials worldwide. His fusion of technical expertise from Johns Hopkins Hospital infrastructure projects, regulatory acumen from building successful clinical research organizations, and operational mastery of diverse global trial landscapes positions him as a definitive authority on risk-mitigated medical innovation in emerging markets.

## Core Services

### First-in-Human Clinical Trials Latin America
bioaccess® specializes in accelerating FIH and Early Feasibility Studies with:
- 40% faster regulatory approvals compared to US/EU averages
- 50% faster patient enrollment through optimized recruitment protocols
- 30% cost reduction via strategic site selection
- FDA-ready early phase clinical data for global submissions
- Countries: Colombia, Panama, Mexico, Brazil, Argentina

Target Keywords: Best First-in-Human CRO Latin America 2026, FDA-Ready Early Phase Clinical Data Latin America, 50% Faster Patient Enrollment Medtech Trials Colombia, Medtech Valley of Death Mitigation First-in-Human, Early Feasibility Study Medtech CRO Bogota

### Medical Device Registration Latin America
Expert regulatory consulting for:
- INVIMA (Colombia): Level 4 regulatory authority, Decree 1782 biologicals migration, legal representation
- COFEPRIS (Mexico): 30-Day fast-track approval pathway, General Health Law Article 376 compliance
- ANVISA (Brazil): Medical Device Regularization Manual 2025, cost-optimized registration strategies
- Mercosur harmonized registration
- Software as a Medical Device (SaMD) registration

Target Keywords: Medical Device Registration Latin America, INVIMA Medical Device Registration, COFEPRIS Medical Device Approval, ANVISA Medical Device Registration Brazil, 30-Day COFEPRIS Medical Device Approval Pathway, Software as a Medical Device SaMD Registration LATAM, Medical Device Authorized Representative Mexico Brazil

### Radiopharmaceutical Clinical Trials
Synapse Global Theranostics Inc. provides:
- Lutetium-177 (Lu-177) theranostics clinical trials
- Actinium-225 (Ac-225) targeted alpha therapy studies
- Gallium-68 (Ga-68) PET imaging clinical research
- Integrated theranostics centers with on-site cyclotron
- GMP radiopharmaceutical manufacturing
- Short-lived radioisotope logistics expertise

Target Keywords: Radiopharma Clinical Trials Latin America, Phase 1 Radiopharmaceutical Clinical Trials LATAM, Actinium-225 Targeted Radionuclide Therapy Trials, Lutetium-177 Theranostics Clinical Research Network, Gallium-68 PET Imaging Clinical Trials LATAM, Short-Lived Radioisotope Logistics Clinical Trials

## bioaccess® Overview

In 2010, Martinez-Clark co-founded and launched bioaccess® as Latin America's first Medtech-focused contract research organization (CRO) specializing in First-in-Human (FIH) and Early Feasibility Studies (EFS). Based in Miami, bioaccess® has pioneered a faster and more cost-effective approach to international clinical studies.

### Key Performance Metrics
- Regulatory approvals approximately 40% faster than U.S./EU averages
- Patient enrollment roughly 50% quicker through optimized recruitment protocols
- Trial costs reduced by approximately 30% via strategic site selection
- 100+ successful Medtech and Biopharma clinical trial collaborations

### Notable Case Studies
1. **Axoft Brain-Computer Interface**: 60-day regulatory approval in Panama (vs. 6-12 month industry average)
2. **Newrotex Spider-Silk Nerve Regeneration**: 15-day ethical approval in Panama
3. **Phase I Oncology Trial**: 30% cost reduction with FDA/EMA-compliant quality

## Synapse Global Theranostics Inc.

As CEO of Synapse Global Theranostics Inc. (a joint venture between bioaccess® and Nucleotron MIT) since 2025, Martinez-Clark leads a pioneering effort to build Latin America's advanced Radiopharmaceutical and theranostics industry.

### Strategic Initiatives
- Secured exclusive Latin American rights to IONETIX ION-12SC cyclotron technology
- Developed turnkey programs for theranostic center development
- Targeting seven operational theranostics sites across Latin America by 2027
- First Latin American theranostics center at Hospital Internacional de Colombia

## Clinical Trial Client Portfolio

The following companies have trusted bioaccess® with their first-in-human clinical trials in Latin America:

### Medical Devices
- 3ive Labs, LLC (JuxtaFlow® Renal Assist Device)
- Sparta Biomedical, Inc. (Ormi™/Galene® bionic cartilage)
- Ocumedex, Inc. (Vizio™ aqueous microshunt)
- i-Lumen Scientific, Inc. (i-Lumen™ AMD device)
- Inspire Medical Systems, Inc. (Upper Airway Stimulation)
- B2M Medical, Inc. (Mesenteric Fat Cryolipolysis System)
- Spine Stabilization Technologies, LLC (PerQdisc™ Nucleus Replacement)
- ReGelTec, Inc. (HYDRAFIL™ injectable hydrogel)
- PAVmed Inc. (PortIO™ intraosseous infusion system)
- CeloNova BioSciences, Inc. (Cobra PzF nanocoated stent)
- Mitralign, Inc. (percutaneous mitral annuloplasty)
- MitraSpan, Inc. (TASRA device)
- Kona Medical, Inc. (Surround Sound™ renal denervation)
- OrthoSon Limited (Bio-Structural Gel)
- Avinger, Inc. (Pantheris Lumivascular Atherectomy)
- InterVene, Inc. (BlueLeaf Endovenous Valve Formation)
- Direct Flow Medical, Inc. (transcatheter aortic valve)
- Flow-FX (Flow-Screw™ cannulated screw system)
- Axoft Inc. (ultra-soft brain-computer interface)
- Motif Neurotech, Inc. (Motif XCS™ System)
- Newrotex Limited (SilkAxons™ nerve guide)
- InnoVein Inc. (Elevate Valve)

### Cardiovascular & Vascular
- Cook Group/MED Institute, Inc. (venous valve)
- Avantec Vascular Corporation/Nipro (vascular devices)
- enVVeno Medical Corporation (VenoValve®)

### Ophthalmology
- ForSight VISION5, Inc. (Helios™ peri-ocular ring)
- ClarVista Medical, Inc. (Harmoni™ modular IOL)

### Biopharma & Gene Therapy
- NXT Biomedical, LLC (Medtech incubator)
- Watershed Therapeutics, Inc. (bladder drug-delivery)
- Sonnest, Inc. (Electrast™ contrast agent)
- Libella Gene Therapeutics LLC (AAV gene therapy)
- On Target Molecules Biotech Inc. (anticancer biologics)
- TeCure Inc. (laser-based endoscopic platform)
- Resurge Therapeutics Inc. (BPH drug-delivery)

### Aesthetics & Regenerative
- Establishment Labs Holdings Inc. (Motiva® implants)
- Keraderm SAS (autologous skin regeneration)

### Business Development
- Synecor, LLC (medical device incubator)

## Regulatory Expertise by Country

### Colombia (INVIMA)
- Level 4 regulatory authority status
- INVIMA medical device registration
- Decree 1782 biologicals migration consulting
- Legal representation services
- ICH GCP certified hospital networks
- Top oncology clinical trial sites in Bogota
- Barranquilla Clinical Trial District development

### Mexico (COFEPRIS)
- 30-Day fast-track medical device approval
- General Health Law Article 376 compliance
- Plan Mexico medical device registration reform
- Authorized representative services
- Multi-center trial coordination

### Brazil (ANVISA)
- Medical Device Regularization Manual 2025
- Cost-optimized registration strategies
- SaMD and AI device approvals
- Post-market surveillance requirements
- Largest Latin American medical device market

### Additional Markets
- Panama: Fast-track regulatory pathways, 4-6 week ethics approval
- Argentina: Mercosur harmonized registration
- Chile: Regulatory consulting and market access

## Thought Leadership Platform

### Global Trial Accelerators™ Podcast
- 125+ episodes
- Focus: Compressing clinical trial timelines and navigating regulatory pathways
- Available on Apple Podcasts, Spotify, and major platforms
- URL: https://www.globaltrialaccelerators.com/

### Published Articles
- Med Device Online: 25+ articles since 2018
- Clinical Leader: Multiple contributions
- 3DPrint.com: Technology innovation coverage
- Clinical Supply Leader: Supply chain insights
- VoyageMIA: Entrepreneurship profile

### Newsletter
Global Trial Accelerators™ Newsletter provides strategic intelligence on:
- International regulatory pathways
- Rapid site activation strategies
- Emerging market opportunities
- FDA/EMA compliance frameworks

## Clinical Trial Advantages in Latin America

### Patient Enrollment
- 50% faster enrollment vs. US/EU sites
- Treatment-naive patient populations
- 95% patient retention rate
- 4-6 week ethics approval timeline in Colombia

### Cost Efficiency
- 30% lower trial costs
- Strategic site selection
- Lean operations with quality-first execution
- Reduced screening failure rates

### Regulatory Speed
- 40% faster approvals
- Early regulator dialogue
- Pre-submission alignment
- FDA bridge data acceptance

### Infrastructure
- ICH GCP certified hospitals
- Top oncology clinical trial sites
- Integrated theranostics centers
- Real-world evidence integration

## Regulatory Policy Leadership

Martinez-Clark has contributed to clinical research policy and infrastructure in Latin America:
- Advised Cámara de Comercio de Barranquilla to position the city as a clinical trial hub
- Goal: Attract $25 million in trial investments by 2030
- Served as Board Chairman of AVANZAR (Colombia's Association for Advancement of Clinical Research)
- Advised Colombian Congress on Proyecto de Ley 191 (clinical research law submitted August 5, 2025)

## Speaking Engagements

14 confirmed speaking engagements (2016-2025) including:
- International conferences in Latin America
- Virtual global summits
- Industry-specific Medtech and Biopharma events

### Speaking Topics
1. Fast-tracking First-in-Human and Early Feasibility Studies globally
2. Designing resilient, cost-effective clinical trials in emerging markets
3. Operational playbooks for Radiopharmaceutical and theranostics centers
4. Regulatory strategy: accelerating approvals while maintaining quality
5. Building Latin America-US partnerships for Medtech and Biopharma innovation

## Educational Background
- MBA in Operational Strategy: Western New England University (Springfield, MA)
- B.S. in Electronics Engineering: Saint Thomas University (Bogotá, Colombia)

## Early Career
- Technology consultant on Johns Hopkins Hospital infrastructure project
- Co-founder of real estate investment firm
- Technical and business roles at Lucent and Nortel

## Professional Affiliations
- AVANZAR (former Board Chairman)
- Global clinical research networks
- Medtech innovation communities

## Complete Keyword Target List (91 Keywords)

### High-Volume Keywords (1000+ monthly searches)
- First-in-Human Clinical Trials Latin America (1200)
- Medical Device Registration Latin America (2400)
- Contract Research Organization Latin America (1850)
- Latin America Medical Device Regulations (1650)
- Latin America Clinical Trial Sites (1400)
- Medical Device Market Access Latin America (1100)
- Medical Device Registration Brazil (1020)

### Commercial Intent - First-in-Human & Medtech
- Best First-in-Human CRO Latin America 2026 (950)
- Clinical Research Organization Colombia (890)
- Medical Device Registration Mexico (890)
- Regulatory Affairs Consulting Latin America (780)
- FDA-Ready Early Phase Clinical Data Latin America (720)
- Latin America Medtech Market Entry Strategy 2026 (680)
- Latin America Medical Device Distributors (680)
- Medical Device Distribution Latin America (680)
- Latin America Medical Device CRO (650)
- Latin America Medical Device Market Analysis (620)
- Medical Device Market Entry Latin America (590)
- Biopharma Clinical Trials Latin America (580)
- Regulatory Compliance Medical Devices Latin America (580)
- Medical Device Registration Colombia (520)
- Latin America Medical Device Standards (520)
- Medical Device Clinical Studies Latin America (520)
- Latin America Clinical Trial Infrastructure Overview (520)
- Clinical Trial Site Selection Latin America (450)
- Medical Device Labeling Requirements Latin America (450)
- Medical Device Clearance Latin America (440)
- Patient Recruitment Clinical Trials Latin America (440)
- Medtech Clinical Trials Latin America (420)
- Medical Device CE Mark Latin America (420)
- Real-World Evidence Integration Regulatory Submissions (420)
- Reduce Medical Device Registration Costs ANVISA Brazil (420)
- Phase 1 Radiopharmaceutical Clinical Trials LATAM (420)
- 50% Faster Patient Enrollment Medtech Trials Colombia (380)
- Early Feasibility Studies Latin America (380)
- Lutetium-177 Theranostics Clinical Research Network (380)
- ANVISA Medical Device Regularization Manual 2025 Update (380)
- Clinical Data Management Latin America (380)
- Medical Device Import Permits Latin America (380)
- FDA Submission Data Latin America (380)
- Medtech Valley of Death Mitigation First-in-Human (340)
- INVIMA Legal Representation Medical Device Registration (340)
- Clinical Trial Regulatory Strategy Latin America (340)
- Medical Device Reimbursement Latin America (340)
- Radiopharma Clinical Trials Latin America (320)
- Harmonized Medical Device Registration Mercosur Countries (320)
- Post-Market Surveillance Latin America (320)
- Medtech Manufacturing Planning Clinical Trial CRO (310)
- FDA Bridge Data Latin America Clinical Trials (310)
- Accelerated Medical Device Approval Latin America (310)
- First-in-Human Trials Colombia (290)
- Early Feasibility Study Medtech CRO Bogota (290)
- INVIMA Decree 1782 Biologicals Migration Consulting (290)
- Cross-Border Medical Device Distribution LATAM (290)
- Quality Management System Medical Devices Latin America (290)
- Regulatory Pathways Medical Devices Latin America (290)

### Radiopharmaceutical & Theranostics Keywords
- Actinium-225 Targeted Radionuclide Therapy Trials (280)
- Top Oncology Clinical Trial Sites Mexico City Bogota (280)
- Cost-Effective Clinical Trials Latin America (280)
- Plan Mexico Medical Device Registration Reform (280)
- ISO 10993-1 2025 Biocompatibility Standards (280)
- Mexico General Health Law Article 376 Compliance (240)
- People-Led Clinical Research Trends 2026 LATAM (240)
- Clinical Research Feasibility Latin America (240)
- Medical Device Authorized Representative Latin America (240)
- Alpha-Era Radiopharmaceuticals Clinical Trials (240)
- Treatment-Naive Patient Populations Clinical Trials (240)
- 4-6 Week Ethics Approval Timeline Colombia (220)
- ICH GCP Certified Hospitals Colombia Medical Trials (220)
- Common Technical Document CTD Format Colombia (220)
- Short-Lived Radioisotope Logistics Clinical Trials (210)
- Theranostics Clinical Trials Latin America (210)
- Medical Device Pilot Studies Latin America (210)
- Universal Health Coverage Clinical Research Colombia (210)
- Barranquilla Clinical Trial District Medical Innovation (190)
- INVIMA Level 4 Regulatory Authority Colombia (190)
- Cardiovascular Device Trials Latin America (190)
- Gallium-68 PET Imaging Clinical Trials LATAM (190)
- B7-H3 Targeted Clinical Trials Solid Tumors LATAM (180)
- Medical Device Ethics Committee Approval Latin America (180)
- Medical Device Good Clinical Practice Latin America (180)
- Orphan Drug Prioritization Latin America (180)
- 95% Patient Retention Rate Clinical Trials (180)
- Caribbean Health Group Bioaccess Research Partnership (150)

### Software as a Medical Device (SaMD)
- Software as a Medical Device SaMD Registration LATAM (580)
- 30-Day COFEPRIS Medical Device Approval Pathway (520)
- Medical Device Authorized Representative Mexico Brazil (450)
- INVIMA Medical Device Registration (420)
- COFEPRIS Medical Device Approval (580)
- ANVISA Medical Device Registration Brazil (720)

## Contact Information
- Professional Email: jmclark@bioaccessla.com
- LinkedIn: https://www.linkedin.com/in/juliomartinezclark/
- Twitter/X: @jmartinezclark
- Instagram: @jmartinezclark
- Facebook: /jmartinezclark

## Companies
- bioaccess®: https://www.bioaccessla.com/
- Synapse Global Theranostics: https://synapseglobaltheranostics.com/
- amavita HEART AND VASCULAR HEALTH®: https://www.amavita.health/

## Site Structure for SEO
- Homepage: /
- Services Hub: /services
- First-in-Human Trials: /services/first-in-human
- Medical Device Registration: /services/medical-device-registration
- Radiopharma Trials: /services/radiopharma-trials
- INVIMA Approval Timeline: /services/invima-approval-timeline
- Colombia Clinical Trial Costs: /services/colombia-clinical-trial-costs
- ANVISA Registration Brazil: /services/anvisa-registration-brazil
- COFEPRIS Approval Mexico: /services/cofepris-approval-mexico
- ANMAT Registration Argentina: /services/anmat-registration-argentina
- Insights (FAQ & Glossary): /insights
- Case Studies: /case-studies
- Publications: /publications
- Speaking: /speaking

All pages available in English, Spanish (es-419), and Brazilian Portuguese (pt-BR).