bioaccess® – Specialized MedTech Contract Research Organization in Latin America

1. bioaccess® & The Future of Contract Research Organizations bioaccess® is a specialized Contract Research Organization (CRO) for medical devices in Latin America, offering clinical trial management, regulatory support, and market access services to accelerate regional product approvals. https://www.bioaccessla.com/

2. What Is a Contract Research Organization (CRO)? ContractResearch Organizationsare specializedpartners that enable pharmaceutical, biotechnology, and medical device companies to bring life-saving innovations to market faster and more efficiently. CROs manage the complex orchestration of clinical trials4from project management and regulatory compliance to data collection and quality assurance4allowing sponsors to focus their resources on core R&D and innovation. By leveraging CRO expertise, companies accelerate timelines, reduce costs, and ensure trials meet the highest quality standards required for regulatory approval. https://www.bioaccessla.com/

3. bioaccess®: Fast-Tracking Clinical Trials Globally 22-PersonExpertTeam Dedicated professionals specializing in fast-track trial execution and global compliance Founded2010 Miami-basedCROwith deep expertise in emerging markets and regulatory acceleration strategies Strategic Global Reach Operating across LatinAmerica,Eastern Europe, and Australia with pre- qualified clinical sites bioaccess® accelerates first-in-human and early feasibility studies 40% faster than traditional US/EU pathways, enabling sponsors to reach critical milestones and investor readiness months ahead of schedule.

4. Dramatic Time & Cost Advantages 4-8 WeekstoEthics Approval LatinAmericaethicscommittees vs.6+monthsinUS/EU regulatory pathways 5-10 DaystoTGAResponse Australia'sTherapeuticGoods Administrationprovidesrapid acknowledgmentforexpedited trials 35% PhaseICostReduction Australia'sstreamlined CTN process dramatically cuts early- stage development expenses 30% Lower Trial Costs Savingapproximately$25,000 perpatientthroughstrategicsi te partnerships Pre-negotiated contracts with premier clinical sites eliminate lengthy procurement cycles, while favorable regulatory environments deliver unprecedented speed without compromising data quality or compliance.

5. Regulatory Expertise & Global Compliance FDA/EMA-ReadyData 100%ICH-GCP complianceensures seamless regulatory acceptance in major markets4no costly data rework or re- submissions required Parallel Review Process Serbia's ADISportalenables simultaneous ethics and regulatory review, achieving approvals in just 80 days Rapid Colombian Pathway Colombia'sMinistry ofHealth accelerates trial evaluation with 30- 90 day timelines for life-saving innovations

6. Strategic Global Network & Patient Recruitment 50+ Pre-Qualified Sites Extensivenetwork ofclinicalsites activated in under 8 weeks, eliminating months of qualification and negotiation delays Diverse Patient Populations Access rarediseasecohortsin Kosovo,cardiology specialists in Belgrade, and unique demographic profiles across regions Partnership Success GlobalCare ClinicalTrials collaboration achieved 50% faster recruitment with exceptional 95% patient retention rates bioaccess®'s established relationships with premier clinical sites and principal investigators ensure rapid enrollment and high-quality data collection across therapeutic areas.

7. Real-World Impact: Testimonials from Innovators DigitalHealthCEO BiopharmaFounder "Our Serbia site was activated 9 months faster than EU alternatives. bioaccess® turned what seemed impossible into our competitive advantage." "Australia's CTN process through bioaccess® slashed our Phase I costs by over a third. The savings allowed us to extend our runway and accelerate development." bioaccess® empowers startups and emerging companies to achieve critical milestones faster, demonstrating compelling clinical proof-of- concept that attracts investors and strategic partners while significantly reducing cash burn.

8. bioaccess® vs Traditional CROs: A Visual Comparison 1 TraditionalUS/EUPath 6+monthsforethicsand regulatory approvals Higher per-patient costs, longer site activation 2 bioaccess® Latin America 4-8 weekstoethics approval 30% cost reduction, rapid site activation 3 bioaccess® Australia 5-10 days TGAacknowledgment 35% Phase I cost savings via CTN pathway Cut Your Trial Timeline by Up to 40% The difference between traditional and bioaccess® pathways can mean reaching pivotal milestones 6-9 months earlier4a competitive advantage that can transform company valuation and market positioning.

9. Why Medtech Startups Choose bioaccess® End-to-EndAcceleration Comprehensivesupportfrom pilotstudy design through commercialization, ensuring seamless progression through development stages Deep Regional Expertise Unparalleledregulatoryknowledgecombined with global standards compliance4local insights with worldwide credibility De-Risk Development Generatecost-effective, high-quality clinical data that validates technology and attracts investment for early- stage innovations For resource-constrained startups, bioaccess® delivers the speed and efficiency needed to demonstrate clinical value before capital runs out, creating compelling investment narratives backed by solid data.

10. The Future of Clinical Trials is Faster, Smarter, Global Accelerate with Confidence Bridge Innovation & Markets bioaccess® connects breakthrough technologies with untapped global clinical sites and patient populations Achieve regulatory-grade data 40% faster while maintaining the highest quality and compliance standards Every Month Counts Incompetitive markets,speed to market can determine success4start your trial faster and reach patients sooner Ready to transform your clinical development timeline? Partner with bioaccess® to accelerate your breakthrough medical device or pharmaceutical innovation, reduce costs, and achieve global regulatory success faster than you thought possible. Start Your Accelerated Trial