Global Trial Accelerators™

💊 Breakthrough Drugs Reshaping Clinical Trial Landscape

Permitted Daily Exposure (PDE) is a crucial concept in drug safety. It sets the maximum daily amount of a potentially harmful substance that a person can be exposed to without adverse health effects.

Key Points:

• PDE helps ensure drug safety by setting exposure limits
• Regulatory bodies like ICH and EMA provide PDE guidelines
• Calculation involves No Observed Adverse Effect Level (NOAEL)
• Safety factors account for human variability and other risks
• PDE impacts clinical trial design and regulatory approval

Why It Matters: Understanding and adhering to PDE limits protects patients, ensures regulatory compliance, and increases the likelihood of drug approval.

What’s PDE and Why It’s Key to Ensuring Drug Safety

🔬 Reimagining Clinical Trials Across Emerging Markets

IAOCR and GCSA, leading clinical research accreditation bodies, have launched certification programs in Latin America. This expansion allows regional stakeholders to meet global standards, minimize trial risks, and attract international sponsors.

Key Points:

• Latin American sites can now access IAOCR's UNESCO-aligned certifications
• GCSA's patient-centric site assessments are now available in the region
• New regional hub at iaocramericas.com supports certification processes
• Partnerships formed with bioaccess®, health agencies, and Macondo Labs
• Cancer trial participation in Latin America expected to grow 66% by 2040

Why It Matters: These certifications position Latin America as a competitive player in global clinical research, potentially accelerating drug development and improving patient access to innovative treatments.

Run Faster, Stay Sharp: Clinical Trials Reimagined

🌎 Gene Therapies in Chile: Overcoming Regulatory Gaps

Obtaining ISO 13485 certification is a critical process for medical device companies. It involves careful planning, developing quality systems, and overcoming various challenges.

Key Points:

• Understand ISO 13485 principles like customer focus and continuous improvement
• Plan and develop a comprehensive quality management system
• Conduct gap analyses to identify areas needing improvement
• Train employees and foster a culture of quality throughout the organization
• Address common challenges like documentation issues and resource constraints

Why It Matters: Achieving ISO 13485 certification demonstrates your commitment to quality and safety, giving you a competitive edge in the medical device industry.

ISO 13485: Your Gateway to Global Market Access

🧪 New Pharma Rules Reshape Global Clinical Trials

Clinical trials are complex but crucial for advancing medical treatments. Understanding the process, planning effectively, and engaging participants are key to success.

Key Points:

• Clinical trials progress through four main phases, each with specific goals
• Careful planning and execution are essential for trial success
• Site selection and regulatory approvals play critical roles
• Effective recruitment strategies boost participant engagement
• Ongoing communication maintains participant commitment throughout the study

Why It Matters: Mastering these elements can accelerate the development of life-changing treatments while fostering economic growth in emerging research hubs.

Ready to Lead Clinical Trials with Confidence?

🚀 Launching Globally: Your 60-Day MedTech Trial Roadmap

Join us as we delve into the journey of Julio G. Martinez-Clark, co-founder and CEO of bioaccess®, a U.S.-based Contract Research Organization (CRO) revolutionizing medical technology access in Latin America. Discover how Julio's innovative approach is accelerating first-in-human and early feasibility studies, offering 40% faster approvals and 30% lower costs for MedTech and Biopharma companies.

$30B Trial Bottleneck—Julio Martinez-Clark’s 60-Day Fix

🌎 Simplifying Global Medtech Trials: Colombia to Albania

Julio Martinez-Clark, CEO of bioaccess®, shares his insights on the current state of the Medtech industry in a podcast interview with Adam Torres. The discussion delves into the trends shaping this rapidly evolving sector.

Key Points:

• Julio Martinez-Clark offers expert perspective on Medtech trends
• The podcast explores the CEO's professional journey in the industry
• Current challenges and opportunities in Medtech are discussed
• Insights into future directions for medical technology are shared
• The interview provides valuable information for industry professionals

Why It Matters: This discussion offers Medtech and Biopharma professionals a glimpse into industry trends, potentially influencing their strategies for clinical trials and market entry.

From Telecom to Trials: Julio Martinez-Clark’s Medtech Impact

🌎 Expand Your MedTech Trials to New Global Frontiers

Zach Selch is the VP of Global Sales for a high tech medical company and coaches and mentors Global Sales Leaders. Over 30 years he has sold in more than 135 countries, lived in 6 countries, and has driven 4 digit sales growth multiple times while adding hundreds of millions of dollars to the value of companies by building their international footprint.

Why Colombia Is the Gateway to Latin America's Medical Sales Market

🏥 Discover Why Medtech Trials are Moving South

Designing clinical trials for medical devices in Paraguay requires careful planning and regulatory compliance. Here are the key steps to ensure successful trials:

Key Points:

• Define clear objectives and select appropriate study design
• Calculate required sample size based on statistical needs
• Develop detailed protocol and obtain ethics committee approval
• Submit necessary documentation to DINAVISA for regulatory approval
• Implement effective participant recruitment strategies

Why It Matters: Following these steps helps medical device companies conduct ethical, compliant trials that advance healthcare innovation in Latin America.

Want to Run Clinical Trials in Paraguay? Here’s What You Need to Know

🩸 One Blood Draw Redefines Clinical Research in Latin America

bioaccess.™ offers comprehensive support for medical device companies entering Latin American markets. This US-based CRO provides end-to-end services from initial research to full commercialization.

Key Points:

• Specializes in Colombian and Latin American markets
• Offers regulatory and market access consulting
• Provides contract research organization services
• Supports companies from bench to commercialization
• Focuses on long-term success for foreign medical device firms

Why It Matters: Partnering with bioaccess.™ streamlines market entry and regulatory compliance for medical device companies in Latin America, potentially saving time and resources.

bioaccess.™: Your Strategic Advantage in Latin America

🌎 Latin America: The new frontier for medtech trials

Latin American clinical research sites execute 13% of global trials, yet face significant challenges in securing their position within the international research landscape. This striking disparity demands immediate attention and strategic solutions. Clinical research excellence demands rigorous qua

Why Latin America Clinical Research Professionals Need the IAOCR Accreditation Now