🇨🇴 Ready for Colombia’s clinical trial revolution?
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🇧🇷 Inside Brazil’s MedTech Momentum
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🚀 First-in-Human Trials: Why LATAM Is Gaining Speed
Hospital Internacional de Colombia (HIC) is set to obtain GCSA certification, marking a significant milestone for clinical research in Latin America. This development strengthens HIC's partnership with bioaccess®, the leading first-in-human CRO in the region. Key Points: Why It Matters: This certification enhances the quality and credibility of clinical trials conducted in Latin America, offering medtech and biopharma companies access to world-class research facilities and expertise.
🔬 Where Smart Trials Meet Rising Global Standards
The Helsinki Report outlines crucial ethical guidelines for clinical research directors conducting studies with human subjects. These insights ensure participant safety, maintain research integrity, and promote transparency in medical trials. Key Points: Why It Matters: Adhering to these ethical principles safeguards participants, builds trust in clinical research, and accelerates the development of life-saving medical innovations.
💊 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: Why It Matters: Understanding and adhering to PDE limits protects patients, ensures regulatory compliance, and increases the likelihood of drug approval.
🔬 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: 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.
🌎 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: Why It Matters: Achieving ISO 13485 certification demonstrates your commitment to quality and safety, giving you a competitive edge in the medical device industry.
🧪 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: Why It Matters: Mastering these elements can accelerate the development of life-changing treatments while fostering economic growth in emerging research hubs.
🚀 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.
🌎 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: 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.