Global Trial Accelerators™

🌐 LATAM’s growing role in early-phase trials

Clinical trial websites implement comprehensive cookie frameworks to manage user data collection and maintain regulatory compliance across multiple jurisdictions. These systems categorize cookies into necessary, functional, analytical, performance, and advertisement types, each serving specific operational requirements for research platforms.

Key Points:

• Necessary cookies maintain essential site functions including secure authentication and consent preference management
• Analytical cookies track user behavior patterns and site performance metrics through Google Analytics and HubSpot integration
• Functional cookies enable social media integration and third-party platform connectivity for research collaboration
• Advertisement cookies facilitate targeted content delivery and campaign effectiveness measurement via DoubleClick systems
• Performance cookies monitor website speed and user experience optimization across clinical trial management platforms

Why It Matters: Proper cookie management ensures regulatory compliance while maintaining seamless user experiences for clinical research professionals navigating complex trial management platforms.

Australia Opens the Door to Faster Approvals

🧬 What’s New in Gene Therapy? FDA Approves a First

The FDA has approved Waskyra, the first gene therapy treatment for Wiskott-Aldrich syndrome, marking a significant regulatory precedent for rare disease therapeutics. This approval demonstrates how regulatory agencies are adapting their frameworks to accelerate access to life-saving treatments for underserved patient populations.

Key Points:

• Waskyra uses patients' own genetically modified hematopoietic stem cells to treat the underlying genetic cause of Wiskott-Aldrich syndrome
• Clinical studies showed 93% reduction in severe infections and 60% reduction in bleeding events within the first year post-treatment
• FDA exercised regulatory flexibility across trial design, manufacturing controls, and data requirements to expedite approval for this rare disease
• Approval was based on data from two open-label studies and expanded access programs involving 27 patients with severe disease
• Fondazione Telethon ETS becomes the first non-profit organization to receive FDA approval for a cell and gene therapy product

Why It Matters: This approval establishes a regulatory pathway that could accelerate development timelines and reduce barriers for innovative therapies targeting rare diseases with limited treatment options.

FDA Approves First Gene Therapy Treatment for Wiskott-Aldrich Syndrome

🇷🇸 Serbia fast-tracks early-phase trial approvals

Serbia's regulatory framework for vaccine trials has evolved significantly since the early 19th century, with the Medicines and Medical Devices Agency of Serbia (ALIMS) now serving as the primary oversight body. This streamlined system offers efficient pathways for clinical research while maintaining rigorous safety and ethical standards.

Key Points:

• ALIMS completes regulatory assessments within 60 days while local ethics committees typically provide approvals within 30 days
• Serbia has approved 452 clinical studies since 2023, demonstrating an active and supportive regulatory environment
• The 2010 Law on Medicines and Medical Devices aligned Serbian standards with European Union requirements
• Local representatives can serve as regulatory proxies to facilitate communication with ALIMS throughout the approval process
• Recent streamlining efforts have reduced some study approvals to as little as three weeks for qualifying protocols

Why It Matters: Serbia's efficient regulatory framework and EU-aligned standards provide medtech companies with faster market access while maintaining the rigorous oversight required for successful vaccine development programs.

Serbia Steps Up: A Smoother Route for Vaccine and Early-Phase Trials

🧬 First-in-human gene therapy shows early promise

Modern websites deploy sophisticated cookie tracking systems that monitor user behavior, store preferences, and enable personalized experiences. These digital identifiers serve multiple functions across security, analytics, marketing, and operational requirements.

Key Points:

• Necessary cookies maintain essential site functions including secure login authentication and fraud prevention protocols
• Functional cookies enable social media integration, video preferences, and third-party service connectivity
• Analytical cookies track visitor patterns, session data, and site performance metrics for optimization purposes
• Performance cookies regulate data collection rates and manage system resources on high-traffic platforms
• Advertisement cookies deliver targeted content based on browsing history and measure campaign effectiveness

Why It Matters: Understanding cookie categories helps organizations implement compliant data collection strategies while maintaining operational efficiency and user experience standards.

Scaling Medtech Trials in Latin America with Precision and Speed

🧬 CRISPR breakthrough changes clinical trial landscape

Modern healthcare websites collect extensive data through sophisticated cookie systems that track user behavior, preferences, and interactions across multiple platforms and sessions.

Key Points:

• Necessary cookies maintain essential site security functions including fraud prevention, user authentication, and cross-site request protection
• Functional cookies integrate third-party services like LinkedIn, YouTube, and Calendly to support professional networking and scheduling capabilities
• Analytical cookies from Google Analytics and Typeform measure site performance, visitor patterns, and user engagement metrics
• Performance cookies optimize loading speeds and data collection rates to improve overall website responsiveness
• Advertisement cookies track user behavior across platforms to deliver targeted marketing content and measure campaign effectiveness

Why It Matters: Understanding cookie categories helps clinical trial professionals make informed privacy decisions while accessing critical research platforms and regulatory resources.

Avoid FDA 510(k) Pitfalls: 4 Proven Steps for Medtech Sponsors

🤖 AI meets early-phase trials in Australia

We use cookies to help you navigate efficiently and perform certain functions. You will find detailed information about all cookies under each consent category below. The cookies that are categorised as "Necessary" are stored on your browser as they are essential for enabling the basic functionalities of the site. ... Necessary cookies are required to enable the basic features of this site, such

Why Most Site Selection Strategies Still Miss the Mark

🧬 FDA expands options for rare disease trials

FDA Expands Trial Options for Rare Disease Therapies

El Salvador Hosts World-First Robotic Eye Surgery 🌎

A pioneering RNA therapy being developed in Melbourne could transform the treatment of lupus, offering new hope to thousands of Australians living with the chronic autoimmune disease.

Australia Launches RNA-Based FIH Trial for Lupus

What Mexico’s EU Deal Means for Medtech 🌐

Friday 24 October 2025 Latin America seeks to quadruple its participation in clinical trials Clinical research is essential to developing new treatment options, improving diagnostic tools, and advancing disease prevention. These efforts not only extend life expectancy and reduce mortality rates but also contribute significantly to the social and economic development of nations. Yet despite its po

LATAM Aims Big: Clinical Trial Participation Could Quadruple

🧬 LatAm Unifies Regulations Across Eight Nations

We use cookies to help you navigate efficiently and perform certain functions. You will find detailed information about all cookies under each consent category below. The cookies that are categorised as "Necessary" are stored on your browser as they are essential for enabling the basic functionalities of the site. ... Necessary cookies are required to enable the basic features of this site, such

Balkans as a Pre-MDR Testing Ground