From faster approvals in Brazil to AI-driven design in Australia, this edition highlights the shifts helping sponsors move early-phase studies forward—faster and more effectively across Latin America and beyond: Discover why many sponsors are rethinking site selection Get up to speed o
ANVISA · AI
From faster approvals in Brazil to AI-driven design in Australia, this edition highlights the shifts helping sponsors move early-phase studies forward—faster and more effectively across Latin America, Latin America, and beyond.
Let’s dive in.
Despite being one of the most discussed areas in clinical trial planning, site selection remains one of the least optimized. Many sponsors continue to rely on prior experience and name recognition over data-backed operational readiness, leading to missed timelines and underperforming sites.
Smart site selection means looking beyond the usual suspects. For early-phase studies, it’s often the unknown sites that deliver the best outcomes.
Brazil’s health authority is launching a multi-year reform to streamline regulatory reviews for medical devices, medicines, and clinical trials. The plan includes hiring over 100 new health regulation specialists, modernizing systems, and introducing an AI-powered review engine called AnvisAI.
The U.S. is deepening economic ties with Argentina, Guatemala, Ecuador, and El Salvador through a series of new reciprocal trade frameworks. The agreements aim to open markets, ease tariffs, and streamline regulatory alignment—creating ripple effects that could support supply chains, cross-border investment, and long-term regional stability.
This trade recalibration signals a broader U.S. effort to bring manufacturing, supply chains, and clinical operations closer to home by investing in its regional partnerships.
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A new partnership brings together predictive analytics and clinical development expertise to help sponsors design smarter, more resilient early-phase studies. By pairing AI-based feasibility and risk modeling with real-world trial design, this collaboration aims to reduce uncertainty in Phase 1 and 2a studies—and speed up the path to market.
For Medtech innovators pursuing FDA clearance and patent protection in parallel, there’s a growing emphasis on aligning what’s disclosed in regulatory submissions with what’s filed at the patent office. Overlooking this connection can put a patent’s enforceability at risk—especially when technical data, comparative claims, or device performance statements made in a 510(k) submission could also be considered material to patentability.
Protecting innovation in the medical device space isn’t just about what’s new—it’s also about what gets disclosed, when, and where. Being proactive and consistent strengthens both regulatory and IP outcomes.
In early-phase clinical research, tight timelines, regulatory complexity, and regional variability demand more than just qualified staff—they require cohesive, high-performing teams that thrive under pressure. From feasibility to first-patient-in, success hinges on team alignment, leadership clarity, and a shared sense of mission.
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