Archives: Agenda

• Understanding the significance of selecting appropriate trial endpoints for study success
• Addressing challenges faced by midsize and small companies in conducting large-scale trials
• Highlighting the need to consider alternative endpoints for trials with limited resources
• Identifying essential information needed to demonstrate device safety and performance
• Discussing the interplay between regulatory requirements, safety considerations, and product development goals

• 2024 MDR deadlines
• 1Med’s expertise in MedTech
• Compliance tool for MDR Recertification
• 1Survey: real world data collection

• Comparing advantages and challenges of running trials in smaller countries vs established trial hubs.
• Analysing the significance of a comprehensive global strategy for clinical trials
• Addressing the rationale behind prioritising MDR compliance over US market entry
• Top tips and tricks for successful international expansion
• Evaluating the feasibility of running trials in multiple regions simultaneously

Medical device and diagnostics manufacturers are under increasing pressure to validate their products’ efficacy, safety, and cost-effectiveness across the entire lifecycle. Integrating clinical trials with real-world data (RWD) has emerged as a potent method for solving clinical evidence needs during and after clinical trials. This combined data is collected with minimal site or patient burden and unlocks novel insights into patient trajectories and outcomes, including patients lost to follow-up. This approach also reduces the potential burden on post-market surveillance with faster and deeper insights into patient safety and can lend itself to improved tracking of healthcare utilization.Directly linking trial insights with RWD represents a paradigm shift in how we consider evidence generation for medical device development. This session will explore the requirements, best practices, and latest industry trends in linking clinical trials to RWD.