OPP003_DecentralizedTrialRWEPlatform 📄 Overview A comprehensive platform that integrates various SaMDs (wearables, digital therapeutics, ePRO tools) to facilitate decentralized clinical trials (DCTs). This platform would enable remote data collection, patient engagement, and real-time monitoring, simultaneously generating high-quality Real-World Evidence (RWE) for post-market surveillance and new indication discovery. Key technologies: 👤 Target users: 👍 Benefits Reduced cost and time for clinical trials • Increased patient diversity and access to trials • Faster drug/device approval cycles • Continuous generation of RWE for regulatory submissions and market access • Improved patient experience in trials Use bullets or new lines. 👎 Challenges Regulatory acceptance of RWE for primary endpoints • Ensuring data quality and integrity from diverse sources • Maintaining patient privacy and consent management • Standardization across different SaMDs and data formats • Infrastructure and logistical challenges for remote patient support 📋 Regulatory & Validation Individual SaMD components will require their own regulatory clearance. The platform itself, as a tool for clinical trials, will need to meet GxP (Good Clinical Practice, Good Manufacturing Practice) standards. Emphasis on data integrity, traceability, and audit trails.