OPP002 📄 Overview A comprehensive SaMD platform designed to facilitate decentralized clinical trials and real-world evidence generation. It provides tools for remote patient consent, secure multi-source data capture (wearables, ePRO, EHR integration), virtual patient visits, remote monitoring, and secure data analytics for researchers. The platform emphasizes patient experience, data integrity, and compliance. Key technologies: 👤 Target users: 👍 Benefits Reduced cost and time for clinical trials • Increased patient diversity and retention in trials • Enhanced real-world data collection for regulatory submissions • Accelerated development of new therapies and devices • Improved patient access to research opportunities Use bullets or new lines. 👎 Challenges Ensuring data security and privacy across decentralized sources • Standardizing data formats and interoperability • Regulatory acceptance of novel data collection methods (e.g., wearables as endpoints) • Training and supporting diverse patient populations remotely • Maintaining data quality and integrity in a decentralized environment 📋 Regulatory & Validation Compliance with GCP, HIPAA, GDPR, 21 CFR Part 11 for electronic records. • Validation of all software components as SaMD if used for critical trial functions. • Guidance on using digital health technologies for endpoints will be crucial.