Authors: Venkata Krishna, Bharadwaj Parasaram
Abstract: Clinical research faces critical challenges in scalability, data integrity, and regulatory compliance, particularly for large-scale NIH-sponsored trials (National Institutes of Health [NIH], 2023). This paper presents a cloud-based architecture leveraging Amazon Web Services (AWS) to address these challenges through three key innovations: (1) a HIPAA-compliant infrastructure with real- time data capture, (2) automated monitoring for FDA 21 CFR Part 11 compliance, and (3) nationally scalable deployment models.Our proposed architecture utilizes AWS Aurora PostgreSQL for electronic health record storage (Amazon Web Services [AWS], 2025) and Kinesis Data Streams for real-time ingestion of wearable device data (Smith et al., 2024). The system implements granular access controls through AWS Identity and Access Management (IAM), addressing NIH's emphasis on data security in multi-center trials (Collins & Tabak, 2024). Compliance features include automated audit trails via CloudTrail (U.S. Food and Drug Administration [FDA], 2022) and PHI detection using Macie (Johnson & Patel, 2024).Real-time dashboards built with QuickSight enable trial monitoring across 120+ sites, reducing protocol deviation detection time from 14 days to 48 hours in pilot testing (Légaré et al., 2023). The platform's national scalability is demonstrated through AWS Local Zones deployment, decreasing latency for rural sites by 72% compared to traditional models (Roberts et al., 2023). We evaluate this architecture against NIH's Strategic Plan for Data Science (NIH, 2023), highlighting its alignment with FAIR data principles while addressing persistent challenges in trial diversity enrollment (Bierer et al., 2022). The paper concludes with implementation guidelines for academic medical centers and cost-benefit analysis comparing cloud versus on-premises solutions (Mandel et al., 2024).
