ModernaTx, Inc., USA.
World Journal of Advanced Engineering Technology and Sciences, 2025, 15(01), 510-521
Article DOI: 10.30574/wjaets.2025.15.1.0236
Received on 25 February 2025; revised on 06 April 2025; accepted on 08 April 2025
Cloud-based platforms and artificial intelligence are transforming clinical trial data management, addressing critical challenges in an era of increasingly complex data requirements. Modern clinical trials generate vast volumes of information from diverse sources, including electronic health records, wearable devices, and laboratory systems, creating substantial management burdens while maintaining regulatory compliance. Traditional approaches suffer from siloed operations, manual processes, and scaling limitations that impact efficiency and data integrity. This article explores how cloud integration platforms provide secure, scalable infrastructure with enhanced security features, global accessibility, and regulatory-aligned validation capabilities. AI-driven analytics further revolutionize these processes through intelligent patient recruitment, enhanced quality management, and predictive optimization. By examining implementations across various therapeutic areas, including Moderna's COVID-19 vaccine development, we demonstrate how these technologies enable more efficient, cost-effective trials while maintaining compliance with stringent regulations like CFR 21 Part 11 and GxP standards.
Cloud Integration; Artificial Intelligence; Data Harmonization; Regulatory Compliance; Real-time Monitoring
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Rishi Nareshbhai Lad. Cloud and AI-driven innovations in clinical trial data management. World Journal of Advanced Engineering Technology and Sciences, 2025, 15(01), 510-521. Article DOI: https://doi.org/10.30574/wjaets.2025.15.1.0236.