Blockchain and AI: Transforming Clinical Trials and Regulatory Compliance in Pharma

Abstract

Clinical trials and regulatory compliance are foundational pillars of pharmaceutical development, yet they are frequently hampered by issues related to data integrity, patient privacy, process inefficiencies, and regulatory transparency. As the pharmaceutical industry moves toward a digital-first paradigm, the integration of Blockchain technology and Artificial Intelligence (AI) offers transformative potential. This review explores how the convergence of these technologies can address existing challenges in clinical trials while streamlining regulatory processes.

Blockchain, known for its immutable and decentralized ledger system, ensures tamper-proof recordkeeping, real-time auditability, and secure patient data management. AI, with its predictive analytics and pattern recognition capabilities, supports adaptive trial designs, optimizes patient recruitment, and detects anomalies in large datasets. Combined, these technologies can automate compliance checks, enable smart contract execution for trial milestones, and foster trust across stakeholders including sponsors, investigators, regulators, and patients.

This paper offers a detailed examination of recent literature, highlighting real-world implementations and emerging frameworks. It presents various AI algorithms used in trial optimization, alongside blockchain architectures designed for secure data sharing and smart contract deployment. The review also formulates key problems, introduces conceptual and proposed methods, and evaluates outcomes from recent case studies. While the integration of these technologies remains in its nascent stage, the results are promising and point toward a future of more efficient, secure, and transparent pharmaceutical development.

DOI: 10.8612/40.2.2025.3