LEVERAGING AI/ML IN STATISTICAL PROGRAMMING: ENHANCING EFFICIENCY, COMPLIANCE, AND INSIGHTS IN CLINICAL TRIALS

The integration of Artificial Intelligence (AI) and Machine Learning (ML) in statistical programming for clinical trials has revolutionized traditional research methodologies and data analysis approaches.This article examines how AI/ML technologies enhance efficiency, ensure regulatory compliance, and generate deeper insights in clinical trial processes.The article explores core applications including data cleaning, pattern recognition, and process automation, while analyzing the implementation of CDISC standards and documentation practices.Advanced analytics applications, particularly in statistical modeling and natural language processing, demonstrate significant improvements in trial management and patient monitoring.The article also investigates real-time analysis capabilities in adaptive trials and decision support systems, concluding with an examination of emerging technologies and implementation challenges in the field.This article highlights the transformative impact of AI/ML integration on clinical trial execution, data quality, and regulatory compliance while acknowledging the need for continued development of best practices and strategic implementation approaches.