Precision Data Management: Using REDCap and Large Language Models to Optimise Clinical Trial Efficiency

Robust data management is fundamental to the success of clinical trials, particularly those conducted across multiple sites. This paper outlines a precision data management approach that integrates REDCap with large language models (LLMs) to support the automation of key trial processes. These include online participant pre-screening, AI-assisted CRF review, LLM-driven data cleaning, automated MedDRA coding, and real-time data locking. Embedding these tools in existing workflows has led to measurable improvements in data quality, reductions in manual workload, and enhanced operational efficiency. This approach is scalable and adaptable, offering a practical model for modernising data operations in diverse clinical research settings.