AI-Managed Clinical Research Data Automation

This technical report discusses Parexel's strategy for implementing an AI-managed ecosystem for clinical research data. The report outlines the end-to-end automation approach that Parexel envisions, which includes data input, analysis, and regulatory submission. It emphasizes the importance of a robust technology foundation that integrates various data types and ensures data quality through governance principles. The document details the collaboration with Palantir Technologies to develop a custom SDTM transformation tool, enhancing the efficiency of clinical trial operations. Additionally, it describes the challenges of traditional SDTM transformation processes and how AI can streamline these tasks, ultimately reducing timelines and improving data accuracy. The report also highlights the significance of aligning people, processes, and technology to maximize the benefits of AI in drug development, aiming for operational efficiencies and better research outcomes.