Drug Evaluation Committee Evolution and Advancement of Data Management in Drug Development(Executive Summary)
Data Science Expert Committee
November 2025
The drug development landscape is undergoing an unprecedented transformation, driven by patient centric decentralized clinical trials (DCTs), the growing use of real-world data (RWD), rapid advances in AI and digital technologies, and the ongoing GCP Renovation. In this era of change, data managers should evolve beyond simply collecting and managing data. They are expected to become strategic contributors, engaging from the trial design stage and driving clinical trial success through data strategy planning and quality management. The key to optimizing the quality of clinical trial and enhancing efficiency lies in the strategic utilization of data managers. This document outlines the evolving role of data managers in response to increasingly diverse and complex clinical trials, and discusses the importance of optimizing organizational structures and developing talent to achieve such transformation, with a focus on the Japanese industry.
Please note that this document is English version of the executive summary originally prepared in Japanese as "Evolution and Advancement of Data Management in Drug Development(Executive Summary)". Full report is only available in Japanese.
2024 Data Science Expert Committee TF1-1
Drug Evaluation Committee
Japan Pharmaceutical Manufacturers Association