Veeva：2025年全球临床数据趋势报告（英文版）

Regulators have long encouraged risk-based approaches to quality management (RBQM) and are now applying the same principles to data management and monitoring. ICH guideline E8(R1) asks sponsors to consider criticalto-quality factors in clinical research and manage “risks to those factors using a risk-proportionate approach”.1 Given ever-expanding data volumes, it is not sustainable for biopharma companies to scale data management linearly using traditional methodologies. With regulators now s