Outlook For 2025: New Forces Driving Pragmatic Innovation

By Drew Garty, Chief Technology Officer,
Veeva Clinical Data

Clinical data trends are evolving rapidly, driven by regulatory support, advanced technology, and a shift toward risk-based approaches. This transformation emphasizes critical-to-quality factors, enabling biopharma teams to focus on key data points rather than exhaustive reviews. Real-world applications showcase significant efficiency gains, such as streamlined source data verification and automated queries, reducing manual workloads across thousands of visits.

The field of clinical data management is transitioning into clinical data science, with professionals leveraging automation and analytics to enhance decision-making. This evolution fosters cross-functional collaboration and better integration of patient data, supported by emerging AI-driven tools and endpoint-driven design strategies. Decentralized clinical trials (DCTs) prioritize patient optionality, simplifying participation through hybrid models and BYOD policies while enhancing data quality. Metadata-driven repositories (MDRs) and data standards are reemerging as streamlined approaches, accelerating study design and database lock processes. Enhanced data ownership models and transparent live data access empower sponsors, aligning with diversity initiatives and the demand for resilient, future-focused clinical data frameworks. These trends collectively aim to reduce trial complexity, improve patient experiences, and shorten development timelines.