What's Driving Clinical Data Innovation Now: Notes From The Front Lines Of Change

By Manny Vazquez

Clinical data management is undergoing a transformation as professionals shift from simply managing data to driving innovation that accelerates patient access to new therapies. In a series of forums held in Basel, New York City, and London, industry leaders discussed the emerging trends, initiatives, and challenges shaping this evolution. Key takeaways included the increasing prioritization of risk-based quality management (RBQM) over traditional methods like source data verification (SDV), with many biopharma companies now adopting risk-based clinical data management (RB-CDM) as a primary strategy. While artificial intelligence remains a topic of interest, its near-term impact is viewed with caution.

Collaboration with research sites and patients was another focus, emphasizing the need for user-friendly tools and better integration of site feedback in study design. The forums also highlighted the industry's move towards data science, urging a deeper involvement of data scientists in early trial phases to enhance efficiency and patient outcomes. As the industry evolves, the adoption of new technologies, skill sets, and mindsets is crucial.