Data management


Bridging silos for smarter clinical trials


The landscape of clinical trials is increasingly complex, with data playing a pivotal role in shaping research outcomes. Data management, biostatistics, and data standards are essential pillars of this ecosystem, yet they often operate in silos. Adding external vendors to the equation further fragments the process, potentially leading to inefficiencies and compromised data integrity. To achieve transparency, efficiency, and robust data integrity, the industry must address these silos and foster seamless collaboration across all stakeholders. Phoebe Galbraith speaks to Mike Martin, principal, and Bazgha Qutab, principal, at ZS Associates.


D


ata is the backbone of clinical trials, driving decision-making from design to submission. Traditionally, the data management life cycle includes database creation, data entry, and database lock – all culminating in regulatory submissions. This foundational process ensures


that trial data is of high quality and fit for analysis, the landscape has evolved significantly, however, in recent years. New data sources, including wearables, synthetic data, and real-world evidence, have emerged, adding both opportunities and challenges to the equation. Despite these advances,


Clinical Trials Insight / www.worldpharmaceuticals.net


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