Data Governance In The Clinical Trial Ecosystem

By Jaime Cook, Executive Vice President, Technical Delivery

Data are the lifeblood of the drug development process. Expanding volumes of data, multiple data formats and dependence on an increasing number of eClinical systems make data governance essential for the efficient management of data assets across the research and development value chain. Data governance aligns people, processes, and information technology to optimize the use and value of data across a business enterprise. This formal practice helps sponsors collect, integrate, and analyze data strategically to advance their drug development programs.

Good data governance delivers significant competitive advantage. A high-functioning clinical ecosystem drives better decision-making, operational efficiencies to reduce time and cost, and regulatory compliance to avoid costly errors and rework. In this article, we discuss how the principles of data governance are used to build a business intelligence framework that advances data quality, acquisition, and integration to deliver actionable information for use across the drug development enterprise.