Clinical Data Science (CDS) is defined as the strategic discipline enabling data driven Clinical Research approaches and ensuring subject protection as well as the reliability and credibility of trial results. Clinical Data Science encompasses processes, domain expertise, technologies, data analytics and Good Clinical Data Management Practices essential to prompt decision making throughout the life cycle of Clinical Research.
Clinical Data Management (CDM) is responsible for the life cycle of clinical data from collection to delivery for statistical analysis in support of regulatory activities. CDM is primarily focusing on dataflows and data integrity (i.e. data is managed the right way). CDS expands the scope of CDM by adding the data meaning and value dimensions (i.e. data is credible and reliable). CDS also requires the ability to generate knowledge and insights from clinical data to support clinical research which requires different expertise, approaches and technologies.