Clinical study management encompasses all activities of a clinical study, and the ability to quickly and efficiently assess a study's development and progress at any given moment. Clinical studies entail an ever changing and growing collection of data, activities and relationships that change from day to day, and visibility into critical events is essential to the success of a clinical trial. Complete clinical management combines the activities traditionally managed by clinical operations and those of clinical quality for a holistic approach to embedding quality into day-to-day clinical operations.
Successfully managing the quality of clinical studies, regardless of size, requires more than just a centralized place to house electronic trial master file (eTMF) documents. Clinical quality management must include the ability to assess the criticality and impact that the information has on the various aspects of a clinical trial. Understanding how information relates to the overall success and risk of a clinical trial becomes the true value of a clinical quality management system.