The collection of good quality data from clinical trials is essential to data analysis to produce robust results that meet the precise requirements for regulatory need. Data from clinical trials are increasingly complex, related to involved protocols, the geography of trial sites, increasing data streams and technological advances. Therefore, studies must be set up to be efficient, offer support and training to trial sites and ensure that the right data are collected correctly.
Data Management teams have historically reviewed data once source document verification (SDV) has taken place by the Clinical Monitors on an ongoing basis. Data issues can be actioned early in the trial, and corrective action put in place. This activity has been a very manual process, thorough and time-consuming and has left less time to focus on insightful data analysis.
Collaboration: Data science and da…