In the submission phase, all data related to a new drug or device will be submitted to different authorities following specific standards and formats. The regulatory authorities review the files and decide whether to approve or not.
Data-driven clinical trial feasibility and study design
New approaches to data management can boost efficiency and lead to better decision-making in drug development. In this whitepaper, we’ll go deeper into the current state of the art in managing clinical data and metadata that resides inside or outside an organization. Based on practical use cases, we explain the immediate and long-term impact of treating data as a valuable asset to achieve concrete business goals.
