Case of establishment of a SEND data utilizing system through a cross-study data integration and visualization in a pharmaceutical company

Abstract

The FDA requires submission of electronic data compliant with SEND for some non-clinical safety studies at the IND and NDA. Since SEND data accurately reflects non-clinical safety data and the format is standardized, it is suitable for visualization and analysis, and is expected to increase the efficiency of safety assessments. Many pharmaceutical companies are now trying to use SEND data not only for FDA applications, but also for non-clinical safety assessments by themselves. However, there are challenges at each step in the utilization of SEND data, including data creation, data management, data integration among studies, data visualization and data analysis. We have been working to establish a system to integrate, visualize and analyze SEND data across non-clinical safety studies in order to maximize the use of our non-clinical safety data and to improve the efficiency and accuracy of safety assessments. Currently, the visualization of non-clinical safety data is contributing to intuitive understanding of the data, leading to faster evaluation of each study. In addition, the visualization and analysis of cross-study data has provided deeper insights into the relationships among various evaluation items, species differences in results and finding/lesion progression by extension of dosing periods. In this presentation, we will introduce our specific efforts and methods of establishing a SEND data utilization system at our company, as well as show cases of analysis using our database.