A leading Pharma Company adopts Xybion's Savante™ for CDISC-SEND Data Aggregation, Visualization, and Reporting
This case study helps you learn how to lower the organizational risk associated with critical non-clinical datasets required for FDA submissions.
A global Pharmaceutical Company was unable to meet CDISC-SEND compliance needs with its internal SEND repository and research toolset. The repository relied on manual data assembly and had limited integration and data visualization capabilities. In addition, the customer had deployment challenges in a GLP environment.
Thus, the Pharma Company adopted Xybion’s Savante™ Platform to enable key functions, such as importing datasets from customer’s CRO partners, facilitating SEND validation, and assembling the dataset into a submission-ready package based on CDISC-SEND standards.