Savante

Savante serves as a comprehensive software solution enabling Contract Research Organizations (CROs) and drug developers to efficiently manage and prepare SEND-compliant datasets for FDA submissions. This system facilitates the creation, merging, validation, and visualization of preclinical study data from diverse sources and formats.

Key features of Savante include:

• Data Aggregation: Capable of ingesting study data from various origins to produce SEND-compliant datasets, supporting integration with systems like Pristima and XPT formats.
• Data Warehouse: Utilizes SEND standards to format and consolidate study data, simplifying reporting processes.
• Data Analysis & Visualization: Incorporates TIBCO Spotfire for enhanced data visualization, allowing for flexible and powerful access to nonclinical study data, thereby facilitating cross-study analysis.
• Automated Data Collection: Synchronization from Pristima streamlines data gathering from instruments, with support for additional data formats like CSV and Excel.
• Compliance and Efficiency: Designed to minimize compliance risks, increase operational efficiency, and reduce costs by up to 30%.

Incorporating SEND standards as delineated by FDA guidelines, Savante ensures that studies initiated after specific deadlines comply with electronic submission mandates, supporting submissions for NDAs, BLAs, ANDAs, and INDs. This capability is crucial for organizations aiming to streamline their SEND submission processes.

Additionally, Savante integrates advanced data analysis capabilities, facilitating access for study directors, toxicologists, pathologists, and data scientists. By supporting ongoing monitoring and historical data analysis, it enhances both operational and strategic insights into preclinical studies.