Complete SEND Management System
SEND Creation and Data Warehouse solution for Life Sciences
SEND Creation and Data Warehouse solution for Life Sciences
Consolidating and validating data sets is a highly challenging and business-critical effort for many Contract Research Organizations (CROs) and drug developers who perform toxicology studies either internally or outsourced with external partners. Savante provides a mechanism for your organization to create, merge, validate, and visualize preclinical study data regardless of source or format.
Savante streamlines the process of aggregating and consolidating nonclinical data coming from multiple sources, including internal studies and external partners. Additional features include:
Integrated solution with Spotfire makes nonclinical study data from in-house studies or partners accessible for cross-study analysis and visualization.
Ability to ingest study data from disparate sources and formats to create SEND compliant datasets.
Synchronization from Pristima makes data collection from instruments seamless. Savante also accepts XPT formats from CROs or other systems & data can be augmented with data in CSV or Excel data files.
Savante integrates with Spotfire to provide data visualization. This provides powerful, flexible access to all your preclinical data from study directors, toxicologists, pathologists, and data scientists. The flexible query, analysis, and visualization capabilities support ongoing operational study monitoring as well as cross-study analysis from historical study data.
Savante as part of Xybion’s preclinical gold standard platform Pristima provides an automated solution for the creation and transport of SEND compliant datasets. The FDA has issued the final guidance on the Standard for Exchange of Nonclinical Data (SEND). Now, studies starting after Dec. 17, 2016, for applicable NDAs, BLAs, and ANDAs, and studies starting after Dec. 17, 2017, supporting IND submissions, must be submitted in accord with electronic standards specified by FDA (SEND for nonclinical).
Savante SEND submission software enables life sciences organizations to prepare SEND-compliant data sets ready for FDA submission.
Savante provides a vehicle for preclinical data aggregation, analysis, and visualization in SEND format to scientific staff and management.
Preclinical data from Pristima is automatically synchronized into the Savante repository. Data from other sources can be aggregated through migration and import, including direct loads of SEND data sets. The Savante toolkit handles the necessary consolidation, study merging, control terminology mapping, and data definition file preparation.