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SEND Creation and Data Warehouse solution for LifeSciences
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 SEND submission software enables life sciences organizations prepare SEND-compliant data sets ready for FDA submission.
Key Features
Savante streamlines the process of aggregating and consolidating nonclinical data coming from multiple sources, including internal studies and external partners. Additional features include:
SEND Standards
Data warehouse consolidates and formats study data based on SEND standards for easier reporting.
Savante creates SEND datasets based upon the SENDING standard and control terminology set date appropriate to your study start date.
Integrated solution with Spotfire makes nonclinical study data from in-house studies or partners accessible for cross study analysis and visualization.
Data Aggregation
Ability to ingest study data from disparate sources and formats for the purpose of creating SEND compliant datasets.
Automated Data Collection
Synchronization from Pristima XD 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 In Action
Savante provides a vehicle for preclinical data aggregation, analysis and visualization in SEND format to scientific staff and management.
Preclinical data from Pristima XD 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.
Data Analysis Capabilities using TIBCO Spotfire
Savante integrates with Spotfire to provide data visualization. This provides powerful, flexible access to all of 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 platfrom Pristima XD 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).
SEND Intelligence Services
Xybion provides data preparation services to securely receive your raw data, ingest the data into our system and automatically produce the Define.xml dataset and a templated nonclinical study data reviewer’s guide. We complete the study data reviewer’s guide in collaboration with you and securely return the complete package.
