How Savante Works

Data Consolidation & CDISC SEND Formats

Preclinical data from Xybion’s Pristima® platform 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.

Consolidating & Validating data sets is a highly challenging and business-critical effort for many Contract Research Organizations (CROs) & drug developers who perform toxicology studies either internally or outsourced to external partners. Savante enables you to support consistent views of merged study data and robust data analysis by allowing organizations to import, consolidate, and validate data sets from various sources.

Data Analysis Capabilities using TIBCO Spotfire

The Savante data warehouse can utilize Spotfire as a data visualization tool. This provides powerful, flexible access to all of your preclinical data by study directors, toxicologists, pathologists, and data scientists. The flexible querying, analysis and visualization capabilities support ongoing operational study monitoring as well as cross-study analysis from historical study data.

The CDISC SEND Mandate from the FDA

With the CDISC SEND format now required for electronic submissions to the FDA and regulatory bodies of other countries, the time is now to ensure your capabilities to create SEND data sets.

The CDISC Standard for the Exchange of Nonclinical Data (SEND) provides the structure and implementation rules for the submission of machines and human readable data sets. SEND is one of the required standards for data submission to the U.S. Food and Drug Administration (FDA) and specifies a way to collect and represent nonclinical data in a consistent format.

Savante is a turnkey solution that handles the necessary consolidation, study merging, controlled terminology mapping, and data definition file preparation – all within a validateable tool that is already in use by many of the leading CROs and Pharmaceutical companies in the industry.

Key Features:

  • Consolidate and format study data based on CDISC SEND standards
  • Consolidate data in from a variety of formats and assemble it into a SEND-compliant format
  • Data aggregation from multiple sources: Savante takes in data from a variety of formats and consolidates it, assembling it into a SEND-compliant format. The define.xml file that is required as part of the submission is created automatically
  • Automated data collection: Synchronization from the Pristima data capture system makes data collection from instruments seamless. In addition, Savante can accept XPT format from CROs or other systems, and this data can be augmented with data in CSV or Excel data files
  • Flexible data analysis and visualization: Savante offers an integrated solution with Spotfire for making nonclinical study data from in-house studies or partners accessible for cross study analysis and visualization