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Preclinical Data and Query Solution for CDISC-SEND

Savante™ is a data repository, query, and automated pre-clinical data preparation solution to support CDISC SEND submission standards and is integrated with the industry’s leading analytics and data exploration products.

Savante™, is a comprehensive solution for data aggregation, query, analysis, and reporting of pre-clinical drug discovery and drug development data. Integrated with the industry-standard Pristima® pre-clinical software suite, it allows organizations to build a consolidated data warehouse containing study data coalesced from multiple sources, based on CDISC-SEND standards.

How Savante™ Works

SEND savante

Data Consolidation & CDISC-SEND Formats

Pre-clinical 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 datasets. Savante toolkit handles the necessary consolidation, study merging, control terminology mapping, and data definition file preparation.

With many organizations performing toxicology studies both internally and with external partners, consolidating and validating data sets is a business critical activity. By allowing you to import, consolidate, and validate data sets from various sources, Savante enables you to support consistent views of study data and robust data analysis.

Data Analysis Capabilities using TIBCO Spotfire®

The Savante™ data warehouse utilizes TIBCO’s Spotfire® as the data visualization tool, which provides powerful, flexible access to all of your pre-clinical data by study directors, toxicologists, pathologists, and data scientists. The flexible querying, analysis and visualization capabilities support on-going operational study monitoring as well as cross-study analysis from historical study data.

The CDSIC-SEND Mandate from the FDA

With the CDISC-SEND format emerging as the required format for electronic submissions in the near future, the time is right to pursue readiness planning. Savante™ is a turn-key solution that handles the necessary consolidation, study merging, control terminology mapping, and data definition file preparation – all within a validatable tool that is already in production by many of the leading CROs and pharmaceutical companies in the industry.

Key Features:

  • The consolidation and formatting of study data based on CDISC-SEND standards.
  • Take data in from a variety of formats and consolidate it, assembling 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 TIBCO’s Spotfire® for making non clinical study data from in-house studies or partners accessible for cross study analysis and visualization.

Key Benefits:

  • Savante™  streamlines the process of aggregating and consolidating nonclinical data coming from multiple sources, including internal studies and external partners. In addition, the data can be automatically formatted to meet the latest CDISC-SEND specifications, allowing you to focus on core business activities and reduce the organizational risk associated with managing disparate data sets.
  • Flexible data analysis and visualization using TIBCO’s Spotfire® platform enables self-service of the data by multiple stakeholders, allowing you to maximize the value of your nonclinical data repository.
  • Savante™ allows selection of SEND IG specification version (3.0, 3.1 and future versions to be implemented), and Control Terminology set (they are issued quarterly) at output time. As the standards evolve, so does Savante™ so that you can deliver your data to the latest standards.
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