Savante® is a data repository, query, and automated preclinical data preparation solution to support CDISC SEND submission standards. Savante 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 preclinical toxicity and safety predictions including toxicokinetic data, which are acquired through nonclinical animal studies. Integrated with the industry-standard Pristima® Core preclinical software, it allows organizations to build a consolidated data warehouse containing study data coalesced from multiple sources, based on CDISC SEND standards. Thus, Xybion’s SEND Submission Software enables Life Sciences organizations to prepare SEND-compliant data sets ready for FDA submission.

How Savante Works

Data Consolidation & CDISC SEND Submission 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 with 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 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.

The CDSIC SEND Mandate from the FDA

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

What is SEND

The CDISC (Clinical Data Interchange Standards Consortium) Standard for the Exchange of Nonclinical Data (SEND) provides the structure and implementation rules for submission of machine- 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 production by many of the leading CROs and Pharmaceutical companies in the industry.

Key Features:

  • Consolidation and formatting of study data: Based on CDISC SEND standards
  • Data aggregation from multiple sources: Savante takes in data from a variety of formats and consolidates it, assembling it into a FDA 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

Savante Key Features:

  • 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 the 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, DART 1.1 and future versions to be implemented), and Control Terminology set (issued quarterly) at output time. As the standards evolve, so does Savante so that you can deliver your data to the latest standards.

Pristima SEND Submission Management

Pristima Core provides a module to facilitate the CDISC SEND standards for preclinical data submissions. The Standard for Exchange of Nonclinical Data (SEND) is an implementation of the Study Data Tabulation Model for nonclinical studies. This standard was developed by the Clinical Data Interchange Standards Consortium’s (CDISC) SEND.

Standard for Exchange of Nonclinical Data (SEND) is the content standard set by the FDA for the submission of preclinical safety assessment data. By creating a recognized standard for submission data, SEND facilitates communication between research organizations, sponsors, and regulators.

The Pristima Savante SEND component is fully integrated with Pristima Core Data Management and is designed to comply with the FDA regulatory guidelines and standards. Acting as a channel to concentrate and reformat preclinical data, the Pristima Savante SEND component is designed to support CDISC SEND compliant data submissions to the FDA from a variety of data sources, including Pristima, Xybion’s legacy PATH/TOX SYSTEM and other third party data management systems such as those used for toxicokinetic data management.

Xybion designed the Savante SEND component to adhere to the current CDISC standards. As an Associate Member of CDISC (Clinical Data Interchange Standards Consortium), Xybion has a thorough understanding of CDISC requirements and best practices. Additionally, working globally in close cooperation with Pharmaceutical industries/CROs to identify value-add capabilities, Xybion has developed the Savante SEND module with a transfer mechanism to facilitate the exchange of data between the CRO and sponsor.

Pristima data collection customers benefit from a seamless integration of these applications and a friendly user interface that provides the user with guides and queues to complete the submission.

Pristima® Core is a comprehensive Research and Safety study management application. The system offers advanced capabilities for toxicology and pathology data management. Pristima® VM delivers extensive capabilities for vivarium management and veterinary care. This unique solution delivers key features that effectively bridge the gap between the business, animal management and scientific aspects of research which are absent in many of today’s preclinical solutions. Pristima VM’s rich graphical user interface, detailed reports and visualizations deliver the most comprehensive animal facility solution.

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