Savante

A Comprehensive Data Warehouse,
Analytics and SEND Management System

Overview

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® preclinical software suite, 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.

How Savante works

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.

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

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

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 & visualization

Flexible data analysis & 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

Pristima SEND Submission Management

The Pristima Savante SEND component is fully integrated with the full Pristima Data Management Suite 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 application suites and a friendly user interface that provides the user with guides and queues to complete the submission.

 Our New

SEND Intelligence Services

  • SEND guidance for the collection of the preclinical study data
  • Secure data transmission between Xybion and its clients
  • Automated transformation of client’s raw data files and import into Savante along with creation of the trial design
  • Automated production of the SEND v3.1 data set including the data domains, Define-XML and Study Data Reviewer’s Guide
  • Internal review of SEND data sets and quality assurance of SEND compliance

Xybion's SEND Submission Software enables Life Sciences organizations to prepare SEND-compliant data sets ready for FDA submission

© Xybion Corporation 2020