Savante

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.

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.

The CDISC 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

The Pristima Suite 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 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.

The Pristima® Suite 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.

SEND Intelligence Services

SEND Intelligence Services enable companies to automate the transformation of raw data files of preclinical research and the production of SEND v3.1 data sets without any need for the acquisition of a new system or increased staffing. Xybion’s Savante is one of the first on the market to achieve full compliance with SEND IG v3.1 with a validated solution.

SEND is a standard for the collection and formatting of nonclinical data so that it may be included in preclinical data submission to the FDA and other regulatory bodies that adopt the standard. By standardizing the format in which the data is submitted, SEND naturally impacts the data collection and aggregation by harmonizing the study designs and normalizing the terminologies used by scientists today. This homogenization of the preclinical data facilitates and leads to efficiencies on the part of the reviewers, accelerating the regulatory review process for NDA, ANDA, IND, and certain BLA submissions.

Importantly, with the standardization of data formats and the normalization of the terminologies used in the data set, the SEND standard also provides a long-sought transport mechanism by which CROs may transmit data to their Pharmaceutical clients for purposes other than submissions, such as data analyses and data mining.

Collect, Aggregate, and Analyze Nonclinical Data for SEND IG v3.1

All organizations now conducting or contracting preclinical studies with the intention to submit to the FDA must require the final results of each study to adhere to SEND standards. Xybion’s user community including top Pharma and CRO organizations across the world have participated in the design and have become accustomed to the most automated SEND datas et production process provided by Savante. Xybion’s Savante is one of the first on the market to achieve full compliance with SEND IG v3.1.

Xybion has developed a rich tool set and has a wealth of SEND data set experience through the development of its Savante module. Unlike some companies with individual tools addressing a specific aspect of the SEND preparation process, Xybion’s Savante solution provides a single package that allows the user to define the trial design, import data from a variety of sources, and produce the complete SEND data set, Define-XML, and Study Data Reviewer’s Guide all at once. Upon creation of the SEND products, these files may be automatically ingested into the Savante document management system and placed immediately under version control.

Data Preparation Services

Many organizations do not employ data management systems capable of producing the SEND dataset nor maintain SEND expertise within their scientific data staff. In many cases, the volume of studies conducted by a lab may not justify the cost associated with the acquisition of a new systems or increased staffing; this is where Xybion’s SEND services come in.

Utilizing the same Savante system already in production at our client sites, Xybion can securely receive the client raw data, ingest the data into Savante and automatically produce the Define-XML, data set, and Study Data Reviewer’s Guide – then securely return the complete package to the client. Our information systems, toxicology, and regulatory experts can guide the client’s staff in terms of the format of the raw data, the study design implications, and the terminology to use when collecting data.

Savante also empowers our SEND experts to adjust to the varying data sources and terminologies that may have already been utilized, and to transform the data to be SEND compliant. Xybion’s staff utilizes a validated environment in the production of the SEND data set so each client is assured of the quality of the SEND data set.

Salient Features of SEND Intelligence Services

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

Can SEND Intelligent Services Support any Preclinical System?

Xybion provides the industry-best intelligent services to all clients, irrespective of the data management tool they use and the SEND data set services to their CROs, who do not provide SEND Compliant submission data sets. Additionally, they can help produce both SEND IG v3.0 for ongoing studies and v3.1-compliant data sets for studies that run in any preclinical system.