Comprehensive Data Warehouse, Analytics, and SEND Management System

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SEND Creation and Data Warehouse solution for Life Sciences

Consolidating and validating data sets is a highly challenging and business-critical effort for many Contract Research Organizations (CROs) and drug developers who perform toxicology studies either internally or outsourced with external partners. Savante provides a mechanism for your organization to create, merge, validate, and visualize preclinical study data regardless of source or format.

Savante SEND submission software enables life sciences organizations to prepare SEND-compliant data sets ready for FDA submission.

Key Features

Savante streamlines the process of aggregating and consolidating nonclinical data coming from multiple sources, including internal studies and external partners. Additional features include:

SEND Standards

Data warehouse consolidates and formats study data based on SEND standards for easier reporting.
Savante creates SEND datasets based upon the SENDING standard and control terminology set date appropriate to your study start date.

Data Analysis & Visualization

Integrated solution with Spotfire makes nonclinical study data from in-house studies or partners accessible for cross-study analysis and visualization.

Data Aggregation

Ability to ingest study data from disparate sources and formats to create SEND compliant datasets.

Automated Data Collection

Synchronization from Pristima XD makes data collection from instruments seamless. Savante also accepts XPT formats from CROs or other systems & data can be augmented with data in CSV or Excel data files.

Savante In Action

Savante provides a vehicle for preclinical data aggregation, analysis, and visualization in SEND format to scientific staff and management.

Preclinical data from Pristima XD 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.

Data Analysis Capabilities using TIBCO Spotfire

Savante integrates with Spotfire to provide data visualization. This provides powerful, flexible access to all 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.

SEND Submission Resource Center

Savante as part of Xybion’s preclinical gold standard platform Pristima XD provides an automated solution for the creation and transport of SEND compliant datasets. The FDA has issued the final guidance on the Standard for Exchange of Nonclinical Data (SEND). Now, studies starting after Dec. 17, 2016, for applicable NDAs, BLAs, and ANDAs, and studies starting after Dec. 17, 2017, supporting IND submissions, must be submitted in accord with electronic standards specified by FDA (SEND for nonclinical).

SEND Intelligence Services

Xybion provides data preparation services to securely receive your raw data, ingest the data into our system and automatically produce the Define.xml dataset and a templated nonclinical study data reviewer’s guide. We complete the study data reviewer’s guide in collaboration with you and securely return the complete package.

Project Management Services

Computer System Validation

Software Development & Testing

Ready to learn more? Schedule a free consultation.

Comprehensive Data Warehouse, Analytics, and SEND Management System

SEND Creation and Data Warehouse solution for Life Sciences

Savante SEND submission software enables life sciences organizations to prepare SEND-compliant data sets ready for FDA submission.

Key Features

SEND Standards

Data Aggregation

Automated Data Collection

Savante In Action

Data Analysis Capabilities using TIBCO Spotfire

SEND Intelligence Services

Ready to learn more? Book a free demo.

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