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.
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.
Integrated solution with Spotfire makes nonclinical study data from in-house studies or partners accessible for cross-study analysis and visualization.
Ability to ingest study data from disparate sources and formats to create SEND compliant datasets.
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 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.
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.
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).
105 College Road East
Princeton, New Jersey 08540
105 College Road East
Princeton, New Jersey 08540
Head of Quality Assurance
Heidi leads Xybion’s Quality Assurance practice. She has over 20 years’ experience in designing and implementing quality assurance policies. Since joining Xybion in 2000, Heidi worked with several clients to design quality policies and ensure compliance. She is responsible to hosting Xybion customer audits. Heidi has a BA degree in Biology from The King’s College.
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