Integrated Nonclinical Development Solutions, Inc. (INDS, Inc.) is pleased to announce the release of SEND Explorer^® Product Family v9.0, a validated, web-based application designed by scientists to provide advanced viewing, data summarization, and visualization capabilities for study data produced in SEND (Standard for Exchange of Nonclinical Data) 3.0 format or SEND 3.1 format. SEND Explorer Products allow organizations to leverage their investment in creating SEND datasets for regulatory submissions by making study data accessible to scientists for decision-making.

 

 

New features for the v9.0 release include the following:

Single-Study Enhancements

• Provide new navigation options in standard grid and summary views
• Ability to plot upper and lower reference range values as provided in SEND dataset on Summary by Timepoint thumbnail scatterplots
• Additional plot by fields and summary measure (Geometric Mean)
• User-requested enhancements in Subject View
• Allow users to flag endpoints and/or tissues of interest within Subject View
• Enable Severity Heatmap to filter by Toxicity Profile
• Provide tabular Summary View for Severity Heatmap, showing group totals and suppressing findings for individual subjects
• Ability to export most single-study visualizations in high-quality SVG or PNG format
• Support for IS domain (standard grid and summary view)
• Support for Custom domains (WH only)
• Option to display data from most domains in CTD format
• Option to save data in XPT/CSV/XLS format

Multi-Study Enhancements

• Provide advanced (Boolean) querying functionality in Multi-Study Grid for Super Users, Data Stewards, and Administrators
• Support numerous additional filter fields in Multi-Study Visualizations
• Re-engineer Correlations Matrix to improve performance and add functionality (including best fit lines)
• Select box plot, mean + stddev, or mean + stderr in Scatterplot Timecourse, Clin Path vs Histo Severity or Exposure vs Histo Severity plots
• Provide Align by Dose in Scatterplot Timecourse, Clin Path vs Histo Severity, and Exposure vs Histo Severity plots
• Ability to export multi-study visualizations in high-quality SVG or PNG format
• Enhanced single- and multi-study logging features and ability to add custom admin reports to Admin dashboard
• Performance improvements for multi-study grid and multi-study visualizations

Study Loading Improvements

• Only newly uploaded or changed finding records are processed to minimize load time
• User-requested study loading efficiency improvements, including the ability to add/remove studies from the load queue via the Dashboard

SEND Explorer provides single-study functionality including the ability to review and query SEND data; generate scientifically-relevant visualizations to identify trends and patterns within a study; and review all data for a single subject to compare vs other subjects in its group or vs control subjects to identify patterns across endpoints of interest, at a given timepoint and over time.

SEND Explorer Plus additionally includes a SEND-optimized database to extend SEND Explorer functionality to the multi-study environment and provides powerful yet intuitive cross-study querying capabilities and multi-study visualizations. SEND Explorer Plus also allows users to save and reapply settings to the same or different studies, to display % change from baseline values, and identify and filter for endpoints of interest.

SEND Explorer Warehouse provides the same visualization capabilities as SEND Explorer Plus and additionally includes a data warehouse infrastructure which enables organizations to combine legacy/non-SEND data sources with their SEND data, connect to non-SEND data sources, support for custom domains, advanced term reconciliation functionality, and refresh internal data sources on a schedule.

SEND Explorer Gold provides all of the functionality of SEND Explorer Warehouse except for the ability to support custom domains, reconcile terms, override data, or match subject numbers across sources. As with SEND Explorer Warehouse, the data it consumes does not need to be in SEND format so this product is a good fit for organizations who want a direct connection to a data collection system, non-SEND interim data, or a legacy format without the need for cross-study reconciliation of terms.

SEND Explorer V9.0 Functionality, by Product

SEND Explorer features include:

• A robust data grid that merges subject and group metadata with associated results
• Advanced data management and query features such as column hiding/showing, sorting, and filtering
• Ability to export all or filtered data to CSV or Excel
• Ability to pivot data by timepoint, test code, and/or subject
• Ability to produce group summary and incidence calculations based on user-specified group definition with data pivoted by Timepoint, Test Code, or Group
• Ability to configure application to perform Dunnett’s t-test for pairwise comparison to concurrent controls
• Ability to display group summary measures CV, Std Err, Geometric Mean*, Fold Control, and/or % Change from Control, in addition to the default summary measures N, Mean, and Std Dev
• Ability to display reference range highlighting
• Scientifically-relevant data visualizations including scatterplots of subject data, group mean bar charts, Multi-Endpoint Line Graph with optional error bars (also supporting cross-over study design), Clinical Observations Timecourse visualization, Exposure Plot, Schedule View, cross-domain Subject View^@, Severity Heatmaps™^@, and Cross-Over Scatter plot
• Ability to filter for endpoints based on statistical flags or out-of-control-range criteria
• Ability to produce tabular MA/MI summary display* and filter by Toxicity Profile*
• Ability to produce high-quality (SVG or PNG) image exports for single-study visualizations*
• Hyperlink to comments and supplemental qualifiers
• Hyperlink to multi-domain Subject View with tabular and graphical displays of data
• Admin interface to manage users, access/update system configuration file, and review admin reports*
• Ability to customize Toxicity Profiles, update system options, add organizational branding

*New to v9.0; ^@User-requested enhancements included in v9.0

SEND Explorer Plus includes all of the single-study features above as well as:

• Straight-forward load interface and study dashboard for filtering studies based on selected study metadata criteria
• Only newly uploaded or changed finding records are processed to minimize load time*
• Fully-compliant SEND-based data model
• Study Overview Page containing a free-text field for capturing scientific observations and notes, displaying uploaded image files, providing hyperlinks to other documents or web-pages of interest, and including a list of endpoints of interest
• Display of data-driven Trial Design Summary Table on Overview Page (paralleling that included in nSDRG)
• Display of data-driven Dataset Summary on Overview Page (paralleling that included in nSDRG)
• Ability for user to capture and retain endpoints/tissues of interest while reviewing individual subject data* or group summary data
• Ability to include ad hoc endpoints of interest en masse to selected visualizations
• Ability to display, summarize, and plot % change from baseline measures in single-domain view, Summary View^@, and Multi-Endpoint Line Graph^@
• Ability to filter Summary View, Multi-Endpoint Line Graph, Subject View, and Severity Heatmaps™ for endpoints/tissues of interest
• Multi-study/multi-domain data grid^@ for querying across domains and studies with permissions-based advanced (Boolean) querying functionality*
• Single/Multi-Study Correlations Matrix^@ visualization with tissue-finding indicators and drill-down to subject data
• Single/Multi-Study Scatterplot Timecourse^@ visualization permitting comparison of a selected endpoint across studies and over time
• Single/Multi-Study Histopathology Barchart to facilitate recognition and communication of patterns in histopathology findings, including incidence in historical controls
• Single/Multi-Study Subject Compare chart providing side-by-side comparison of subject findings from within or across studies
• Multi-Study Historical Control Values Distribution visualization, revealing the distribution of numeric endpoints in control subjects, differentiable by sex, species, vehicle, test facility, supplier, age, etc.
• Single/Multi-Study Clin Path vs Histo Severity Plot^@ providing a mechanism to plot subject values for a selected Clin Path endpoint vs the histopathology findings in the same subjects, within or across studies
• Single/Multi-Study Exposure vs Histo Severity Plot^@ providing a mechanism to plot subject values for a selected Exposure endpoint vs the histopathology findings in the same subjects, within or across studies
• Ability to display boxplot or Mean + Std Err* or Mean + Std Dev* in Scatterplot Timecourse, Clin Path vs Histo Severity, and Exposure vs Histo Severity plots
• Ability to produce high-quality (SVG or PNG) image exports for single- and multi-study visualizations*
• Ability to create and save user-specific and shared data grids, summary tables, or data visualization presets so they can be recalled and subsequently applied to the same or another study using any computer/browser
• Option to display data from most domains in CTD format
• Option to save data in XPT/CSV/XLS format*

*New to v9.0; ^@User-requested enhancements included in v9.0

SEND Explorer Gold includes all of the above features in SEND Explorer Plus as well as:

• Ability to specify SEND or non-SEND data source on upload of data file
• Ability to load/reload data directly from data collection system^@
• Ability to load, reload, or delete individual domains or an entire study
• Ability to add/remove studies from the load queue via the Dashboard*
• Ability to load non-SEND data via generic spreadsheet loader for primary sources (including Repro EFD data and IS domain*)
• Ability to load non-SEND data via generic spreadsheet loader for secondary sources (including Repro EFD data and IS domain*)
• Ability to review load history and load history details to help identify and correct data errors
• Ability to load data on-demand or according to a specified schedule, including only on weekdays*
• Ability to create source-specific Watch Folders for autoloading files posted to the folders

* New to v9.0; ^@User-requested enhancements included in v9.0

SEND Explorer Warehouse includes all of the above features as well as:

• Web-based administrative interface for term reconciliation, to view/modify mapped terms, and to specify unit transformations
• Ability to register new source systems and connectors to integrate legacy data
• Ability to register and visualize data from custom domains* (standard grid and summary view)
• Ability to load non-SEND data for custom domains via generic spreadsheet loader for primary sources*
• Ability to load non-SEND data for custom domains via generic spreadsheet loader for secondary sources*
• Ability to supply data overrides^@, with audit log
• Ability to align study subject numbers from two different sources that don’t use the same subject numbers for the same subjects

* New to v9.0; ^@User-requested enhancements included in v9.0

See SEND Explorer Product Family v9.0 Release Notes for the complete set of requirements and bug fixes included in v9.0 as well as a cumulative listing of usage notes and system/browser limitations.

Products in the SEND Explorer^® Product Family v9.0 are now available for purchase. INDS has partnered with Instem for global sales and support services. Please contact INDS at sendexperts@inds-inc.com or Instem at submit@instem.com for more information on any of these tools or to request a demo.