INDS Logo   Integrated Nonclinical Development Solutions, Inc.
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Single Study Visualizations

Summary View for Numeric Data

…to visualize patterns and trends in numeric data with summary statistics, scatterplot, out of concurrent control range indicator, and % control mean calculations

Summary View Detail

…to review thumbnail visualizations or display detailed view showing distribution of subject data across groups

Line Graph

…to visualize patterns of numeric data over time

Clinical Observations Timecourse

...to identify dose-related patterns and trends in clinical observations over the course of a study

Severity Heatmap

…to visualize patterns and trends in both incidence and severity

Cross-Domain Subject View

…to put a subject's data into perspective as compared to its own group and control group, on a single day or over time

 

Send Explorer Plus Logo

Multi-Study Visualizations

Correlations Matrix

…to reveal pairwise correlations of endpoints for selected subjects, identifying those with histopathology findings in tissues of interest.

Multi-Study Timecourse Grid

…to compare the timecourse pattern of selected endpoint(s) across studies of interest.

Multi-Study Histopathology Barchart

…to visualize relative prevalence of histopathology findings across studies.

Historical Control Distribution

…to reveal the distribution of selected control data across studies, stratified by fields of interest.

 

Integrated Nonclinical Development Solutions, Inc. (INDS, Inc.) is pleased to announce the release of SEND Explorer® Product Family v7.0, 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.  

New features for the v7.0 release include the following:

  • Multi-Endpoint Line Graph now provides option to produce subplots by subject in addition to treatment, dose, or sex.

  • Visualization of %change from baseline values in Summary View and Multi-Endpoint Line Graph, where baseline is identified.

  • Support of Cross-Over study design - multi-endpoint line graph, summary view, and cross-over scatter visualizations.

  • User-requested enhancement to Exposure Plot to plot actual dose level vs exposure

  • Update all Histopathology visualizations to accommodate modified standard SEND terms for severity

  • Interface for updating configuration settings

  • Mouse-over any excluded value (identified with greyed-out text) to display reason for exclusion (if it exists)

  • Ability to create, save, and apply User Presets and Shared Presets.

  • Ability to summarize and plot % change from baseline for any endpoint where the baseline value has been flagged in SEND

  • Ability to embolden or suppress one or more lines in Multi-Endpoint Line Graph: lines associate with either group means or individual subject values

  • Client-suggested usability improvements

  • Ability to filter Summary View for endpoints meeting criteria of interest

  • Ability to navigate to a different subject in Subject View by clicking on a plotted point in any visualization thumbnail

  • Ability to collapse single-study histopathology findings across all severities, to sort subjects by disposition day, or filter for tissues of interest

  • Ability automatically load data saved to a designated Watch Folder location

  • Ability to load non-SEND data as a primary or secondary source via spreadsheet

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. The database version 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, perform advanced term reconciliation functionality, and refresh internal data sources on a schedule.

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 and open in Excel

  • Ability to pivot data by timepoint, test code, and/or subject

  • Group summary and incidence calculations based on user-specified group definition

  • Option to configure application to perform Dunnett’s t-test for pairwise comparison to concurrent controls

  • Scientifically-relevant data visualizations including scatterplots of subject data, group mean bar charts, Multi-Endpoint Line Graph@* with optional error bars (now supporting cross-over study design*), Clinical Observations Timecourse visualization, Exposure Plot@*, Schedule View, cross-domain Subject View@*, Severity Heatmaps™@*, and Cross-Over Scatter*

  • Reference range highlighting and calculated %change from control group mean

  • Ability to filter for endpoints based on statistical flags or out-of-control-range criteria*

  • Hyperlink to comments and supplemental qualifiers

  • Hyperlink to multi-domain Subject View with tabular and graphical displays of data

  • The ability to create and save report and visualization presets so they can be recalled and subsequently applied to the same or similar study using the same computer/browser

  • Admin interface to system configuration file to facilitate configuration changes*

  • Ability to customize Toxicity Profiles, update system options, add organizational branding

* New to v7.0; @ User-requested enhancements included inv7.0

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

  • 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 for sharing with others in your organization

  • Ability for user to capture and retain endpoints/tissues of interest while reviewing summary data

  • Ability to apply 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

  • Multi-study Correlations Matrix visualization with tissue-finding indicators and drill-down to subject data

  • Multi-study Timecourse Grid visualization permitting comparison of selected endpoint across studies and over time

  • Multi-Study Histopathology Barchart@* to facilitate recognition and communication of patterns in histopathology findings, including incidence in historical controls

  • 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, subject age, etc.

  • The ability to create and save user-specific and shared report/visualization presets so they can be recalled and subsequently applied to the same or another study using any computer/browser*

* New to v7.0; @ User-requested enhancements included in v7.0

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 load, reload, or delete individual domains or an entire study

  • Ability to load non-SEND data via generic spreadsheet loader for primary sources

  • Ability to load non-SEND data via generic spreadsheet loader for secondary sources*

  • 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

  • Ability to create source-specific Watch Folders for autoloading files posted to the folders

* New to v7.0

Products in the SEND Explorer® Product Family v7.0 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.