FY26 Annual Send Explorer Warehouse and Technical Support

VERSION HISTORY VersionNumber Implemented By Revision Date Approved By Approval Date Description ofChange 1.0 Xiaojun Jie 05/29/2020 2.0 Karen Zeiter 06/01/2020 3.0 Divine Agbale 04/16/2021 4.0 Divine Agbale 04/12/2022 5.0 Jing Kang 03/06/2023 6.0 Jing Kang 01/25/2024 7.0 Jing Kang 02/05/2025 8.0 Jing Kang 01/27/2026 FY26 Annual Send Explorer Warehouse and Technical Support, or an equal to solution 1. General 1.1 Background The Center for Drug Evaluation and Research (CDER) of the U.S. Food And Drug Administration (FDA) requires software to support the nonclinical review of CDISC- SEND submissions. The Office of Computational Sciences (OCS) has purchased and deployed SEND Explorer Warehouse in order to fully support CDER’s Office of New Drugs (OND) with regulatory review. 1.2 Scope The contract shall provide OCS with a Send Explorer Warehouse license on Development Environment, Test Environment, Production, and Pre-production, or equal to software solution with technical support. 2 Description of Work 2.1 The Send Explorer Warehouse, or equal to software solution, shall have the following salient and software update characteristics: 2.1.1 Salient characteristics: 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 thumbnail plots to display distribution of subject data across groups Line graphs to visualize patterns of group means and individual subject data over time Clinical observations time course to reveal 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 of pathology findings 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 Single-study survival plot to plot survival in long-term studies Correlations matrix to reveal pairwise correlations of endpoints for selected subjects, identifying those with histopathology findings in tissues of interest Multi-study scatterplot time course to compare dose-response and time course relationships in a selected endpoint for a group of related studies with the ability to overlay historical control reference range values Multi-study histopathology bar chart to visualize prevalence and severity of histopathology findings across studies or in untreated control subjects Historical control distribution to reveal the distribution of numeric data in control subjects across studies, stratified by selected fields of interest Multi-study line graph to compare study-specific time course patterns in group means and individual subject data for one or more selected endpoints across studies Supports a variety of source data formats including direct connection to data collection systems Handles custom domains and provides term reconciliation functionality Override records and create and populate ad hoc study metadata fields for querying data and filtering visualizations 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 Excel Pivoting of data by time-point, test code, and/or subject Group summary and incidence calculations based on a user-specified group definition Scientifically-relevant data visualizations including scatterplots of subject data, group mean bar charts, and Severity Heatmaps™ Reference range highlighting and calculated % change from control group mean Hyperlink to comments and supplemental qualifiers Hyperlink to multi-domain subject view with tabular and graphical displays of data Multi-study Correlations Matrix visualization with tissue-finding indicators and drill-down to subject data Multi-study Timecourse Grid visualization permitting comparison of endpoint across studies and over time Straight-forward load interface and study dashboard Bulk studies loading to watchfolder from the front end Fully-compliant SEND-based data model Multi-study/multi-domain data query grid Hyperlinked related records Ability to integrate data by easily registering new source systems and connectors regardless of how the data was collected Ability to view and interact with data visualizations before data is converted into SEND, allowing for quick response to questions during or after a study from internal departmental teams or regulators Administrative tool to allow term reconciliation, to view/modify mapped terms, to specify unit transformations, and to identify number of decimal places for display Ability to load, reload, or delete individual domains or an entire study 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 Bulk load studies from Dashboard to Watchfolder Ability to flag dosing timepoints in line graph Support hierarchical x-axis in multi-study visualizations Add numeric endpoints from BW, OM PP, and VS domains to Scatterplot Timecourse View Include %Change from Baseline in selected multi-study visualizations 2.1.2 Software update characteristics: All software new version release during the contract performance period. All software version must be compatible with FDA’s existing SEND Explorer database. All software bug fix patches during the contract performance period. All usual manual updates due to the software upgrade during the contract performance period. All Deployment and installation documents due to the software upgrade during the contract performance period. Refresh of technology to Oracle 19c Enterprise Edition, .NET v10, and D3v6 Poi…