FDA/OCI FY26 Annual Send Explorer Warehouse and Technical Support, or an equal to solution

The FDA's Office of Computational Sciences (OCS) requires a contractor to provide a Send Explorer Warehouse license with technical support for the Development Environment, Test Environment, Production, and Pre-production. The contractor should provide software updates, bug fixes, and technical support. The contract includes deliverables such as an annual Send Explorer Warehouse license and technical support. The contractor must comply with FDA's information security and privacy requirements, including Section 508 standards and encryption. Key features of the Send Explorer Warehouse software include: • Summary view for numeric data • Summary view thumbnail plots • Line graphs • Clinical observations time course • Severity heatmap • Cross-domain subject view • Single-study survival plot • Correlations matrix • Multi-study scatterplot time course • Multi-study histopathology bar chart • Historical control distribution • Multi-study line graph • Support for various source data formats • Handling custom domains and term reconciliation functionality • Override records and ad hoc study metadata fields • Robust data grid • Advanced data management and query features • Ability to export data to Excel • Pivoting of data • Group summary and incidence calculations • Scientifically-relevant data visualizations • Reference range highlighting and calculated % change from control group mean • Hyperlink to comments and supplemental qualifiers • Hyperlink to multi-domain subject view • Multi-study Correlations Matrix visualization • Multi-study Timecourse Grid visualization • Straight-forward load interface and study dashboard • Bulk studies loading to watchfolder • 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 • Ability to view and interact with data visualizations before data is converted into SEND • Administrative tool for term reconciliation, unit transformations, and decimal places • Ability to load, reload, or delete individual domains or an entire study • Ability to review load history and load history details • 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 for hierarchical x-axis in multi-study visualizations • Addition of numeric endpoints from BW, OM PP, and VS domains to Scatterplot Timecourse View • Inclusion of %Change from Baseline in selected multi-study visualizations