Inactive Total Small Business Set-Aside (FAR 19.5)

SEND Explorer Plus Upgrades - Warehouse Licenses and Annual Maintenance Brand Name or Equal (For full description of the requirement, review the attached solicitation) This is a combined/synopsis soli... SEND Explorer Plus Upgrades - Warehouse Licenses and Annual Maintenance Brand Name or Equal (For full description of the requirement, review the attached solicitation) This is a combined/synopsis solicitation issued under FAR Part 12 and 13.5 procedures. This is an unrestricted procurement. The NAICS code is 541910. The Government is in no way obligated to make an award, nor to pay any costs incurred by the Contractor in preparing and submitting its quote BACKGROUND The Office of Biostatistics and Epidemiology HIVE group (OBE/HIVE) supports review of CDISC-SEND standardized submissions for FDA nonclinical review with SEND Explorer. SEND Explorer is user-friendly, web-based software that is specifically designed to load and display CDISC-SEND formatted datasets without manipulation. Send Explorer Warehouse provides tabular views and summary views for numeric SEND domains including summary statistics, scatterplots for each time point, a visual indication of data points that are different from controls, and % of control calculations. Additionally it provides severity heat maps for MA, MI, and TF Domains. A single animal detail view which can be accessed from tabular views by hyperlink shows results from multiple user-selected study endpoints across domains for the selected animal and provides scatter plots to compare findings for the selected animal to others in the study. Multiple studies can be combined into visualizations, including a correlations matrix for comparing numeric findings, scatter plots to compare an endpoint between studies across a time course, and a visualization to identify patterns in histopathology findings across studies. The SEND Explorer Warehouse upgrade provides the ability to address sponsor specific differences between studies, reload updated studies, maintain and review load history, and load data on-demand from Watch Folders to automate data loading upon receipt to FDA. The software is approved for use on the FDA Network. Project Objectives The FDA CBER Office of Biostatistics and Epidemiology is seeking SEND Explorer Plus upgrades to SEND Explorer Warehouse. 3.0 Scope of Work Brand Name or Equal Requirements: Salient Characteristics and Specifications for the Servers and Switches Configuration: If proposing an alternate solution, the Contractor shall ensure that the proposed solution meets the following salient characteristics. Compatibility: The software licenses the contractor provides: shall have a web-based user interface and support deployment on a cloud computing cluster shall support multiple concurrent users shall work in IE 11, Chrome 50 or later, and Firefox 44 or later shall load CDISC-SEND datasets that are compliant with SENDIG v3.0 shall provide tabular views and summary views for numeric SEND domains to include summary statistics scatterplots for each time point a visual indication of data points that are different from control percentage of control calculations shall provide a severity heatmap for MA, MI, and TF domains shall support hiding columns, sorting, and filtering in tabular view shall export data to Excel shall provide support for comments, supplemental qualifiers, and related records shall provide single animal detail view which can be accessed from tabular views by hyperlink that show results from multiple user-selected study endpoints across domains for the selected animal, and provide scatter plots to compare findings for the selected animal to others in the study shall provide a way to combine multiple studies into visualizations, including a correlations matrix for comparing numeric findings, scatter plots to compare an endpoint between studies across a time course, and a visualization to identify patterns in histopathology findings across studies