DataFit Support Services
Award Notice Posted
- Solicitation number
- FDA-SSS-FY15-1145136
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Awarded
- to Pinnacle 21, LLC
- Set-aside
- No set-aside
Opportunity facts
- Contract number
- HHSF223201510037I Federal IDV award
- NAICS code
- 518210 Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services
- PSC
- Not on record
Notice details come from SAM.gov. Updated .
Notice text
The DataFit program provides the FDA, specifically CDER, with a dashboard-driven, data standards checking platform. DataFit affords the ability to assess data quality and perform data validation for standards compliance of electronic clinical and non-clinical trial study submission data through a web interface for the selection of data based on the submission, set of studies, or standalone studies. DataFit validates submission data for compliance with the Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (SDTM) and Standard for Exchange of Nonclinical Data (SEND) standards. The system generates reports that display the conformance results and provide an overview of the quality of the submission data. DataFit enables reviewers to assess and understand the quality of incoming submission data at a summary level in hours, a process which would otherwise take a reviewer several days or weeks to accomplish during a manual review.
Files
| File | Type | Posted |
|---|---|---|
| Justification_and_Approval.pdf |
Notice history
| Notice | Type | Posted |
|---|---|---|
| This notice | Award Notice | |
| Operations, Maintenance and Enhancements of the DataFit Data Validation Tool | Award Notice |
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