AWARD
D -- DataFit Support Services
- Notice Date
- 9/15/2015
- Notice Type
- Award Notice
- NAICS
- 518210
— Data Processing, Hosting, and Related Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SSS-FY15-1145136
- Archive Date
- 9/30/2015
- Point of Contact
- Steven Chang, Phone: 240-402-7527
- E-Mail Address
-
Tzeleong.Chang@fda.hhs.gov
(Tzeleong.Chang@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Award Number
- HHSF223201510037I
- Award Date
- 9/15/2015
- Awardee
- Pinnacle 21, LLC, 531 Playmouth Rd, STE 508, Plymouth Meeting, Pennsylvania 19462-1642, United States
- Award Amount
- 5000000
- Description
- 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/Awards/HHSF223201510037I.html)
- Record
- SN03886261-W 20150917/150915235633-9869ac01990f4471aec52cfd2441675f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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