SOURCES SOUGHT
D -- FDA Regulatory Review Support - FDA-SOL-1100474
- Notice Date
- 4/13/2012
- Notice Type
- Sources Sought
- NAICS
- 541519
— Other Computer Related Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SOL-1100474
- Archive Date
- 5/15/2012
- Point of Contact
- Veronica Dhaness, Phone: 3018279386, Jennifer Fagan, Phone: 3014435861
- E-Mail Address
-
Veronica.Dhaness@fda.hhs.gov, jennifer.fagan@fda.hhs.gov
(Veronica.Dhaness@fda.hhs.gov, jennifer.fagan@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Request For Information (RFI) Key Technologies Matrix Attachment 7 Attachment 6 Attachment 5 Attachment 4 Attachment 3 Attachment 2 Attachment 1 FDA Regulatory Review SOW The scope of this requirement is to provide the complete range of activities necessary to promote the efficient and technologically advanced review and analysis of standardized data for regulatory review of sponsor submissions at the FDA. The contract will enable reviewers to assess product safety, efficacy, and quality by providing the capability to ask sponsors more in-depth questions, devote more time to team discussions, and achieve greater transparency and consistency in decision making and documentation. These capabilities shall be enabled through coordinated use of technologies across all review disciplines, as well as organizational initiatives (e.g. change management, communications, training, knowledge management, and collaboration). The contractor shall support the implementation of data standards and use of analytics and tools. Data standards are critical to provide a common language foundation for approaching analysis of sponsor submitted clinical data.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-1100474/listing.html)
- Record
- SN02721667-W 20120415/120413234810-772dd229a62adde3b4a766eac420ca16 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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