SOLICITATION NOTICE
A -- Tools for QT Data Management and Risk Assessment
- Notice Date
- 9/13/2004
- Notice Type
- Solicitation Notice
- NAICS
- 541690
— Other Scientific and Technical Consulting 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, MD, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- D8401904
- Response Due
- 9/23/2004
- Archive Date
- 10/8/2004
- Description
- The Food and Drug Administration intends to award a Purchase Order on a sole source basis to Mrs. Sarah Marston for research services for the project: Tools for QT Data Management and Risk Assessment. This project is a continuation of a project piloted under CDER?s intramural RSR grant program. The RSR project aims to create a centralized, user-friendly, all-accessible QT data management database along with a jumpstart tool for standardized, reference QT risk assessment approaches as recommended in the Concept Paper. This set of standardized data archiving and analysis tools may promote efficient, accurate, and consistent QT study review and communication risk. The ability to compare QT response and variability in QT response to treatment and controls within and across drug classes may enhance science-based regulatory decision-making. It may provide valuable information aiding in study design recommendations. This extension of the RSR project to be performed by this contractor specifically aims to build on the methodology created to date. The Contractor will be hired to make the pilot product ready for distribution to and use by the reviewers at the FDA. Additionally, the intern will perform data analyses to answer important questions in the field. The contractor should be able to complete the following tasks: 1. Improve the existing product (product = data warehouse and automated data analysis methods. 2. Optimize the efficiency of existing data analysis routines 3. Improve upon graphical displays of results 4. Optimize product performance with regard to its interface between Splus and the database 5. Develop methodology for archiving results 6. Develop methodology for performing cross study comparisons 7. Develop methodology for displaying the results of a cross-study comparison 8. Evaluate trends in response to treatment and controls and in baseline response 9. Perform clinical trial simulation to evaluate different study designs 10. Evaluate the relative contribution of predictors of response The contractor shall obtain FDA security clearance prior to beginning work. Contractor shall sign confidentiality agreement prior to beginning work under this contract. An award will be made in ten (10) days from the date of this notice. This is not a request for quotes; however, sources may submit descriptive literature, which fully demonstrate their capabilities, which will be considered by the agency; and also have the following qualifications: a. Possess an advanced degree in statistics, pharmaceutical science or another relevant field, b. five years of experience in data analysis, c. experience in Splus programming and, d. ability to work independently and in team settings. This sole source procurement is being awarded as a simplified acquisition in accordance with FAR Subpart 13.5.
- Place of Performance
- Address: DHHS/FDA/CDER, 5600 FISHERS LANE, ROCKVILLE, MD
- Zip Code: 20857
- Country: USA
- Zip Code: 20857
- Record
- SN00670968-W 20040915/040913211707 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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