SOLICITATION NOTICE
A -- Statistical Design, Monitoring and Coordination of Vision Clinical Trials and Epidemiology Research
- Notice Date
- 2/22/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Division of Research Acquisition, 6100 Executive Boulevard, Room 6E01, MSC 7540, Bethesda, MD, 20892-7540
- ZIP Code
- 20892-7540
- Solicitation Number
- 260-06-04
- Point of Contact
- Silver Jones, Contracting Officer, Phone 301-496-4487, Fax 301-402-0178,
- E-Mail Address
-
sj12Z@nih.gov
- Small Business Set-Aside
- Total Small Business
- Description
- The National Eye Institute (NEI), National Institutes of Health (NIH) has a requirement for the Statistical Design, Monitoring and Coordination of Vision Clinical Trials and Epidemiology Research. The Contractor shall assist in the development, design, interpretation, and evaluation of clinical trials, epidemiologic and natural history studies, and outcomes research involving eye diseases and visual disorders. The work under this contract shall include: 1) Development, preparation and revision of manuals of procedures, study forms, and procedures, training for NEI clinic staff in the collection and preparation of data and logistic support; 2) Data collection and storage, including reproduction and distribution of all study forms; receiving and storage of all data transmitted on the study forms or other media by the participating clinical centers, availability of a reading center that has the capability of reproducibly analyzing external and internal ophthalmic photographs and fluorescein angiograms, and assistance in the development and preparation of publicity materials for clinical trials to improve patient recruitment; 3) Study monitoring and communications, including training sessions for new clinical personnel, providing logistical support for NEI Data and Safety Monitoring Committee meetings, and monitoring adherence to all study protocols; 4) Data Management and maintenance, including the design of a computer data storage system that will receive, inventory, and store all information; 5) Data analysis, including detailed analyses of accumulated data to monitor studies for adverse and beneficial treatment effects; 6) Data reporting, including assistance in manuscript preparation; and 7) Provide support for preclinical requirements for the submission of Investigational New Drug requests (IND) to the FDA and other regulatory organizations. A five-year, cost reimbursement type contract is anticipated, with award to be made on or about June 30, 2006. RFP 260-06-04 will be available 15 days after the issuance of this synopsis and will be posted on this website. OFFERORS ARE RESPONSIBLE FOR ROUTINELY CHECKING THIS WEBSITE FOR ANY SOLICITATION AMENDMENTS THAT MAY BE ISSUED. NO INDIVIDUAL NOTIFICATION OF ANY AMENDMENTS WILL BE PROVIDED. Proposals will due 30 days after issuance of the solicitation. All responsible sources may submit a proposal which shall be considered by the Government. See numbered notes 1 and 26. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (22-FEB-2006); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.fbo.gov/spg/HHS/NIH/OLAO-DRA/260-06-04/listing.html)
- Record
- SN00992910-F 20060224/060222213717 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |