A -- Statistical Design, Monitoring and Coordination of Vision Clinical Trials and Epidemiology Research

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 NIH is seeking small business concerns, including 8(a) small business and/or small disadvantaged business, HUBZone small business and Service-Disabled Veteran small business concerns with the capabilities to 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. The NIH is requesting capability statements from small business concerns capable of fulfilling this requirement. The Technical Evaluation Criteria for this project is posted herein. THIS IS NOT A REQUEST FOR PROPOSALS (RFP) and does not commit the Government to award a contract now or in the future. No RFP is available at this time. Small business concerns that believe they possess the capabilities necessary to undertake the work described above should submit an original and two (02) copies of their capability statement, not to exceed 15 pages, to the address shown in this notice by February 3, 2006. Interested sources should tailor their capability statements to be responsive to the tasks described above and the evaluation criteria posted herein. Capability statements exceeding the page limitation will not be considered. Electronic copies of capability statements will also be accepted and can be submitted via email to contact@example.gov or faxed to Silver C. Jones @ +1 (555) 000-0000. Electronic capability statements are also subject to the 15 page limitation. The North American Classification System (NAICS) code is 541519. SEE NUMBERED NOTE 26. No collect calls will be accepted.