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 Statistical Design, Monitoring and Coordination of Vision Clinical Trials and Epidemiology Research. This is a SOURCES SOUGHT NOTICE is to determine the availability of potential small businesses (e.g., 8(a), Veteran-owned Small Business, Service-disabled Veteran-owned Small Business, HUBZone Small Business, Small Disadvantaged Business, and Woman-owned Small Business) to assist in the development, design, interpretation, and evaluation of clinical trails, epidemiologic and natural history studies and outcomes research involving eye diseases and visual disorders. This requirement shall include: 1) Protocol Navigation to include design and development of clinical protocol, consent, and regulatory documents for all studies approved; 2) 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; 3) 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; 4) 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; 5) Data Management and maintenance, including the design of a computer data storage system that will receive, inventory, and store all information; 6) Data analysis, including detailed analyses of accumulated data to monitor studies for adverse and beneficial treatment effects; 7) Data reporting, including assistance in manuscript preparation; and 8) Provide support for preclinical requirements for the submission of Investigational New Drug requests (IND) to the FDA and other regulatory organizations. The Draft Statement of Work is posted herein. The anticipated Period of Performance is November 1, 2011 through October 31, 2016, for a period of five (05) years. THIS IS NOT A REQUEST FOR PROPOSALS and does not commit the Government to any contractual agreement. The contents of the capability statements shall be limited to fifteen (15) pages. Capability Statements exceeding the page limitation will not be considered. Four (4) copies of the capability statements must be submitted in writing to the address identified in this synopsis no later than Wednesday, January 26, 2011, 5:00 PM , EST. Interested sources should tailor their capability statements to be responsive to the tasks described above . Electronic capability statements will also be accepted and can be submitted via email to jonessi@mail.nih.gov Electronic capability statements are also subject to the fifteen (15) page limitation. Teaming arrangement are encouraged. The North American Classification System (NAICS) Code is 541712.