A -- Clinical Trials Resource Center (CTRC)

The National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, is seeking proposals for the creation of a national resource center dedicated to research and development of new theories and methodologies for clinical trials in rheumatic diseases. The contract will support one Clinical Trials Resource Center. The goal of the Clinical Trials Resource Center (CTRC) is to conduct research on the development, application and evaluation of new clinical trial theories and technologies for the evaluation of safety, efficacy and effectiveness of therapies for rheumatic diseases. The CTRC will also be charged with the translation of new knowledge about disease pathogenesis and natural history, responses to treatment and other outcomes into new clinical trial designs. In addition, the CTRC will be responsible for the application of new technologies for clinical trial design and implementation. The ultimate goal of these activities is the development of more informative, scientifically rigorous, standardized and cost effective designs for clinical trials in rheumatic diseases. Another goal of this initiative is to provide an environment for the open and unbiased evaluation of current approaches to clinical trials in rheumatic diseases. The CTRC will function as a catalyst for the identification of areas of need and opportunity by experts from academia, the private sector, patient advocacy organizations and agencies of the federal government. It is anticipated that the CTRC will establish collaborations and partnerships with academia, as well as biotechnology and pharmaceuticals companies. It is anticipated that one cost reimbursement, level of effort type, contract award will be made for a period of 5 years beginning on or about September 30, 2003. The annual level of effort anticipated to be expended is 8.35 full time equivalents. The solicitation, NIH-NIAMS-03-03, will be available electronically on or about 15 days from the date of this notice and may be accessed through the Internet at the following address: http://www.niams.nih.gov/rtac/funding/grants/rfp/wwwrfp.htm or http://www.eps.gov/. Proposals will be due on or about March 27, 2003. Offerors are responsible for downloading their own copy of the solicitation and amendments and for routinely checking the Internet site for any possible solicitation amendments that may be issued by the Government. This is not a Small Business Set-Aside. All responsible sources may submit proposals which will be considered by the Government. The North American Industrial Classification System (NAICS) code for this acquisition is 541710. This advertisement does not commit the Government to award a contract.