NIH, NIAMS, Bldg. 45, Rm 5AS13A, 45 Center Drive, MSC 6500, Bethesda, MD 20892-6500

R -- DATA INTEGRITY ASSESSMENTS FOR NIAMS CLINICAL TRIALS SOL NIH-NIAMS-96-2 DUE 040196 POC Diana Lynn Wheeler, Contracting Officer, 301-594-2543. The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is seeking an organization to establish and implement a mechanism for assisting their awardees and scientists in establishing, following, and monitoring standards to preserve data quality and integrity in Institue supported clinical trials. The Contractor will be responsible for the development of guidelines for data quality and integrity assessments, as well as, standard operating procedures for the conduct of on-site data quality assessments at selected data coordinating centers and clinical sites. This activity will be directed primarily at Phase III clinical trials, although the NIAMS will consider all clinical trials appropriate for data quality assessment. It is estimated that the Contractor will be required to perform six on-site data integrity assessments per year. This acquisition will be a 100% Small Business Set-Aside. The Standard Industrial Classification Code (SIC) is 8741 - Management and Support Services for Research and Development, Size Standard - $3.5 million. Interested organizations should request either a streamlined or full Request for Proposal (RFP) package. If no selection is made, a streamlined version of the RFP will be provided, which includes only the Statement of Work, deliverable and reporting requirements, special requirements and mandatory qualifications, if any, and technical evaluation criteria. After examination of these documents, any organization interested in responding to this RFP must request the entire RFP in writing. Faxed requests will also be accepted. The fax number is (301) 480-4543. Since a limited number of copies will be printed, requests shall be filled on a first-come, first-served basis, until the supply is exhausted. The RFP will be issued on or about February 15, 1996, with proposals due on April 1, 1996. This advertisement does not commit the Government to award a contract. See Note 1. (0030)

Loren Data Corp. http://www.ld.com (SYN# 0093 19960131\R-0006.SOL)