DHHS/PHS/FDA/Office of Contracts and Grants Management, Contracts Operations Branch, HFA-512, 5600 Fishers Lane, Park Bldg., Rm 3-32, Rockville, Maryland 20857

B -- BIORESEARCH MONITORING SOL FDA 243830-95 DUE 071295 POC Twanda Shackelford, Contract Specialist, (301) 443-0424, Deborah Striegel, Contracting Officer, (301) 443-0424, FAX (301) 443-4420 Proper monitoring of clinical investigations to assure adequate protection of the rights of human subjects and the safety of all subjects involved in clinical investigations as well as the quality and integrity of the resulting data submitted to the FDA is a requirement of research sponsors under 21 CFR Parts 312 (Human Drugs and Biologics), 511 (Animal Drug Use), 812 & 813 (Medical Devices). To ensure appropriate procedures and quality control, the Food and Drug Administration (FDA) requires contract services to conduct an audit of the records of designated study sites to determine if the investigator has followed the protocol and applicable regulations and to verify the accuracy and completeness of the study data. This will be accomplished by inspection of the sites physical facilities and procedures together with a review of individual subject records (source documents) and the study case report forms (CRFs) prepared by the investigator(s). The Contractor will assure that the facility is in compliance with all current FDA Office of Compliance standards. Any deficiencies will be noted and itemized in the site visit report. Firms responding to this request should indicate whether they are or are not, certified by the Small Business Administration as an 8(a) firm. This information will be used to determine if a buy for 8(a) firms, or a set-aside for small business firms, is appropriate. The applicable SIC Code is 8748 with a size code standard of $5 million. A fixed price type contract is contemplated for a one year performance period. Requests for copy of RFQ must be received no later than 10 days after publication of this notice. (0158)

Loren Data Corp. http://www.ld.com (SYN# 0011 19950608\B-0002.SOL)