DHHS, National Institute on Drug Abuse, Contracts Management Branch, OPRM, Parklawn Building, Room 10-49, 5600 Fishers Lane, Rockville, Maryland 20857

A -- CLINICAL OPERATIONS - CLINICAL TRIALS SOL N01DA-5-8050 DUE 051095 POC Point of Contact, Kenneth E. Goodling, Contract Specialist (301) 443-6677; Nancy A. Hurd, Contracting Officer The National Institute on Drug Abuse is soliciting proposals from qualified organizations having the capability to conduct Phase I and II clinical trials for the treatment of cocaine and opiate addiction under the current Food and Drug Admistration regulations and Good Clinical Practice guildelines. The work shall involve: a) protocol development and review; b) solicitation and recruitment of a network of qualified clinical trial centers; c) initiation, coordination, monitoring and management of clinical trials; d) selection of a central pharmacy and supervision of the distribution of clinical supplies; e) selection of a central laboratory to perform the routine laboratory tests (i.e., CBC, urinalysis, etc.) performed at the clinical centers and, f) preparation of a written study summary report of adequate quality to support NDA submission(s). The nature of the clinical trials shall be to determine the tolerated dose range, the dosing regimen, the safety profile and estimates of pharmacokinetic and pharmacodynamic parameters and to evaluate the efficacy of the investigational compounds or marketed medications. The offeror must be highly experienced in conducting the monitoring Phase I and II clinical trials. It is estimated that a 4.5 year contract will result from this procurement. Estimated issuance date of RFP No. N01DA-5-8050 is February 24, 1995 and responses are due to be received in the Contracting Office 75 calendar days thereafter. Written requests for copies of the solicitation will be honored if received within sixty calendar days after issuance of the solicitation. Written requests received after this period will be filled on a first-come, first-served basis until the supply is exhausted; however, there is no assurance that copies requested after the sixtieth day will reach the requestor before the due date for receipt of responses. Written requests shall be forwarded to the attention of the Contract Specialist. (0033)

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