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

R -- CLINICAL OPERATIONS - DATA MANAGEMENT AND BIOSTATISTICS SOL N01DA-5-8052 DUE 051095 POC Point of Contact, Kenneth E. Goodling, Contracting Officer (301) 443-6677 The National Institute on Drug Abuse is soliciting proposals under a 100% Small Business Set-Aside (SIC 7379 - $18M) from qualified small businesses having the capability to provide data management and biostatistical services in support of the conduct of Phase I and II clincial trials for the treatment of cocaine and opiate addicition under the current Food and Drug Administration regulations and Good Clinical Practice guidelines. The work shall involve; a) provision of data management and biostatistical support to the Clinical Trials contract; b) statistical input during protocol development and review; c) establishment of and maintaining a data base for each clinical trial; d) ensure that the acquired data is of the highest quality (i.e., data integrity); e) ensure data security; f) data analyses; g) provision of a data management strategy and plan for each compound under development; h) provision of a biostatistical strategy and plan for each compound under development and i) preparation of a written study sumary 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 investigational compounds or marketed medications. The offeror must be highly experienced in establishing and maintaining a qualified data management center and analyzing and managing data acquired from clinical trials. It is estimated that a 4.5 year contract will result from this procurement. Estimated issuance date of RFP No. N01DA-5-8052 is February 24, 1995 and reponses 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 responses 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 Contracting Officer. See Note 1. (0034)

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