CLINICAL OPERATIONS CONTRACT FOR MEDICATIONS DEVELOPMENT PROGRAM NIH Guide, Volume 22, Number 13, April 2, 1993 RFP AVAILABLE: N01DA-3-8400 P.T. 34 Keywords: Clinical Medicine, General Pharmaceuticals National Institute on Drug Abuse The National Institute on Drug Abuse (NIDA) is soliciting proposals from organizations capable of selecting sites for the conduct of clinical trials and supervising their operation. These will be Phase I and II trials, primarily for the treatment of cocaine and opiate addiction under the current Food and Drug Administration (FDA) regulations and Good Clinical Practice (GPC) guidelines. Performance of the work shall involve: protocol development and review; solicitation and recruitment of a network of qualified clinical trial centers; obtaining FDA registration, DEA registration, and ongoing regulatory compliance; initiation, coordination, monitoring, and management of clinical trials; selection of a central pharmacy and supervision of the distribution of clinical supplies; selection of a central laboratory to accomplish the routine laboratory tests (e.g., CBC, urinalysis) performed at the clinical center; data management; clinical and statistical analysis; and preparation of a written study summary report of adequate quality to support NDA submission(s). The nature of the clinical trials will be to determine the tolerated dose range, the dosing regimen, the safety profile, and estimates of pharmacokinetics and pharmacodynamic parameters. The contractor also will evaluate the efficacy of the investigational compounds or marketed medications. Estimated issuance date of RFP No. N01DA-3-8400 is April 16, 1993, and responses are due to be received by the Contracting Officer 45 calendar days thereafter. The NIDA plans to make one award from this solicitation. INQUIRIES Written requests are to be forwarded to: Kenneth E. Goodling, Contract Specialist National Institute on Drug Abuse Parklawn Building, Room 10-49 5600 Fishers Lane Rockville, MD 20857 This advertisement does not commit the Government to make an award. .
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