CLINICAL OPERATIONS CONTRACT - REGULATORY AFFAIRS

NIH GUIDE, Volume 24, Number 7, February 24, 1995



RFP AVAILABLE:  N01DA-5-8051



P.T. 34



Keywords:

  Drugs/Drug Abuse 

  Addiction 

  Clinical Trial 



National Institute on Drug Abuse



The National Institute on Drug Abuse (NIDA) is soliciting proposals

from qualified organizations having the capability to provide

regulatory affairs resources supporting the conduct of Phase I and II

clinical trials for the treatment of cocaine and opiate addiction

under the current Food and Drug Administration regulations and Good

Clinical Practice guidelines.  The work will involve:  (a) provision

of regulatory affairs support to the Clinical Operations Contract;

(b) ensuring regulatory compliance during protocol development and

review; (c) ensuring regulatory compliance during conduct of each

clinical trial; (d) providing a regulatory strategy plan for each

compound under development; (e) plan, compile and file regulatory

submissions; (f) interact with regulatory and government agencies;

and (g) prepare written study summary reports of adequate quality to

support NDA submissions.  The nature of the clinical trials will be

to determine the tolerated dose range, dosing regimen, 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

the field of regulatory science and providing regulatory affairs

support for Phase I and II clinical trials.  It is estimated that a

4.5 year contract will result from this procurement.  Estimated

issuance date of Request for Proposals (RFP) No. N01DA-5-8051 is

February 24, 1995 and responses are due to be received in the

Contracting Office 60 calendar days thereafter.



INQUIRIES



Written requests may be forwarded to:



Kenneth E. Goodling

Contracts Management Branch

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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