Inactive Total Small Business Set-Aside (FAR 19.5)

The Government is seeking Capability Statements on behalf of The National Institute on Drug Abuse (NIDA) Department of Therapeutics and Medical Consequences (DTMC) from Small Business organizations un... The Government is seeking Capability Statements on behalf of The National Institute on Drug Abuse (NIDA) Department of Therapeutics and Medical Consequences (DTMC) from Small Business organizations under the North American Industry Classification System (NAICS) code 541715, that can provide pharmacokinetic (PK) and pharmacodynamics (PD) aspects of the medications development. No actual clinical or laboratory studies will be carried out under this contract. The Contractor shall prepare study protocols, monitor clinical studies to assure that pertinent FDA regulations are met, perform data management and process clinical and pharmacokentic data, conduct PK, PD, and statistical analyses, and prepare study reports. The data/reports will be submitted to the FDA in support of IND’s (Investigational New Drugs) and NDA’s (New Drug Applicants).