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A -- Medical Writing, Report Preparation and Project Management

Notice Date
Notice Type
Solicitation Notice
541710 — Research and Development in the Physical, Engineering, and Life Sciences
Contracting Office
Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6101 Executive Boulevard, Bethesda, MD, 20892
ZIP Code
Solicitation Number
Response Due
Point of Contact
Pedro Godinez, Contract Specialist, Phone 301.443.6677, Fax 301.443.7595, - Kenneth Goodling, Contracting Officer, Phone (301)443-6677, Fax (301)443-7595,
E-Mail Address
pg186o@nih.gov, kg25d@nih.gov
Small Business Set-Aside
Total Small Business
The National Institute on Drug Abuse (NIDA) intends to solicit proposals under a 100% small business set-aside (NAICS 541710, 500 employees) from qualified small businesses to provide resources to provide medical writing and project management support of Phase I, Phase II, and/or Phase III clinical trials being run by the Division of Pharmacotherapies and Medical Consequences of Drug Abuse. The contractor shall be responsible for the: a) protocol development, b) preparation of summary statistical analysis plans, c) preparation of data safety and monitoring board (DSMB) reports, preparation of clinical study reports d) coordination of final clinical study reports, and e) project management. No actual clinical or laboratory studies will be conducted under this contract. The data reports and other documents will be submitted to the FDA in support of Investigational New Drugs (INDs) and New Drug Applications (NDAs). We anticipate multiple awards on this project. Each contract will have a performance period of three years with two 1-year options. RFP No. N01DA-5-8856 will be available electronically on or about March 3, 2005. You will access the RFP through the FedBizOpps (URL: http://www.fedbizopps.gov) or through the NIDA website: (URL: http://www.nida.nih.gov/RFP/RFPList.html). Please note that NIDA uses a streamlined RFP format which includes only the Work Statement, Deliverables, Reporting Requirements, Special Requirements, Mandatory Qualifications, Technical Evaluation Criteria, and other necessary Proposal Preparation Instructions. All information required for the submission of a proposal is contained in or accessible through the streamlined RFP package. Response to the RFP will be due on or about April 18, 2005. NIDA will consider proposals submitted by any responsible offeror. This advertisement does not commit the Government to award a contract. See Notes 1 and 26. NOTE: THIS NOTICE MAY HAVE POSTED ON WWW.FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (16-FEB-2005). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 30-SEP-2005, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
Web Link
Link to FedBizOpps document.
SN00907893-F 20051002/050930213808 (fbodaily.com)
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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