SOLICITATION NOTICE
R -- Clinical and Data Management Services
- Notice Date
- 1/25/2005
- Notice Type
- Solicitation Notice
- NAICS
- 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
- 20892
- Solicitation Number
- N01DA-5-8857
- Response Due
- 3/28/2005
- Point of Contact
- Mandy Parham, 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
-
mp497q@nih.gov, kg25d@nih.gov
- Small Business Set-Aside
- Total Small Business
- Description
- The National Institute on Drug Abuse intends to solicit proposals under a 100% small business set aside (NAICS 541710 – 500 employees) from qualified small businesses with the in-house capacity to provide clinical and data operations and management services in support of Phase I, Phase II and/or Phase III clinical trials being run by NIDA’s Division of Pharmacotherapies and Medical Consequences of Drug Abuse. The Contractor shall be responsible for the a) preparation of clinical trial data acquisition tools, b) regulatory services, c) clinical trial data management operations, d) clinical monitoring for compliance with FDA regulations, HIPPA regulations and GCP guidelines, e) establishment of an analytical data base for statistical analysis required for interim and/or final study reports suitable for submission to support Investigational New Drugs (INDs) or New Drug Applications (NDA) applications, f) preparation of reports, and g) participation in project team meetings and/or other meetings. No actual clinical or laboratory studies will be conducted under this contract. The data reports and other documents will be submitted to FDA in support of IND’s and NDA’s. Estimated issuance date of RFP N01DA-5-8857 is on or about February 9, 2005. We anticipate multiple awards for this contract, each for a period of three years with two 1-year options. There will be two option years that may be exercised following this period. You can access the RFP through the FedBizOpps 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 March 28, 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 (25-JAN-2005). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 02-AUG-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.
(http://www.eps.gov/spg/HHS/NIH/NIDA-01/N01DA-5-8857/listing.html)
- Record
- SN00860916-F 20050804/050802213251 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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