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FBO DAILY ISSUE OF MAY 25, 2008 FBO #2372
SOURCES SOUGHT

A -- Coordinating Center for the National Institute on Alcohol Abuse and Alcoholism Clinical Investigations Group (NCIG)

Notice Date
5/23/2008
 
Notice Type
Sources Sought
 
NAICS
541711 — Research and Development in Biotechnology
 
Contracting Office
Department of Health and Human Services, National Institutes of Health, National Institute on Alcohol Abuse and Alcoholism, R&D Contracts Management Branch, 5635 Fishers Lane, Room 3016, MSC 9304, Bethesda, Maryland, 20892-9304
 
ZIP Code
20892-9304
 
Solicitation Number
NIAAA-09-01
 
Response Due
6/30/2008
 
Point of Contact
Gwennifer Epps,, Phone: 301-443-4789, Matthew L Packard,, Phone: 301-443-3041
 
E-Mail Address
ge50d@nih.gov, packardm@mail.nih.gov
 
Small Business Set-Aside
Service-Disabled Veteran-Owned
 
Description
To address the present and anticipated future needs of the Medication Development Program of National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health, the NIAAA is requesting proposals from Service Disabled Veteran Organizations to provide clinical trial coordination, clinical data management, and regulatory support for phase 2 multicenter clinical trials. The Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, serve as coordinating center data management center that accomplishes the work described below. In general terms, the contractor shall provide resources and services necessary to support a broad range of activities required to effectively manage multicenter (up to six sites) phase 2 clinical trials. This includes multiple activities requiring advanced expertise in the management of clinical trials. Although distinct performance areas have been identified, it is impossible to anticipate every need of the NIAAA, both because the clinical trial and its associated unique demands are unknown, and because of possible unanticipated NIAAA and NIH policy changes. The contractor shall provide clinical trials professionals with broad enough expertise to handle such unanticipated needs. It is anticipated that the Contractor will provide the following clinical trial support services: •Clinical trial coordination •Clinical site selection based on criteria specified by NIAAA •Preparation of operations and pharmacy manuals •Preparation of customized database •Preparation of case report forms •Data coordination and quality control •Clinical monitoring •Packaging, shipping and coordination of study medication •Logistical and meeting services •Regulatory support to include preparation of Investigational New Drug (IND) applications, annual reports, and IND amendments •Adverse event and Serious adverse event reporting •Statistical support and data analysis •Final clinical study report preparation.
 
Web Link
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=6012b245be494fc06613abfe089f33d0&tab=core&_cview=1)
 
Record
SN01579924-W 20080525/080523214905-6012b245be494fc06613abfe089f33d0 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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