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)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |