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

Solicitation Number: NIAAA-09-01
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Institute on Alcohol Abuse and Alcoholism, R&D Contracts Management Branch
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:
NIAAA-09-01
:
Award
:
January 15, 2008
:
HHSN275200900005C
:
$22,700,000
:
FAST-TRACK Biologics, LLC
:
5 Paramus Ct.
North Potomac, Maryland 20878
United States
:
Added: May 23, 2008 4:38 pm
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.





Added: Sep 09, 2008 9:27 pm
Please see Amendment Number 2 - Questions and Answers received from potential offerors have been posted.
Added: Feb 12, 2009 9:23 am
Please see Award Notice of Contract number: HHSN275200900005C
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Amendment 1

Type:
Mod/Amendment
Posted Date:
June 2, 2008
Description: Amendment 1- Coordinating Center for the National Institute on Alcohol Abuse and Alcoholism Clinical Investiagations Group. (Note: requires Capability statement)

NIAAA-09-01

Type:
Other (Draft RFPs/RFIs, Responses to Questions, etc..)
Label:
NIAAA-09-01
Posted Date:
July 15, 2008
Description: Request for Proposal: NIAAA-09-01, Titled: Coordinating Center for the National Institutes on Alcohol Abuse and Alcoholism Clinical Investigations Group, (NCIG)

Amendment 2

Type:
Mod/Amendment
Posted Date:
September 9, 2008
Description: Amendment 2, Questions and Answers to RFP NIAAA-09-01
:
5635 Fishers Lane
Room 3016, MSC 9304
Bethesda, Maryland 20892-9304
:
Gwennifer Epps,
Contract Specialist
Phone: 301-443-4789
Fax: 301-443-3891
:
Matthew L Packard,
Contracting Officer
Phone: 301-443-3041
Fax: 301-443-3891