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This Sources Sought opportunity from Department Of Defense was posted on January 5, 2011. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

A--Full service Contract Research Organization (CRO)

Closed
DVC0190-10Federal

Contract Overview

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DynPort Vaccine Company LLC, acting as the prime systems contractor for the Department of Defense Joint Vaccine Acquisition Program, is seeking a full service Contract Research Organization to support a Phase 3 clinical trial for the Recombinant Botulinum Vaccine A/B. The study aims to evaluate safety and immunogenicity in approximately 4,950 adult volunteers aged 18 to 55 using a 2:1 randomization ratio against a placebo. The project is scheduled to run from January 2012 through March 2015 and must be conducted using domestic resources and facilities. Qualified candidates must maintain a Federalwide Assurance with the HHS Office for Human Research Protections and demonstrate proficiency in Microsoft Project and earned value management. While government contracting experience is strongly preferred, the contractor must acknowledge that indemnification for the CRO or third party vendors will not be provided. Submissions must include detailed business information, including DUNS number, company classification, and confirmation of a government approved accounting system.

General Info

DynPort seeks a CRO for Phase 3 Botulinum Vaccine trials from 2012 to 2015.

NAICS

541711 - Research and Development in Biotechnology

Place of Performance

RDECOM Contracting Center - Natick R&D (RDECOM-CC) ATTN: AMSRD-ACC-N, Natick Contracting Division (R and BaseOPS), Building 1,, MA

Set-Aside

NONE

Documents

0

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Timeline

PhaseClosed
Posted

Sources Sought

Response Deadline

Deadline has passed

Submission Closed

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Organization & Contact Information

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AgencyDepartment Of Defense → W6QK Acc-Apg Natick
ContactsNo contacts available
OfficeNATICK, MA, 01760-5011, USA
Office AddressNATICK, MA, 01760-5011, USA
ContactsNo contact information available

Full Description

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Please provide your capabilities statement for the following work: DynPort Vaccine Company LLC, a CSC company (DVC) is the prime systems contractor for the United States (U.S.) Department of Defense Joint Vaccine Acquisition Program (JVAP) and is responsible for the advanced development and licensure with the U.S. Food and Drug Administration (FDA) of vaccines and other biological products designed to protect against a variety of biological agents. A Phase 3 clinical trial is planned as a well-controlled study to evaluate the safety and immunogenicity of Recombinant Botulinum Vaccine A/B, referred to as rBV A/B, in an adult population 18 through 55 years of age. In this Phase 3 clinical study, approximately 4,950 volunteers will be randomized in a 2:1 (rBV A/B to Placebo) ratio. This Phase 3 clinical trial is expected to be conducted using domestic resources and facilities. The project is expected to be conducted from January 2012 through March 2015. Full service Contract Research Organization (CRO) capabilities are required. The CRO must have and maintain a Federalwide Assurance with the U.S. Department of Health and Human Services (HHS), Office for Human Research Protections (OHRP). Government contracting experience is strongly preferred. Knowledge and experience using earned value management (EVM) and Microsoft Project is required. Indemnification of the CRO or third party vendors such as the clinical sites will not be offered. Each response should include the following Business information: a. DUNS number b. Company Name c. Company Address d. Company Points of Contact (both technical and administrative/business), including names, titles, addresses, telephone and fax numbers and email addresses. e. Do you have a Government-approved accounting system? f. Type of Company (i.e. small business, 8(a), woman owned, veteran owned, etc). ***** Contact Information: Inquiries shall be transmitted either via email or paper copy to Linda S. Howell, Sr. Principal Subcontract Administrator, DVC, a CSC Co. at 64 Thomas Johnson Drive, Frederick MD 21702 or via email to: contact@example.gov. ***** Disclaimer: This notice does not obligate DVC to award a contract or otherwise pay for the information provided in response. Note that DVC will not entertain questions regarding this Market Research; however, general questions can be presented in your response. Confidentiality: No proprietary, classified, confidential or sensitive information should be included in your response.

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