SPECIAL NOTICE
A -- Support services for the Hyperbaric Oxygen Research Program as the Data Analysis and Management Center (DAMC) with EMMES Corporation
- Notice Date
- 4/30/2013
- Notice Type
- Special Notice
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- ACC-APG - Natick (SPS), ATTN: AMSRD-ACC-N, Natick Contracting Division (R and BaseOPS), Building 1, Kansas Street, Natick, MA 01760-5011
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY13C0052
- Archive Date
- 7/29/2013
- Point of Contact
- Nathan C. Jordan, 508-233-6034
- E-Mail Address
-
ACC-APG - Natick (SPS)
(nathan.c.jordan@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- The U.S. Army Contracting Command, Aberdeen Proving Ground, Natick Contracting Division, has a requirement in support of the US Army Medical Materiel Development Activity (USAMMDA) to procure a broad range of support services for the Hyperbaric Oxygen Research Program as the Data Analysis and Management Center (DAMC) with EMMES Corporation under the authority of FAR Subpart 6.302-1(a)(2)(ii)(A) and (B). The Contractor shall establish and manage the DAMC to provide statistical, data management, clinical, technical, regulatory, training and administrative support. This is a follow-on contract in which the contractor has developed a proprietary electronic data capture management system and regulatory document manage system to support the FDA-regulated clinical trial. These are critical tasks under FDA regulations as spelled out in 21 CFR 312 (Investigation New Drug) and ICH E6 (Good Clinical practices). Using another source in the middle of the study (the programming of the data and document systems is completed, fully validated to FDA specifications, and in production with 30% of study volunteers are enrolled), would cause immediate non-compliance, and would result in a substantial duplication of time and costs to the Government. Moreover, it would cause at least another one year delay in answering this critical clinical question involving TBI care for our wounded warriors. This continued effort will be for a single 2 year period of performance with 2 optional 6 month periods. Interested parties may identify their interest and capability to respond to this requirement to the U.S. Army RDECOM Contracting Center, Natick Contracting Division via e-mail to: Nathan.c.jordan.civ@us.mail.mil no later than 9:00 a.m. on May 14, 2013.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/d5f561876a2bb126db908f01a4055853)
- Record
- SN03049484-W 20130502/130430235357-d5f561876a2bb126db908f01a4055853 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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