SPECIAL NOTICE
A -- Sole Source for non-personal services for clinical protocol development, project management, and data analysis for a short-term (four day) anti-plaque chewing gum efficacy study.
- Notice Date
- 5/28/2013
- Notice Type
- Special Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH10327607
- Archive Date
- 8/26/2013
- Point of Contact
- Terry Bice, 210-539-3295
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(terry.g.bice.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- The United States Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, MD intends to issue a sole source award to Clinical Research Management, Inc. (CRM), on behalf of the US Army Institute of Surgical Research (USAISR) Dental and Trauma Research Detachment (DTRD), for non-personal services for clinical protocol development, project management, and data analysis for a short term (four day) anti-plaque chewing gum efficacy study to include: a. Developing a clinical protocol and supporting documents (i.e. consent form and source documents) designed to test the efficacy of anti-plaque chewing gum. b. Providing regulatory consultation and support, including preparation of study data for submission to the US Food and Drug Administration (FDA) c. Providing clinical monitoring support to ensure the rights and wellbeing of the human subjects are protected d. Providing project management to ensure the trial data are accurate, complete and verifiable e. Providing project management to ensure the conduct of the trial is in compliance with Good Clinical Practices (GCP), the approved protocol, and applicable regulatory requirements f. Providing exertise in statistical support This notice of intent is for informational purposes only. All sources eligible to provide this service must respond in writing. Responses must be supported with clear and convincing evidence to articulate the ability to provide services outlined above. A request for documentation will not be considered as an affirmative response. If no responses are received within 15 days of publication of this notice to the effect that comparable services are available, and that it is more advantageous to the Government than obtaining these services through a sole-source contract, then a sole source acquisition award will be made. Response to this notice is to be sent to terry.g.bice.civ@mail.mil.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH10327607/listing.html)
- Record
- SN03073334-W 20130530/130528235141-8c8e8211fb03ab8e06bde05ca9b74238 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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