MODIFICATION
A -- NICHD Clinical Trails Network
- Notice Date
- 6/24/2009
- Notice Type
- Modification/Amendment
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, Maryland, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- SBSS-NICHD-CRMC-2010-02
- Point of Contact
- Alice M. Pagán, Phone: 301-435-6959, Elizabeth J. Osinski, Phone: 301-435-6947
- E-Mail Address
-
ap425k@nih.gov, eo43m@nih.gov
(ap425k@nih.gov, eo43m@nih.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- This amendment provides clarifications based on inquiries received. The responses to inquires are as follows: 1. It is our understanding that this SS is for a Coordinating Center (CC) for the Clinical Trials Network (CTN). Please confirm. Please see announcement under Background (first paragraph). This procurement is for the Clinical Trials Network (CTN). NICHD has previously advertised and currently is negotiating the BPCA coordinating center contract. 2. Will the Clinical Sites will be awarded under a separate contract/grant? It appears that many of the activities described in Technical Requirements should be performed by the sites (conducting clinical trials, formulations, bioavailability/bioequivalence) or by specific contractors. Please see announcement under Background (first paragraph), the clinical studies will be conducted under the CTN. 3. Is the CC expected to have expertise in study design and the ability to conduct (e.g., enlist sites and enroll participants)? YES. Please see announcement under Background (first paragraph) – “NICHD is seeking for a small business capable of designing, conducting and overseeing the clinical, scientific, and technical aspects of pediatric drug development, including, but not limited to, pre-clinical studies, formulations development, and Phase 1-3 pediatric clinical trials. The purpose of this contract will be to create a Pediatric Clinical Trials Network (CTN) with experts knowledgeable about pediatric drug. The purpose of this contract will be to create a Pediatric Clinical Trials Network (CTN) with experts knowledgeable about pediatric drug development, who, through their knowledge and experience, can design, conduct and manage pre-clinical and pediatric clinical trial activities in various pediatric therapeutics areas.” 4. If the BPCA DCC is tasked with Statistical analysis, what role will the CTN CC play in statistical analysis (technical requirement)? The CTN will be expected to have staff with expertise in statistical analysis although this function will primarily be accomplished by the DCC under separate contract.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NICHD/SBSS-NICHD-CRMC-2010-02/listing.html)
- Place of Performance
- Address: Contracts Management Branch, 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, Maryland, 20892-7510, United States
- Zip Code: 20892-7510
- Zip Code: 20892-7510
- Record
- SN01855667-W 20090626/090625000923-0097a4ed6bbe80521cf078ea7120a41d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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