SOURCES SOUGHT
R -- Protocol Auditing and Data Safey Monitoring Committee
- Notice Date
- 3/15/2011
- Notice Type
- Sources Sought
- NAICS
- 541611
— Administrative Management and General Management Consulting Services
- 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
- NICHD-11-057
- Archive Date
- 4/8/2011
- Point of Contact
- Patricia Haun, Phone: 301-443-7786
- E-Mail Address
-
haunp@mail.nih.gov
(haunp@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is conducting a market survey to determine the availability and technical capability of qualified small business, veteran-owned small business, service-disabled veteran-owned small business or HUBZone small businesses. The NICHD has requested that a Contractor provide periodic clinical research support services to include regulatory affairs, clinical operations, data management, statistical analysis and medical writing. This will involve auditing, protocol development, monitoring and statistical support services that will have significant training in Good Clinical Practice (GCP) compliance and experience in the management, conduct, analysis of and report writing for clinical trials, including: clinical study design; protocol writing; protocol review; GCP training; clinical site initiation for new clinical studies; clinical study site interim monitoring; clinical study site end of study closeout; mock FDA audit of clinical site and study documents; GCP audits of clinical study results and reports; statistical analysis of clinical study data; statistical analysis of safety data for Data Safety Monitoring Committee (DSMC); statistician as member in DSMC; integrated summary of safety and integrated summary of efficacy; safety databases; statistical section of clinical protocol; statistical analysis plan for clinical study; presentation of clinical trial data analysis to FDA Advisory Committees; creation of automated randomization systems and codes for blinded clinical studies; and Clinical study report writing. This request is for interested firms with the capability of providing the required position to submit a capability statement to assist the Government in determining in accordance with Federal Acquisition Regulation (FAR) 19.502-2(b) whether or not this procurement will be set-aside for any of the programs described above. The intended procurement will be classified under North American Industrial Classification (NAICS) code 541611with a size standard of $7.0. All respondents are requested to identify their firm's size and type of business. Interested firms responding to this market survey must provide (a) capability statement demonstrating their experience, skills and capability to fulfill the Government's requirements for the above. The capability statement shall be in sufficient enough detail, but not to exceed 10 pages, so that the Government can determine the experience and capability of your firm to provide the requirements above. Your capability statement, not to exceed 10 pages, should include references. A copy of the capability statement must be received at the address identified in this synopsis by no later than close of business (3:00p.m local time at designated location) on March 24, 2011. Responses by fax or e-mail WILL NOT BE ACCEPTED. This synopsis is for information and planning purposes and is not to be construed as a commitment by the Government, nor will the Government pay for information solicited.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NICHD/NICHD-11-057/listing.html)
- Record
- SN02401326-W 20110317/110315235034-e2a5161ac2ae2a2fd14223446512361f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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