SOURCES SOUGHT
A -- NINDS Center for Clinical Trial Resources
- Notice Date
- 11/8/2011
- Notice Type
- Sources Sought
- 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 Neurological Disorders and Stroke, 6001 Executive Boulevard, Neuroscience Center, Suite 3287, MSC 9531, Bethesda, Maryland, 20892-9531
- ZIP Code
- 20892-9531
- Solicitation Number
- SS-NINDS-12-01
- Archive Date
- 12/8/2011
- Point of Contact
- Jason J Williams, Phone: 301-496-4985, Laurie A Leonard, Phone: 301 496-1813
- E-Mail Address
-
willjas@mail.nih.gov, ll44s@nih.gov
(willjas@mail.nih.gov, ll44s@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Institute of Neurological Disorders and Stroke (NINDS) is interested in identifying Small Business organizations with requisite qualifications to operate and maintain the NINDS Center for Clinical Research Resources. The NINDS Office of Clinical Research is charged with ensuring the highest quality of each NINDS-funded clinical research project and compliance with DHHS/NIH/NINDS regulations regarding human subject protection and safety monitoring. To ensure the highest quality product and most efficient use of resources, OCR has established a programmatic requirement for clinical research-related scientific and technical support in the form of the proposed Center. The prospective Contractor will provide scientific and technical support toward the conduct of NINDS-sponsored clinical research in the areas of Quality Assurance/Quality Control clinical trial monitoring, statistical and methodological support, clinical data acquisition and archiving support and common data element development support. The NINDS is seeking Small Business Capability Statements at this time in order to determine if this future requirement can be set-aside exclusively for small business concerns. THIS ANNOUNCEMENT IS NOT A REQUEST FOR PROPOSALS, and if your business concern is NOT a small business, there is no need to respond to this announcement. Once a determination is made regarding the suitability of this future requirement for a small business set-aside (or an open competition to include both large and small businesses), a separate Pre-Solicitation Announcement would be issued in advance of the release of a Request for Proposals. The applicable North American Industry Classification System (NAICS) code for this requirement is 541712. Therefore, the small business size standard for this announcement is 500 or fewer employees. Please note that in order to qualify as an eligible small business for purposes of a small business set-aside (where large businesses would be excluded from competing), at least 50% of the direct labor cost must be "in-house". Specifically, FAR 52.219-14, "Limitations on Subcontracting," states that "at least 50 percent of the cost of contract performance incurred for personnel shall be expended for employees of the concern." Submitted Capability Statements must address how the business meets the applicable size standard. To be deemed capable, a small business must demonstrate their ability and related experience in a requirement-specific Capability Statement to: 1. Provide technical support in quality assurance and quality control in the conduct of NINDS-sponsored clinical research to ensure that the data resulting from a clinical research project are of the highest quality and are considered valid and credible within the scientific and clinical community, as well as the general public. In order to be deemed capable, prospective Contractors shall demonstrate the following in their submitted Capability Statements in response to this announcement: knowledge and experience in interpreting and implementing Good Clinical Practice (GCP) Guidelines at research sites, demonstrated knowledge and experience in conducting quality assurance and quality control site visit monitoring and data audits at clinical trial coordinating centers and research sites and demonstrated knowledge and experience in developing and revising Standard Operating Procedures for site visit monitoring. It is anticipated that there will be approximately 38 site visits per year, approximately 30 of which will be in the Washington, D.C. area. Contractor shall have the ability to conduct a site visit in the Washington D.C. area within 48 hours of notification. Prospective Contractors shall also identify a certified Clinical Research Associate with at least 10 years of relevant experience they would be able to utilize for this project in their Capability Statements. 2. Provide statistical and methodological support and analysis to the NINDS as related to the development of guidelines for prospective grant applicants and reviewers, the resolution of methodological problems in ongoing clinical activities, and overall statistical analysis of the NINDS clinical research portfolio to aid NINDS strategic planning. In order to be deemed capable, prospective Contractors must demonstrate in their Capability Statements knowledge and relevant experience in statistical research methodology in neurological disorders including meta-analysis or sub-analysis of data pertaining to neurological research. Prospective Contractors shall also identify a PhD level biostatistician with at least 5 years experience in neurology related statistical analysis as well as data management/clinical research coordination related activities the Contractor would be able to utilize for this project in their Capability Statements. 3. Provide technical support, guidance and services in clinical data acquisition, archiving, and distribution activities, in accordance with current NIH data sharing policy, in order to store and distribute NINDS-sponsored clinical research findings within the scientific research community. In order to be deemed capable, prospective Contractors shall demonstrate in their Capability Statements knowledge and relevant experience in clinical research data archiving and dissemination of de-identified data sets, knowledge and application of HIPPA and DHHS regulation regarding data confidentiality and data sharing, knowledge and experience in de-identifying data sets and the ability to distribute data sets in commonly used formats (SAS is preferred) and the ability to distribute data sets within two weeks of request. Contractor shall have the ability to receive and quickly archive 29 data sets currently in existence and can expect to receive data sets from approximately 5 large clinical trials per annum for the life of the contract requirement. 4. Provide scientific and technical support for the ongoing development of a core set, and several disease-specific sets, of Common Data Elements (CDEs) for use in NINDS-sponsored clinical research. This will include responsibility for updating and maintaining the NINDS-hosted Common Data Elements website (http://www.commondataelements.ninds.nih.gov). In order to be deemed capable, prospective Contractors must demonstrate in their Capability Statements knowledge and relevant experience in data standards related to scientific and technical support in the development of common data elements for clinical research and IT knowledge and experience in SharePoint and database and website design and maintenance. Prospective Contractors shall also demonstrate their capacity to develop Case Report Forms, perform literature searches, review Case Report Forms from ongoing or completed clinical studies, provide website training on the use of subject common data elements in research, provide materials for meetings,assist in drafting of disease-specific common data element publications, draft and present posters at national and international meetings and coordinate activities with multiple stakeholders (disease-specific working groups for Common Data Elements activities may contain up to 60 experts each). The prospective Contractor shall demonstrate the capacity to maintain the Common Data Elements activities on the 12 diseases/disorders identified on the NINDS Common Data Elements website (http://www.commondataelements.ninds.nih.gov) and have the ability to absorb an additional 2 disease/disorder common data element sets per annum for the duration of this project. The Contractor shall provide clinical research professionals with broad enough expertise to handle unanticipated needs. Examples of such possible needs include: preparation of the scientific background information needed to develop new scientific initiatives involving clinical research; and dissemination and translation of results from clinical research to the clinical community (patient and physician education). Small Businesses that meet the applicable size standard and believe that they have the capabilities described above are encouraged to submit 3 copies of your written Capability Statement to the attention of Jason Williams, Contract Specialist at the address provided by 5:00 PM Local Time on 11/23/2011. Capability Statements should be limited to no more than 15 pages and should specifically address each of the competencies stated above. A generic marketing brochure would not suffice for purposes of determining a small business to be capable for this requirement. If responses indicate a reasonable expectation of obtaining competitive offers from two or more responsible and capable small business concerns, the anticipated subsequent Request for Proposals will be set-aside for small businesses only and a future Pre-Solicitation Notice for this requirement would indicate this determination. This Small Business Sources Sought Announcement is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Government. The Government does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or the Government's use of such information. Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the Government's evaluation of the information received. However, should such a requirement materialize, no basis for claims against the Government shall arise as a result of a response to this Small Business Sources Sought announcement or the Government's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. Responses will be held in a confidential manner. Any proprietary information should be so marked. Please submit 3 copies of your Capability Statement to: Jason Williams, Contract Specialist, National Institutes of Health, NINDS Contracts Management Branch, 6001 Executive Blvd., Suite 3287, Rockville, MD 20852. Electronic submittal will also be accepted at willjas@mail.nih.gov (please format for printing
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NINDS/SS-NINDS-12-01/listing.html)
- Place of Performance
- Address: Contractor's facilty and research sites (monitoring visits). Meetings to be held in Bethesda, MD., United States
- Record
- SN02620357-W 20111110/111108235144-69dd1e1db61e7858cc7c15f7d57da0e4 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |