SOURCES SOUGHT
A -- NINDS Center for Clinical Research Resources
- Notice Date
- 11/14/2016
- 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
- SBSS-NIH-NINDS-17-03
- Archive Date
- 12/12/2016
- Point of Contact
- Jason S Williams, Phone: (301) 496-5985, Kirkland L. Davis, Phone: (301) 496-1813
- E-Mail Address
-
willjas@nida.nih.gov, kd17c@nih.gov
(willjas@nida.nih.gov, kd17c@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- PURPOSE OF NOTICE: The purpose of this announcement is to identify and assess the availability of small business concerns with the requisite capabilities and qualifications to operate and maintain the NINDS Center for Clinical Research Resources which provides 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 for neurological diseases and disorders. The envisioned contract award is a follow-on requirement to the current National Institute of Neurological Disorders and Stroke (NINDS) Center for Clinical Trial Resources currently being performed under contract HHSN271201200034C at the EMMES Corporation. 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. BACKGROUND : The NINDS Office of Clinical Research (OCR) 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 NINDS Center for Clinical Research Resources is to 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 in the area of neurological diseases and disorders. NAICS CODE and APPLICABLE SMALL BUSINESS QUALIFICATION : Based on the technical and scientific nature of the expertise required and the work to be performed for the subject requirement in support of clinical research in the Neurosciences, the work requirement is best classified by North American Industry Classification System (NAICS) code 541712 "Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)". Therefore, the small business size standard for this announcement is 1,000 or fewer employees. Furthermore, per FAR 19.001, a small business concern means any business entity organized for profit (even if its ownership is in the hands of a nonprofit entity) with a place of business in the United States or its outlying areas and makes a significant contribution to the U.S. economy through payment of taxes and/or use of American products, material and/or labor, etc.. 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. Small business concerns that meet the applicable NAICS code size standard and who believe that they have the capabilities, capacity, experience and qualifications to provide the full range of services described for the NINDS Center for Clinical Research Resources are asked to address each of the areas described in the Information Requested section below as part of a submitted Capability Statement. Please ensure that your response is complete and sufficiently detailed to assist in our evaluation as to whether or not this requirement could be set-aside for small business participation only. If responses indicate a reasonable expectation of obtaining competitive offers from two or more responsible and capable small business concerns, the anticipated Request for Proposals may be set-aside for small business participation only and a future Pre-Solicitation Notice for this requirement would indicate this determination. Responses to this announcement must address how your business meets the applicable NAICS code size standard and must include the respondents' DUNS number; organization name; organization address; point of contact, including title, address, telephone and e-mail address; and your current small business size status (e.g. small, small disadvantages business, HUBZone small business, woman-owned small business, 8(s), etc.) pursuant to the applicable NAICS code specified above (NAICS 541712). INFORMATION REQUESTED FOR CAPABILITY STATEMENTS: Small business concerns that meet the applicable NAICS code size standard and who believe that they have the expertise, experience and capacity to provide the full range of services of the NINDS Clinical Research Resource Center as described in this announcement are asked to address each of the following items in your response to this Small Business Sources Sought Announcement as part of your submitted Capability Statement: 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 18 site visits per year, approximately 12 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 whom 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, especially in early phase clinical trials, as well as data management/clinical research coordination related activities whom the Contractor would be able to utilize for this project in their Capability Statements. 3. Provide technical support, guidance and services in clinical dataset 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 archiving and dissemination of de-identified data sets, knowledge and application of HIPAA and DHHS regulations 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 within two weeks of request. Contractor shall have the ability to archive and disseminate the 40 data sets currently in existence and to receive, archive, and disseminate new 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 23 diseases/disorders identified on the NINDS Common Data Elements website ( http://www.commondataelements.ninds.nih.gov ) and have the ability to coordinate development and publication of an additional 2 disease/disorder common data element sets per annum for the duration of this project. Prospective Contractors shall also identify doctoral-level professional personnel with knowledge of neurological disorders as well as individuals with at least 5 years experience in Case Report Form development and curation of data element libraries whom the Contractor would be able to utilize for this project in their Capability Statements. 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). 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 and generic marketing brochures will not be evaluated. ALL CAPABILITY STATEMENTS ARE DUE BY 3:30 PM EASTERN STANDARD TIME ON DECEMBER 7, 2016. Please submit one (1) electronic copy of your response via e-mail to Mr. Jason Williams, Contracting Officer, at willjas@nida.nih.gov in MS Word (.doc, docx) or Adobe Portable Document Format (PDF). The e-mail subject line must specify SBSS-NIH-NINDS-17-03. 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NINDS/SBSS-NIH-NINDS-17-03/listing.html)
- Place of Performance
- Address: Contractor's facility and research sites (monitoring visits). Meetings to be held in Bethesda, MD., United States
- Record
- SN04327628-W 20161116/161114234858-e64a0c806eb455c5e9068e89525514a8 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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