SOURCES SOUGHT
A -- Clinical Research Support Services
- Notice Date
- 1/12/2012
- 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 Environmental Health Sciences, Office of Acquisitions, Office of Management, 530 Davis Drive, Durham, North Carolina, 27713, United States
- ZIP Code
- 27713
- Solicitation Number
- NIHES2012138
- Archive Date
- 2/11/2012
- Point of Contact
- Hamilton L. Brown, Phone: 919-541-7821, Velvet m Torain, Phone: 919-541-0400
- E-Mail Address
-
hamilton.brown@nih.gov, torain@niehs.nih.gov
(hamilton.brown@nih.gov, torain@niehs.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; (a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. The NAICS code for the project is 541712 Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology) The small business size standard is 500 employees. BACKGROUND The Clinical Research Program (CRP) and the Division of Intramural Research (DIR) within the National Institute of Environmental Health Sciences (NIEHS) are seeking small business offerors who can conduct and/or provide support for various types of clinical research studies, including observational, epidemiological, and genetic studies and interventional clinical trials. Examples of observational studies to be covered by this contract include case report and case series, case-control, cross-sectional, and prospective and retrospective cohort studies. Epidemiological studies include the development and administration of a wide array of instruments to collect data from various populations, and environmental and biological specimens. Genetic studies include both case-control association and pedigree designs, and genetic statistical support. Interventional studies to be covered by this contract include: (1) efficacy trials of new treatments, new combinations of drugs; (2) prevention trials for diseases or disease progression in susceptible individuals using various therapies, diet and lifestyle changes, vitamins, minerals, and methods to minimize potentially toxic exposures; (3) diagnostic trials aimed at developing better tests or procedures for diagnosing a particular disease or condition; (4) prevalence or screening studies to determine the number of incident or prevalent cases of a condition in certain populations; and (5) quality of life trials to explore ways to improve comfort or quality of life of individuals with a certain disease or lifestyle by modifying risk factors. Small businesses responding to this sources sought will also be required to provide operational support for clinical research facilities including outpatient clinics. PURPOSE AND OBJECTIVES The NIEHS seeks capability statements from qualified small businesses to conduct or provide support for said clinical studies above. The ultimate design and oversight of implementation of these studies will be the responsibility of the NIEHS Task Leader initiating the study, but advice may be sought from the NIEHS Contracting Officer’s Technical Representative (COTR), Contractor or a contracted panel of experts. The extent of the Contractor's involvement with any given study shall vary depending on the support available in-house or through collaborators. At times, the Contractor shall carry out only selected study components. For example, for a given study the Contractor might conduct only the surveillance and recruitment phase, develop and administer study questionnaires, administer treatment or only collect biospecimens and environmental samples. At other times, the Contractor might conduct the entire study with oversight from the NIEHS Task Leader. The clinical studies to be supported by this contract will vary greatly in size and scope. For example, the Contractor might conduct a small study involving only local populations, or might conduct a highly complex world-wide multi-center study with multi-faceted components. Here, the Contractor shall be responsible for all study phases beginning with providing expertise for study design and planning, identifying and recruiting populations, collecting samples, conducting examinations and interventions, scientific review and oversight, data capture, management, and analyses, and disseminating results. Clinical studies under this contract shall require medical support. Therefore, the Contractor shall provide medical personnel and facilities and/or interact with medical personnel at other facilities including physicians' practices, clinics, hospitals and other research centers. The medical institutions might be local or distant, and thus require travel by contract personnel and/or study participants. The Contractor shall coordinate activities with various reference laboratories, medical clinics or other institutions, and collaborators with NIEHS personnel. The Contractor shall also provide operational support for the NIEHS Clinical Research Unit (CRU). This is an outpatient clinic on the NIEHS campus which sees up to 100 subjects per week. Here the Contractor shall provide personnel (study coordinators, physicians, nurses, therapists, technicians, administrative and other types of personnel). They will also provide IT support for electronic patient registration and data management within the CRU. Finally, all studies and/or tasks supported by the Contractor shall be conducted according to all relevant federal guidelines and regulations. Therefore, the Contractor shall have and maintain the knowledge of and experience with all relevant guidelines and regulations for using human beings in research studies, e.g., 45 CFR46 or the DHHS Common Rule, and those regulations for patient confidentiality such as the Health Insurance Portability and Accountability Act of 1966 (HIPAA). The Contractor shall also have an up-to-date Federal Wide Assurance number issued through the federal Office of Human Research Protections. PROJECT REQUIREMENTS Specifically, the Contractor shall (1) assist in study design and planning for a wide array of clinical studies or in the implementation of new clinical studies based on study designs provided by NIEHS Task Leaders, (2) assist in the preparation and review of all study documents including IRB and OMB protocols, informed consent forms, letters, study pamphlets, recruitment and informational materials, posters, websites and others, (3) identify and recruit relevant study populations either locally, nationally or internationally, (4) administer treatments and/or implement intervention in study subjects, (5) conduct diagnostic assessments or provide medical care to study subjects on an in-patient and/or out-patient basis, (6) assist in collection of data and biologic materials from study subjects, (7) store specimens collected during studies and maintain inventories, (8) isolate cellular, subcellular, and molecular fractions from biological samples and conduct biochemical, immunological, analytical, molecular and other types of laboratory assays, (9) develop study databases including the recording and summarizing of data and provide programming support for data analysis, (10) statistically analyze study data sets and develop reports, graphics, presentations and assist with manuscript preparation, (11) document all the individual steps in a specific study, and establish and maintain orderly records of all relevant material so that any aspect of a study can be reviewed by the NIEHS at any point during its course, (12) convert all original questionnaires and other relevant study materials to a form suitable for efficient long-term storage, e.g., microfilm, microfiche, CD ROM or optical disk storage, (13) when required, submit and implement a Quality Control or Quality Assurance Plan for individual studies. The Contractor will also provide personnel to staff the NIEHS CRU including nurses, study coordinators, physicians, therapists, technicians, administrative and other types of personnel. Staffing might be required full-time, part-time or be intermittent depending on the needs of the CRU and the needs for individual studies. The Contractor shall also provide expertise to the CRU for various aspects of running the clinic such as clinical monitoring, following Good Clinical Practices (GCP) and Good Laboratory Practices, and helping the CRU to obtain accreditation by the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO). ANTICIPATED PERIOD OF PERFORMANCE AND STAFFING The anticipated start date of the award is January 1, 2013. The planned total period of performance is ten (10) years. It is estimated that the total level of effort required is approximately 60,000 direct labor hours per year. GEOGRAPHIC RESTRICTION The Contractor shall for the duration of the period of performance have existing or establish offices within 30 miles of the NIEHS, Research Triangle Park, NC 27709. Established offices must be in place within 60 days of contract award. Frequent discussions and meetings take place between NIEHS COTRs and task leaders that necessitate that the Contractor be in close proximity to minimize the expense to the Government and increase direct communications. While the Contractor must maintain offices with key personnel located locally, the Contractor shall be required to conduct other activities (as described above) in various locations local and distant to the NIEHS. The Contractor shall also be required to conduct study activities internationally. In addition, since clinical studies will be conducted simultaneously at widespread geographical locations, the prospective Contractor should have at the time of submission of the proposal, established offices in various parts of the U.S. (or show the ability to set up field offices in the U.S. or foreign countries within 30 days of initiating a work assignment). GOVERNMENT FURNISHED EQUIPMENT AND MATERIALS The Contractor shall furnish their own equipment for establishing offices in the RTP area and other locations including furniture, computers, servers, printers, networking equipment, etc. The Contractor shall provide space in their facility or in a subcontracted facility for storing frozen and/or refrigerated biospecimens. In this case, the government might furnish initial startup refrigerators and freezers. The Contractor shall maintain this equipment and provide appropriate backup and security in case of equipment failures. The Contractor shall also furnish their own laboratory facilities and equipment for conducting specific laboratory assays or alternatively identify and select reference laboratories with relevant expertise. CAPABILITY STATEMENT Interested small businesses should submit information regarding their: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; (e) examples of prior completed Government contracts or grants, references, and other related information; and (d) respondents’ DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc.) pursuant to the applicable NAICS code. Capability statements shall be submitted in Adobe pdf or MS Word format and not exceed 20 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space using 12-point font size. Capability Statements must be submitted electronically by January 27, 2012, 3:00 PM, EST to the email address of the Primary Point of Contact listed below. All responses received by the specified date and time will be acknowledged by the Primary Point of Contact listed below. DISCLAIMER AND IMPORTANT NOTICES This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any small business responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a future solicitation. CONFIDENTIALITY No proprietary, classified, confidential, or sensitive information should be included in a respondent’s response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). Small businesses that believe they possess the necessary capabilities to meet these requirements are encouraged to contact the Primary Point of Contact listed above.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIEHS/NIHES2012138/listing.html)
- Place of Performance
- Address: Research Triangle Park, North Carolina, 27709, United States
- Zip Code: 27709
- Zip Code: 27709
- Record
- SN02654054-W 20120114/120112235022-64ad3ef4feb24105f6cb3da73d411bed (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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