Clincial Research Support Services for NIEHS

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; 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) conducts or oversees clinical research studies within the Division of Intramural Research (DIR), National Institute of Environmental Health Sciences (NIEHS). The objectives of these studies are to: 1) translate basic laboratory findings to clinical applications; 2) investigate the interaction between genetic susceptibility and environmental factors as they relate to complex traits and disease in human populations; and 3) intervene in disease development and/or progression by modifying these factors using preventative, therapeutic, and other techniques, or by altering environmental exposures, diet and lifestyles. In addition, the NIEHS conducts research on the potential health effects following natural disasters, such as the GuLF Study, a large prospective health study of oil spill clean-up workers and volunteers following the Deepwater Horizon Disaster. NIEHS also collects time-critical exposure and health information to address a wide variety of research questions about the health impacts of both natural (e.g., hurricanes, floods, drought and other severe weather events) and man-made disasters (e.g., chemical spills, terrorist incidents). PURPOSE AND OBJECTIVES The NIEHS seeks capability statements from qualified small businesses to provide medical, diagnostic, therapeutic, scientific, technical, data management, managerial, clerical, and statistical support to Principal Investigators (PIs) within the DIR, NIEHS and their collaborators. The Contractor shall assist the Government by identifying and enrolling subjects, and administering, managing, and conducting clinical studies designed and conducted by PIs alone or in collaboration with other scientists inside or outside of the NIEHS. Another purpose of this contract is to provide technical expertise and health care staff to the NIEHS Clinical Research Unit (CRU) in support of clinical studies conducted in that facility. The Contractor shall provide technical expertise and various staff members to the NIEHS Clinical Research staff in support of its clinical studies conducted at the National Institutes of Health in their Clinical Center in Bethesda, Maryland. These staff will include research nurses, study coordinators, and other support personnel. The Contractor shall function in a purely supportive role carrying out specific task orders, and shall not engage in independent research under this contract. The Contractor shall provide field research support to the NIEHS in response to natural or man-made environmental disasters, or community outreach research. Thus, the NIEHS Clinical Support Services contractor must have the resources to begin work at a short notice, the logistical ability to implement NIEHS research in a national scale, and the expertise to perform large-scale field research as well as in-house clinical research. PROJECT REQUIREMENTS Contractors must demonstrate their ability to meet all project requirements (1) through (16) below by succinctly describing their own in-house capabilities and/or those of any proposed partners/subcontractors. The requirements are: (1) Provide expertise on, complete, and submit study design and planning for a wide array of single or multi-center clinical studies and/or assist in the implementation of new clinical studies based on study designs provided by NIEHS Scientific Investigators. (2) Draft, submit for review and finalize 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 study populations either locally, nationally and/or internationally on short notice. For example, rapid response studies in the aftermath of a natural or man-made disaster (e.g. Hurricane Katrina, Gulf oil spill) need to be on site within days of the disaster. (4) Administer treatments, conduct examinations, and/or implement interventions in study subjects. (5) Conduct diagnostic assessments or provide medical care to study subjects on an in-patient and/or out-patient basis by providing medical personnel and facilities and/or interacting with medical personnel at other local or distant facilities including physicians' practices, clinics, hospitals and other research centers. (6) Collect data and biologic materials from study subjects and coordinate data capture activities with various reference laboratories, medical clinics or other institutions. (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. The Contractor shall furnish laboratory facilities and equipment for conducting specific laboratory assays or alternatively identify and select reference laboratories with relevant expertise. (9) Develop study databases including the recording and summarizing of data and provide programming support for data analysis, perform scientific review and oversight, and conduct study management and analyses. (10) Statistically analyze study data sets and develop reports, graphics, presentations and share in 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) Submit and implement a Quality Control or Quality Assurance Plan for individual studies. (14) Provide operational support (study coordinators, physicians, nurses, therapists, technicians, administrative and other types of personnel) and IT support (electronic patient registration and data management) for the NIEHS Clinical Research Unit (CRU) in RTP, NC and for certain NIEHS studies in the NIH Clinical Center (CC), Bethesda, MD. The CRU is an outpatient clinic on the NIEHS campus which sees up to 100 subjects per week. The CC is the nations' largest clinical research unit with inpatient, out-patient and day hospital services. Staffing might be required full-time, part-time or be intermittent depending on the needs of the CRU and other facilities and the needs for individual studies. The Contractor shall also provide expertise to the CRU and other facilities for various aspects of running the facilities 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). (15) Provide operational support (study coordinators, physicians, nurses, therapists, technicians, administrative and other types of personnel) and IT support (electronic patient registration and data management) for multi-site or off-site studies. These could be either treatment trials or natural history studies in response to natural or man-made disasters (see point 3), and they may be local, national or international in scope. Rapidity of operational response is paramount. (16) Conduct studies in compliance with pertinent federal guidelines and regulations. The Contractor shall have and maintain up-to-date 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). Prior to contract award, the Contractor shall also have an up-to-date Federal Wide Assurance number issued through the HHS Office of Human Research Protections. ANTICIPATED PERIOD OF PERFORMANCE AND STAFFING The anticipated start date of the award is October 1, 2015. The planned total period of performance is ten (10) years. It is estimated that the total level of effort required is approximately 150,000 direct labor hours per year. GOVERNMENT FURNISHED EQUIPMENT AND MATERIALS The Contractor shall provide space in their facility or in a subcontracted facility for storing frozen and/or refrigerated biospecimens. Such a facility must be in the proximity of RTP so that the Government can have ready access to these samples. In this case, the Government may furnish initial startup refrigerators and freezers. The Contractor shall maintain this equipment and provide appropriate backup and security in case of equipment failures. CAPABILITY STATEMENT Interested small businesses must submit supporting documentation that clearly demonstrates how they and/or their partners are capable of meeting the sixteen Project Requirements described above. Respondents should consider linking each project requirement with a description of their (a) current in-house or partnered capabilities to perform the work as evidenced by a description of staff expertise, experience and training; and (b) a representative list of ongoing or prior completed sponsored studies that are similar to the Project Requirements. Respondents should explicitly list their expertise with multi-site, national and international trials, and their operational plan for establishing a site presence on short notice. Capability statements shall be submitted in Adobe pdf or MS Word format and not exceed 30 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space using 12-point font size. The cover page must indicate the respondent's 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 must be submitted electronically by May 16, 2014, 4:30 PM, EST to the email address of the Primary and Secondary Points of Contact listed below. All responses received by the specified date and time will be acknowledged by one of the Points 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.