SOLICITATION NOTICE
A -- Clinical Research Support Services
- Notice Date
- 12/21/2004
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Environmental Health Sciences, Research Contracts Branch, DERT P.O. Box 12874, 79 T.W. Alexander Dr, Bldg 4401, RTP, NC, 27709
- ZIP Code
- 27709
- Solicitation Number
- NIH-ES-05-02
- Response Due
- 3/1/2005
- Archive Date
- 3/16/2005
- Description
- The National Institute of Environmental Health Science (NIEHS) is seeking offers to provide support to Principal Investigators (PIs) in the Office of Clinical Research (OCR) and Division of Intramural Research (DIR) at the NIEHS for various types of clinical research studies and interventional clinical trials. Examples of observational studies to be covered by this contract are case report and case series, case-control, cross-sectional, and prospective and retrospective cohort studies. Interventional studies to be covered by this contract are: 1) efficacy trials of new treatments, new combinations of drugs, new approaches to surgery or radiation therapy; 2) prevention trials 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; and 4) 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. Observational and interventional clinical research involves carrying out many complex study tasks, all of which will be supported by this contract. The design and implementation of each clinical research projects will be the responsibility of the Task Leader initiating the study, but advice may be sought from the NIEHS Project Officers, Contractor or a contracted panel of experts. The extent of the Contractor's involvement with any given study may vary depending on the study design and support available in-house, through collaborators or other contracts. For example, the Contractor might carry out only the surveillance and recruitment phase of a study, or only develop and administer study questionnaires. Alternatively, the Contractor might only be involved in the treatment or sample collection phase of a study. Some studies will require medical support for the initial subject evaluation, diagnoses, treatments, and follow-up care and this will involve providing medical personnel and facilities and/or interacting with medical personnel at other facilities including physician?s practices, clinics, and hospitals. The medical institutions may be local or distant, and thus require travel by Contract personnel and/or study participants. The Contractor might be required to coordinate activities with various reference laboratories, medical clinics or other institutions, and collaborators with NIEHS personnel. Finally, all studies and/or tasks supported by this contract will be conducted according to all relevant federal guidelines and regulations. Therefore, the Contractor will have knowledge and experience of all relevant guidelines and regulations for using human beings in research studies, e.g. 45 CFR 46 or the DHHS Common Rule, and those regulations for patient confidentiality such as the Health Insurance Portability and Accountability Act of 1966 (HIPAA). It is anticipated that a contract will be awarded with a base period of performance of four years with options to extend the period of performance up to a total of ten years. Also, the solicitation will include, along with other evaluation criteria, a mandatory qualification criteria that must be met that is geographic restriction that the offeror(s) shall for the duration of the period of performance have existing or demonstrate ability to establish offices, equipment and technical facilities, including laboratory facilities within 30 minutes driving time of the NIEHS, Research Triangle Park, NC 27709. Established offices and facilities must occur within 60 days of contract award. Frequent discussions and consultations with NIEHS Project Officer necessitate that the Contractor be in close proximity to minimize the expense to the Government and increase communications. The anticipated release date of the solicitation is sometime during the 2nd and 3rd week of January 2005. The NAICS code is 541710. See Numbered Note 26.
- Record
- SN00724390-W 20041223/041221211755 (fbodaily.com)
- Source
-
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