SOLICITATION NOTICE
A -- Assessments and Assistance for NIAMS Clinical Studies
- Notice Date
- 10/20/2010
- Notice Type
- Presolicitation
- 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 Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-AR-11-30
- Archive Date
- 11/19/2010
- Point of Contact
- Tara Knox, Phone: 301-402-0834, Marianne DiSomma, Phone: 301-435-0369
- E-Mail Address
-
knoxt@nhlbi.nih.gov, marianne.disomma@nih.gov
(knoxt@nhlbi.nih.gov, marianne.disomma@nih.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- The National Heart, Lung, and Blood Institute on behalf of The National Institute of Arthritis, Musculoskeletal, and Skin Diseases (NIAMS) is seeking an organization who will provide executive secretarial/logistical support for the management of committees providing data and safety monitoring oversight to NIAMS funded clinical studies/trials and assessment and assistance with the conduct of clinical research to ensure data quality and adherence to good clinical practice, and Federal guidelines and policies. The NIAMS has oversight of over 60 clinical trials and several large scale epidemiological/observational studies and biospecimens repositories. Areas of funded research include broadly arthritis, musculoskeletal, and skin diseases and other related diseases/conditions that are in the NIAMS mission areas. Clinical studies can be funded using various award mechanisms (i.e., cooperative agreements, grants and contracts) and could range in size (e.g., 10 to 5,000 participants), the scientific complexity, and the research methodology and study design. Additionally, risk to human subjects is an important factor in evaluating the oversight needed for the studies in the Institute’s clinical research portfolio, as it determines the type of data and safety monitoring body needed to assure that the safety and well-being of participants are being carefully monitored, and there is confidence in the quality and integrity of the results that are produced by these important studies. The Division of Extramural Research Activities (DERA) within the NIAMS Extramural Program (EP) is responsible for the administration and coordination of clinical research policies and guidelines for the oversight of clinical research, including establishing study monitoring committees for clinical trials. It is anticipated that technical support will entail such things as: (1) Logistical and executive secretarial support for data safety monitoring boards (DSMBs and OSMBs), Scientific Advisory Committees and Steering Committees; (2) Data quality assurance/quality control of clinical studies; (3) Assistance in the conduct of clinical trials; (4) Guidance on data safety and monitoring plans including guidance on protocol (MOOP) development; (5) Training in the conduct of clinical trials; (6) Consultation with program staff on policies and procedures related to clinical studies; (7) Biostatistical support; (8) Guidelines for clinical research; (9) Providing support for data management resources and services for clinical studies including: recruitment strategy review and consultation; and review of statistical plans and analysis of approaches to studies; (10) Development and maintenance of on-line tools including Tracking Tool Database; Secure Website for DSMB and other meetings information; Clinical Studies Database; and (11) Maintain and monitor Serious Adverse Events (SAE) and Adverse Events (AE) reports for selected studies. It is anticipated that one cost plus award fee contract award will be made for a period of five years beginning on or about September 1, 2011. The solicitation will be available electronically on or about November 5, 2010 and may be accessed through the Internet at the following address: http://www.fedbizopps.gov. under the National Heart Lung and Blood posting section. Proposals will be due on or about January 4, 2011. Offerors are responsible for downloading their own copy of the solicitation and amendments and for routinely checking the Internet site for any possible solicitation amendments that may be issued by the Government. This advertisement does not commit the Government to award a contract.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-AR-11-30/listing.html)
- Place of Performance
- Address: Contractor Site, United States
- Record
- SN02313944-W 20101022/101020234025-1b2d7dd522ca601073fc8bd932ef5c78 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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