SOURCES SOUGHT
A -- Aldosterone Antagonists for the Treatment of Heart Failure with Preserved Systolic Function
- Notice Date
- 5/14/2003
- Notice Type
- Sources Sought
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Institute, Contracts Operations Branch 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, MD, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- Reference-Number-ss-hc-19
- Response Due
- 6/3/2003
- Archive Date
- 6/18/2003
- Point of Contact
- Lisa O'Neill, Contracting Officer, Phone (301) 435-0345, Fax (301) 480-3430,
- E-Mail Address
-
lo17f@nih.gov
- Description
- The National Heart, Lung, and Blood Institute is conducting a market survey to assess the availability and potential technical capability of small business firms as defined by NAICS Code 541710, to perform as a Clinical Trials Coordinating Center for a large multicenter clinical trial. The purpose of the trial is to evaluate the effectiveness of aldosterone antagonist therapy in reducing all cause mortality in patients who have heart failure with preserved systolic function. The research study proposed includes 5,000 patients, and is a double blinded, randomized, placebo controlled trial. In addition, the Clinical Trials Coordinating Center will manage a echocardiography and tonometry core laboratory that will analyze serial studies to examine the effect of treatment on ventricular and vascular remodeling, changes in indices of systolic and diastolic function, vascular compliance and ventricular-vascular coupling; and 2) a pharmacogenetics component that will collect and store blood and urine for both immediate and future studies of biomarkers of disease severity and progression as well as response to treatment. Capability statements furnished should demonstrate: (1) professional qualifications of scientists and technical personnel including medical, technical, scientific, statistical, and administrative staff with relevant expertise in clinical trials research; (2) the organizational flexibility to modify the labor mix to meet the changing demand on the resources; (3) evidence of prior administrative and scientific leadership as a Clinical Trials Coordinating Center and managing a clinical trial for cardiovascular disease similar to the size of this trial (5,000 patients); (4) evidence of prior experience in developing a suitable approach to protocol development and implementation for a similar study, including assessing and overseeing clinical investigators with the ability to enroll and follow adequate numbers of patients including women and minorities; (5) access to a large capacity computer facility and networking to remote terminals, (6) evidence of publishing scientific papers and the current availability of expert staff to publish such papers; (7) the firm?s status as a small business under NAICS Code 541710. This is not a Request for Proposal (RFP). Please provide three (3) copies of your capability statement within fifteen (15) calendar days from the date of this publication.
- Record
- SN00323803-W 20030516/030514213258 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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