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FBO DAILY ISSUE OF OCTOBER 29, 2005 FBO #1433
SOLICITATION NOTICE

A -- Phase II/III Trial of Sildenafil for Sickle Cell Disease-Associated Pulmonary Hypertension – Data Coordinating Center

Notice Date

9/20/2005
 

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 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

NIH-NHLBI-HB-06-04
 

Point of Contact

Richard Phillips, Contracting Officer, Phone 301-402-6462, Fax 301-480-3432, - Joanna Magginas, Contracting Officer, Phone (301) 435-0355, Fax (301) 480-3432,
 

E-Mail Address

rp235k@nih.gov, jb532r@nih.gov
 

Small Business Set-Aside

Total Small Business
 

Description

The NHLBI has a requirement for a study to test the effects of 16 weeks of chronic sildenafil therapy on exercise endurance and pulmonary artery pressure in 180 patients (aged 14 and up) with pulmonary hypertension (PH) and Sickle Cell Disease (SCD). The proposed procurement is under a 100 percent small business set-aside, and the NAICS code is 541710. The successful offeror will operate as a Data Coordinating Center (DCC) for this clinical trial. The DCC shall be capable of conducting all aspects of a multi-center clinical trial for the treatment of PH in patients with SCD using sildenafil and will be responsible for performing the following tasks: 1) Collect data from up to 12 clinical sites capable of recruiting study subjects; 2) Prepare statistical reports as needed to monitor study progress, quality of data, and clinical site performance; 3) Participate in the finalization of the study protocol and Manual of Procedures and train study personnel on study procedures; 4) Develop and distribute Case Report Forms to all clinical sites; 5) Oversee a Pharmacy Distribution Center and develop a system for random assignment to each treatment arm for each patient enrolled in the trial; 6) Implement a process for communicating random assignments to the individual clinical sites; 7) Perform data analyses of all study data; 8) Provide coordination and leadership in the resolution of operational problems for the entire study; 9) Develop plans for either secure web-based electronic data entry, or paper data entry, by clinical sites; and 10) Comply with the DHHS Automated Information Systems Security Program Handbook found at this location: http://irm.cit.nih.gov/policy/aissp.html . The government intends to negotiate one cost reimbursement type contract for a period of four years with an approximate award date of September 30, 2006. It is anticipated that up to twelve clinical sites will be awarded under a separate Request For Proposals (RFP). This is not a RFP. RFP NHLBI-HB-06-04 will be available on or about October 5, 2005, and may be accessed at the following URL location: http://www.nhlbi.nih.gov/funding/inits/index.htm#rfp and posted on Fed Biz Opps at http://fedbizopps.gov . No paper copies will be available. Original Point of Contract Rick Phillips, Contracting Officer, Phone (301) 402-6462, Fax (301) 480-3432, E-mail phillipr@nhlbi.nih.gov or Joanna Magginas, Chief, BDR Contracts Section, Phone (301) 435-0355, Fax (301) 480-3432, E-mail magginaj@nhlbi.nih.gov NOTE: THIS NOTICE MAY HAVE POSTED ON WWW.FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (20-SEP-2005). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 27-OCT-2005, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
 

Web Link

Link to FedBizOpps document.
(http://www.fbo.gov/spg/HHS/NIH/NHLBI/NIH-NHLBI-HB-06-04/listing.html)
 

Place of Performance

Address: 6701 Rockledge Drive Rockledge II/Room 6132 Bethesda, Maryland 20892-7902

Zip Code: 20892-7902

Country: United States
 

Record

SN00922688-F 20051029/051027213606 (fbodaily.com)
 

Source

FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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