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
[email protected] or Joanna Magginas, Chief, BDR Contracts Section, Phone (301) 435-0355, Fax (301) 480-3432, E-mail
[email protected]