Loren Data's SAM Daily™

FBO DAILY ISSUE OF SEPTEMBER 22, 2005 FBO #1396
SOURCES SOUGHT

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

Notice Date

9/20/2005
 

Notice Type

Sources Sought
 

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
 

Response Due

9/14/2005
 

Archive Date

10/20/2005
 

Point of Contact

Richard Phillips, Contract Specialist, 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 Division of Blood Diseases and Resources of the National Heart, Lung, and Blood Institute is conducting a market survey to assess the availability and potential technical capability of small business firms to perform as the Clinical Data Coordinating Center for the project entitled: Phase II/III Clinical Trial of Sildenafil for Sickle Cell Disease-Associated Pulmonary Hypertension (PH). The applicable NAICS code is 541710 and the size is 500 employees. The purpose of the study is 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 PH and Sickle Cell Disease (SCD). It is anticipated that up to twelve clinical sites will be awarded under a separate RFP. The Clinical Data Coordinating Center will have overall responsibility for the operation of the clinical trial 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 center 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 (AISSP) Handbook found at this location: http://irm.cit.nih.gov/policy/aissp.html. Small business firms having demonstrated experience in performing tasks 1-10 above are invited to submit capability statements (original and three copies). Capability statements must provide evidence of experience in performing the tasks described above and demonstrate the following: 1) Qualifications and availability of personnel with experience pertinent to the management and operation of a multi-center clinical trial for sickle cell disease, including expertise in drug distribution, tracking of adverse events, data collection and monitoring, standardization, quality control, data analysis, and preparation of scientific reports; 2) Adequacy of the organizational and administrative structure to participate in a multi-center randomized clinical trial, both in the collection of data from multiple clinical sites as well as experience in monitoring the quality and timeliness of data; 3) Facilities, equipment and resources necessary for the performance of the requirements listed above; 4) The firm?s status as a small business under NAICS code 541710. Capability statements in response to this market survey that do not provide sufficient information for evaluation will not be considered. This is NOT a Request for Proposals (RFP), and responses should not include budgetary information. The RFP release date is pending. The government intends to negotiate one contract for a period of four years with an approximate award date of September 30, 2006. Firms responding to this market survey should provide information pertinent to the requirements mentioned above within (15) calendar days from the date of this announcement to the address shown above.
 

Place of Performance

Address: NIH/NHLBI, 6701 Rockledge Drive, Rockledge 2/Room 6132, Bethesda, Maryland 20892-7902

Zip Code: 20892-7902

Country: United States
 

Record

SN00899227-W 20050922/050920211712 (fbodaily.com)
 

Source

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

---

| FSG Index  |  This Issue's Index  |  Today's FBO Daily Index Page |