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FBO DAILY ISSUE OF SEPTEMBER 24, 2011 FBO #3591
DOCUMENT

A -- VA Clinical Trial Study Ralph H. Johnson VA Medical Center September 30, 2011 through September 29, 2012 (One Option Year) - Attachment

Notice Date

9/22/2011
 

Notice Type

Attachment
 

NAICS

622110 — General Medical and Surgical Hospitals
 

Contracting Office

Department of Veterans Affairs;VISN 7 Network Contracting Activity;501 Greene Street;Hatcher Building - Suite 2;Augusta GA 30901
 

ZIP Code

30901
 

Solicitation Number

VA24711RP0504
 

Response Due

9/28/2011
 

Archive Date

11/27/2011
 

Point of Contact

Brad D. Nelson
 

E-Mail Address

elson@va.gov<br
 

Small Business Set-Aside

Partial Small Business
 

Description

SYNOPSIS This is a SOURCES SOUGHT announcement only. The Department of Veterans Affairs is conducting a MARKET SURVEY to obtain information from qualified businesses, with special interest in seeking: Service Disabled Veteran Owned Businesses (SDVOSB), Veteran Owned Small Businesses (VOSB), and Small Business Concerns. Your responses to the information requested will assist the Government in determining the appropriate acquisition method. No solicitation is being issued at this time. This notice shall not be construed as a commitment by the Government to ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. All information submitted in response to this announcement is voluntary; the Government will not pay for information requested nor will it compensate any respondent for any incurred in developing information provided to the Government. DESCRIPTION OF THE REQUIREMEMT The Ralph H. Johnson VA Medical Center located at 109 Bee Street, #300, Charleston, South Carolina 29401 anticipates a requirement for a clinical trial aimed at determining whether a daily supplementation of Vitamin D3 at 4,000 international units (IU) for one year will benefit patients who elect to be monitored through active surveillance of their early-stage prostate cancer. The NAICS code is 622110. The Contractor shall provide expertise, facilities, identification, enrollment, treatment, and monitoring of study subjects to accomplish the following: 1.Identify eligible patients with early-stage prostate cancer and enroll them in the clinical study. All personnel involved in the informed consent process must undergone training in research involving human subjects, through the Ralph H. Johnson VA Medical Center in Charleston. 2.Randomize subjects to the treatment or placebo arm of the trial, as needed. Best-practices randomization procedures will be applied as described in the original study design. 3.Dispense the study drug. This will be accomplished in strict coordination with the VA pharmacist. 4.Verify compliance of enrolled subjects. This will be accomplished through standard practices (e.g., counting of pills) as well as by carefully reviewing case report forms (CRF) to ensure that all relevant data for compliance and later analysis are captured. 5.Perform blood tests and other required tests on the subjects. The PI will oversee all data collection involved in the study. 6.Monitor the subjects for the entire duration of the trial. Particular attention will be given to monitoring any adverse events related to the study, including any signs of toxicity associated with the study drug. 7.Verify quality assurance at the site. Contractor will provide the PI with all necessary information to fulfill regulatory mandates, in order to satisfy the requirements of the Data Safety Monitoring Board (DSMB). 8.Enhance patient health education. This will be accomplished by providing study subjects with food frequency questionnaires and counseling them on best health practices. 9.Provide the outcomes of the study to the PI and data manager for all enrolled subjects. 10.Analyze clinical, chemical, and biochemical data. This will be accomplished by monitoring on a regular basis with the data manager the appropriate collection of data and transfer to the biostatistician for interim analysis. POTENTIAL SOURCES SHALL PROVIDE THE FOLLOWING INFORMATION IN THEIR RESPONSE: 1) Company name, address, phone number, primary contact(s), e-mail address, NAICS code(s), business size (i.e., small/large) and DUNS Number. 2) Provide a Statement of Capability that demonstrates the offeror's past performance in providing this type of service. 3) Submit Capability Statements via email to brad.nelson@va.gov by September 26, 2011. Responses should be received no later than 12:00 PM EST. NO CAPABILITY STATEMENTS MAY BE SUBMITTED AFTER SEPTEMBER 26, 2011. AT THIS TIME NO SOLICITATION EXISTS. (DO NOT REQUEST A COPY OF THE SOLICITATION). A FUTURE NOTICE WILL BE POSTED WHEN THE SOLICITATION WILL BE RELEASED. 4) Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. (5) No Proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s.)
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/AuVAMC/VAMCCO80220/VA24711RP0504/listing.html)
 

Document(s)

Attachment
 

File Name: VA-247-11-RP-0504 VA-247-11-RP-0504.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=260977&FileName=VA-247-11-RP-0504-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=260977&FileName=VA-247-11-RP-0504-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: Department of Veterans Affairs;Ralph H. Johnson VA Medical Center;109 Bee Street, #C300;Charleston, South Carolina

Zip Code: 29401
 

Record

SN02589125-W 20110924/110923000548-9b19512f4a3350f76d410dac8171c086 (fbodaily.com)
 

Source

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

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