SOLICITATION NOTICE
B -- Consultant Services
- Notice Date
- 1/6/2009
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-PB-DE-2009-064-KLW
- Archive Date
- 1/30/2009
- Point of Contact
- Kesha L. Williams,, Phone: 301-435-2605, Kathleen J. Marsden,, Phone: (301) 435-0364
- E-Mail Address
-
williamk@nhlbi.nih.gov, km66x@nih.gov
- Small Business Set-Aside
- N/A
- Description
- THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR A PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. It is the intent of the National Heart, Lung, and Blood Institute to issue a purchase order on a noncompetitive basis to Omnicare Clinical Research, Inc 630 Allendale Rd, King of Prussia, PA 19406-1418 for Expert Clinical Associate to provide Clinical Trial Reviews. The vendor will provide a person with expertise in the monitoring of clinical trials that includes: •ability to maintain patient confidentiality as well as confidentiality of all associated data. •ability to read, interpret and understand clinical protocols. •understanding of, and experience with, the conduct of Clinical Trials and their monitoring in accordance with Good Clinical Practices and Human Subject Protection regulations. •understanding of the requirements for Clinical Trial performance and management in accordance with Good Clinical Practices and Human Subjects Protections. •Prior to beginning any monitoring activities, completion of appropriate NIH forms, including Contractor Employee Non-Disclosure Agreement and the NIH forms for obtaining access to the patient charts and records through the NIH Clinical Center •evaluate if clinical trials were conducted in accordance with the protocol and identify protocol deviations. •review subject records and identify adverse events •prepare a summary document for review by the medical consultant, NIDCR IRB, an NIDCR medical consultant and Office of Scientific Director staff to include: timeline for the evaluation of testing and interventions performed on the subjects as specified in the protocol, noting any protocol deviations; a summary of all related clinical data; and a listing of adverse events The sole source determination is based upon the fact that this vendor is already performing these services under a current purchase order, and at this time requires additional hours and funding to complete the SOW as outlined. In an effort to maintain consistency of the data analysis being conducted it is necessary to maintain work with the current vendor. This will allow NIH to benefit from the investment already made. The North American Industry Classification (NAICS) Code is 541711 and the Size Standard is $6.5M. The acquisition is being conducted under FAR Part 13, Simplified Acquisition Procedures, and is exempt from the requirements of FAR part 6, Competition Requirements. This notice of intent is not a request for competitive proposals. Interested parties may identify their interest and capabilities in response to this notice. All responses should include a firm fixed price; documentation of the capabilities of meeting the government requirements; at least three references documenting successful past performance in meeting Government minimum specifications; a proposed delivery schedule; prompt payment discount terms; the DUN & Bradstreet number (DUNS); the Taxpayer Identification Number (TIN); and the offeror’s business size. The submission will be evaluated on the content of the above documents. The offeror must also register in the Government’s Contractor Registry System, Note: www.ccr.gov. The determination by the Government not to compete the proposed contract based upon responses to this notice is solely with the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct future competitive procurements. Comments to this announcement, referencing synopsis number NHLBI-PB-DE-2009-064-KLW may be submitted by mail to the National Heart Lung, and Blood Institute, Procurement Branch, 6701 Rockledge Drive, Suite 6042, Bethesda, MD 20892-7902, Attention: Kesha Williams, by fax transmission to (301) 480-3345 or by email to williamk@nhlbi.nih.gov all responsible sources may submit information, which if received timely, shall be considered by the agency.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=caad14cb8ae669d2f9a8b4e9b9c4cab4&tab=core&_cview=1)
- Place of Performance
- Address: Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN01727664-W 20090108/090106220810-caad14cb8ae669d2f9a8b4e9b9c4cab4 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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