SOURCES SOUGHT
A -- Assessment and Assistance for NIAMS Clinical Studies
- Notice Date
- 11/25/2005
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Institute, Office of Acquisitions 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, MD, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NIH-NIAMS-06-01
- Response Due
- 12/12/2005
- Point of Contact
- Lisa Hill, Contracting Officer, Phone 301-594-2543, Fax 301-480-5996, - Joanna Magginas, Chief, BDR/NIAMS Branch, Phone (301) 435-0355, Fax (301) 480-3432,
- E-Mail Address
-
lh314r@nih.gov, jb532r@nih.gov
- Small Business Set-Aside
- Total Small Business
- Description
- The National Heart Lung and Blood Institute on behalf of the National Institute of Arthritis and Musculoskeletal and Skin Diseases is conducting a market survey to assess the availability and potential technical capability of small business firms to perform technical support for the Extramural Program clinical research activities (clinical trials, registries, observational studies, etc.). The applicable NAICS code is 541990. NIAMS conducts clinical research through various mechanisms: grants, cooperative agreements and contracts. Areas of research include arthritis, skin diseases, musculoskeletal diseases, osteoporosis, and other diseases/conditions that are in the NIAMS mission. Research activities include clinical studies (observational, epidemiological, and longitudinal studies as well as Phase I, II, and III clinical trials). It is anticipated that technical support will entail such things as: (1) data safety monitoring boards (DSMBs and OSMBs), Scientific Advisory Committees and Steering Committees, logistical and executive secretarial support; (2) data quality assurance/quality control of clinical studies; (3) assistance in the conduct of clinical trials; (4) prepare OMB clearance documents; (5) guidance on data safety and monitoring plans including guidance on protocol (MOOP) development; (6) training in the conduct of clinical trials; (7) consultation with program staff on policies and procedures related to clinical studies; (8) biostatistical and epidemiological support; (9) guidelines for clinical research; (10) providing support for data management resources and services for clinical studies including: recruitment strategy review and consultation; review of statistical plans and analysis of approaches to epidemiological studies; (11) development and maintenance of on-line tools including Tracking Tool Database; Secure Website for DSMB and other meetings information; Clinical Studies Database; and (12) maintain and monitor Serious Adverse Events (SAE) and Adverse Events (AE) reports for selected studies. NIAMS is currently supporting approximately 273 clinical studies and 60 clinical trials ranging in size from 10 to 1,500 participants as well as several large scale (500 – 5000 participants) observational studies. Small Businesses having demonstrated experience in performing the tasks above are invited to submit Capability Statements (original and 3 copies) to Contracting Officer, BDR/NIAMS Contracts Branch, 6701 Democracy Blvd., Suite 800, MSC 4872, Bethesda, Maryland 20892 (20817 for overnight delivery). Capability Statements must demonstrate qualified available personnel with the pertinent experience, adequate organizational and administrative structure, submission of quality timely data, and demonstration of the facilities, equipment and resources necessary to perform the work. Additionally, firms must be able to meet the mandatory qualification requirement of being able to attend meetings at the NIH in Bethesda, Maryland within 2 hours of notification of the required meeting. Contractors must also have the ability to comply with the DHHS Automated Information Systems Security Program (the compliance handbook is located at http://intranet.hhs.gov/infosec/docs/policies_guides/ISPPH/PG_ISPolicyv2_12_15_2004.doc. This acquisition is a 100% Small Business Set-Aside. The North American Industry Classification System (NAICS) Code is 541990 for Professional, Scientific, and Technical Services (All Others), Size Standard - $5 million. Capability Statements in response to this market survey that do not provide sufficient information will not be considered. This is NOT a Request for Proposals (RFP) and responses should not include budgetary information. Firms responding to this market survey should provide information pertinent to the requirements above within 15 calendar days from the date of this announcement to the address shown above. It is anticipated that one cost reimbursement contract award will be made for a period of five years beginning on or about July 1, 2006. The RFP release date is pending but will be available electronically at the FedBizOpps Website: http://www.fedbizopps.gov at a later date. This advertisement does not commit the Government to award a contract. Point of Contact: Lisa Hill, Contracting Officer, Phone 301-594-2543, FAX 301-480-5996, Email hilll1@mail.nih.gov – Joanna Magginas, Chief, BDR/NIAMS Contracts Branch (301) 435-0355, FAX 301-480-5996, Email magginaj@mail.nih.gov NOTE: THIS NOTICE MAY HAVE POSTED ON FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (25-NOV-2005). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 30-AUG-2006, 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-NIAMS-06-01/listing.html)
- Record
- SN01130826-F 20060901/060830224616 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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