R -- ASSESSMENT AND ASSISTANCE FOR NIAMS CLINICAL STUDIES

Notice Date

December 20, 2000

Contracting Office

National Institutes of Health, National Institute of Arthritis and Musculoskeletal and Skin Diseases, Natcher Building, Room 5AS-13A, 45 Center Drive, MSC 6500, Bethesda, Maryland 20892-6500

ZIP Code

20892-6500

Solicitation Number

NIH-NIAMS-01-04

Response Due

February 19, 2001

Point of Contact

Shanahan, Elizabeth, Contracting Officer, (301)594-2543

E-Mail Address

Shanahan, Elizabeth (shanahae@mail.nih.gov)

Description

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is seeking an organization to perform technical support to the Extramural Program clinical research activities (clinical trials, registries, observational studies, etc.) 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 board logistical and executive secretarial support; (2) data quality assurance/quality control of clinical studies; (3) assistance in the conduct of clinical trials; (4) guidance on data safety and monitoring plans; (5) training in the conduct of clinical trials;(6) consultation with program staff on policies and procedures related to clinical studies; (7) biostatistical support; and (8) development and revision of guidelines for clinical research. NIAMS currently has approximately 60 clinical trials ranging in size from 10 to 1,500 participants as well as several large scale (500 5000 participants) observational studies. The Request for Proposal will contain a mandatory qualification requirement which is: The contractor must be able to attend meetings at the NIH in Bethesda, Maryland within 2 hours of notification of the required meeting. 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. It is anticipated that one cost reimbursement contract award will be made for a period of five years beginning on or about July 1, 2001. The solicitation, NIH-NIAMS-01-04, will be available electronically on or about January 04, 2001 and may be accessed through the Internet at the following address: http://www.nih.gov/niams/grants/rfp/rfplist.htm. Proposals will be due on or about February 19, 2001. Offerors are responsible for downloading their own copy of the solicitation and amendments and for routinely checking the Internet site for any possible solicitation amendments that may be issued by the Government. This advertisement does not commit the Government to award a contract See Note 1.*****

Web Link

NIH-NIAMS-01-04 (http://www.nih.gov/niams/)

Record

Loren Data Corp. 20001222/RSOL004.HTM (W-355 SN5093V8)