A -- Assessment and Assistance for NIAMS Clinical Studies

The National Heart Lung and Blood Institute on behalf of the National Institute of Arthritis and Musculoskeletal and Skin Diseases 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) logistical and executive secretarial support for data safety monitoring boards (DSMBs and OSMBs), Scientific Advisory Committees and Steering Committees; (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 support; (9) guidelines for clinical research; (10) providing support for data management resources and services for clinical studies including: recruitment strategy review and consultation; and review of statistical plans and analysis of approaches to 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 - 5,000 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 541710, Size Standard - 500 employees. It is anticipated that one cost reimbursement contract award will be made for a period of five years beginning on or about September 1, 2006. The incumbent contractor is Kunitz and Associates, Inc. The solicitation, NIH-NIAMS-06-01, will be available electronically on or about January 6, 2006 and may be accessed through the Internet at the following address: http://www.fedbizopps.gov. under the National Heart Lung and Blood posting section. Proposals will be due on or about February 22, 2006. 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.*****