R--Auditing/QA Services for VA Cooperative Studies

The New Mexico VA Health Care System (NMVAHCS) intends to procure an Indefinite Delivery Indefinite Quantity contract for Good Clinical Practice (GCP) Quality Assurance Services for the clinical trials conducted by the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (VA CSPCRPCC), located in Albuquerque, New Mexico. These trials are conducted at VA facilities and associated non-VA facilities throughout the USA, Canada and the United Kingdom. The clinical trials vary over time in number, size and design, but typically consist of 25 trials conducted at 300 to 400 investigative sites. The purpose of this contract is to acquire the following services: Provide Good Clinical Practice (GCP) training to VA Researchers and Cooperative Studies Program (CSP) Site Monitors; Conduct GCP quality assurance audits (Site and Sponsor Audits); Develop tools, worksheets and GCP guidance for each new CSP trial; Provide advice and support for CSP program and policy development; Plan and manage GCP implementation program for selected CSP trials; Provide oversight for new studies. The contract requires a significant amount of travel. Task orders will be issued against the established contract for required services. It is anticipated that up to 3 awards may be made. The period of performance is for a base year with 2 one year options for renewal. Issue date will be approximately October 1, 2008. Request for solicitation package must be in writing via e-mail (michael.essex4@va.gov), on company letterhead faxed to 505-256-2894, Attn: Michael Essex. or mail requests to New Mexico VA Health Care System Attn: Michael Essex (501/90C) (Bldg. #46), 1501 San Pedro SE, Albuquerque, NM 87108. This procurement is 100% set-aside for Small Business. The NAICS Code is 541611, with a size standard of $7.0 million. Subject to the availability of funds.