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 4 one year options for renewal. The minimum annual contract guarantee is $10,000.00. Contract award will be based on best value to the Government. A technical proposal and price proposal will be required from all offerors. Factors to be considered are Experience, Past Performance, Technical Abilities and Price. To be eligible for contract award, the contractor must have: at least 5 years of experience in GCP Quality Assurance services to clinical research organizations; one year experience in GCP Quality Assurance services in federally-funded research that includes actual experience monitoring or auditing VA research sites. Contractor must be: certified as a Clinical Research Associate (CRA) by the Association of Clinical Research Professions (ACRP) or an equivalent certifying body; certified or eligible to take PRIMR/ARENA examination for certification in Human Subjects Protections. Additionally, contractor must have a minimum of a Bachelor's Degree in Science or Nursing or a graduate degree in a related field, or be a Registered Nurse, Pharmacist, physician or other licensure as a health-care provider. Also, the contractor must have computer knowledge in Power Point, Word and Excel; completed GCP training; and be capable of responding to emergent situations. This procurement is 100% set-aside for Small Business. The NAICS Code is 541611, with a size standard of $6.5 million. THE ISSUE DATE FOR THIS SOLICITATION IS TO BE DETERMINED. This solicitation is available by downloading it from FedBizOpps (www.fedbizopps.gov). Hard copies of the solicitation will not be available. The site provides downloading instructions. All future information regarding this acquisition, including solicitation amendments, will also be distributed solely through this site. Interested parties are responsible for monitoring this site to ensure that they have the most up-to-date information about this acquisition. All contractors doing business with the Federal Government shall be registered in the Central Contractor Registration (CCR) database. The web site for registration is www.ccr.gov.