R--GCP Monitoring and Reviewing Services

The New Mexico VA Health Care System (NMVAHCS) intends to procure an Indefinite Delivery Indefinite Quantity contract for Good Clinical Practice (GCP) Monitoring and Reviewing 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: Monitoring Visits (with pre and post work) including site initiation monitoring visits, routine monitoring visits at participating sites, close out visits at participating sites, preparing site visit reports and summary letters; Monitoring and Review Visits (without pre and post work), including kickoff meeting/investigator's meeting, support with conducting monitoring visits; GCP Site Initial Review Visits, including training and instructing site personnel on GCP topics and assure proper regulatory information is present in the site files; and GCP Site Reviews. 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 5 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 as a Clinical Research Associate (CRA) monitoring VA and Non-VA sites and experience as an Independent CRA. Contractor must have: a minimum of a Bachelor's Degree in a medical or scientific field with five years or more research monitoring experience, or be a Licensed Health Care Professional with five years or more research monitoring experience. Also, the contractor must have computer knowledge in Power Point, Word and Excel; evidence of Human Subjects training and GCP training and demonstrated knowledge of federal HIPAA and VA privacy regulations. 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.