AN24-- Good Clinical Practice (GCP) Clinical Research Quality Associate (CRQA) Monitoring Services

Solicitation 36C24E26Q0054 is a combined synopsis and solicitation issued by the Department of Veterans Affairs, Regional Procurement Office East, for Good Clinical Practice (GCP) Clinical Research Quality Associate (CRQA) Monitoring Services. This contract is set aside for Service-Disabled Veteran-Owned Small Businesses (SDVOSB) under NAICS code 541990. The estimated contract value ranges from a minimum of 20,000 dollars to a maximum of 2,000,000 dollars, with a total period of performance of three years, typically spanning from September 16, 2026, to September 15, 2029. The scope of work involves providing CRQA monitoring services, including site visits and non-conformance reporting, adhering to strict regulatory standards such as ICH E6 (R2), 45 CFR 46, 38 CFR 16, and various FDA and VHA directives. Contractor personnel must meet rigorous qualification standards, including a bachelor's degree in a scientific or health-related field or professional licensure, GCP training, and a minimum of 10 years of relevant experience. Security requirements include background investigations ranging from Tier 1 to Tier 5 depending on the risk level of the duties. Proposals must be submitted via email to the Contracting Officer, Renee Kale, by August 25, 2026, at 10:00 AM EDT. Submissions must be organized into separate, clearly labeled electronic files across six specific sections, including technical, price, and past performance volumes, with strict page limits for technical narratives and past performance references. Invoicing must be processed electronically through the VA Electronic Invoice Presentment and Payment (EIPP) System.