This Sources Sought opportunity from Department Of Veterans Affairs was posted on June 15, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.
AN24--Good Clinical Practice (GCP) Clinical Research Quality Associate (CRQA) Monitoring Services
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The Department of Veterans Affairs, Regional Procurement Office East, is seeking information through a sources sought notice to identify qualified vendors capable of providing Good Clinical Practice (GCP) Clinical Research Quality Associate (CRQA) monitoring services for VA Cooperative Studies Program clinical trials across approximately 300 to 400 U.S. sites. This notice is purely for information and planning purposes, with no solicitation or quote submission being accepted at this time. Respondents must include company name, SAM or DUNS number, address, point of contact details, a detailed capability statement demonstrating experience with GCP monitoring, business size classification as small or large under the $19 million NAICS code 541990, and any applicable socioeconomic certifications such as Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), HUBZone, 8(a), Women Owned, or Small Disadvantaged Business. SDVOSB and VOSB respondents must provide verification from the SBA’s VETCERT database and evidence of compliance with VAAR 852.219-75 regarding limitations on subcontracting. Respondents are encouraged to indicate if they hold existing GSA contract authority. Responses must be submitted via email to Renee Kale at renee.kale@va.gov no later than 10:00 a.m. Eastern Time on June 30, 2026; facsimile and telephone submissions are not permitted. All respondents must be registered in SAM.gov to be eligible for future contract awards. The required services involve on-site and remote monitoring of VA-funded clinical trials to ensure compliance with ICH E6 GCP standards, VA directives, 45 CFR 46, and 38 CFR 16. Contractors must demonstrate a minimum of 10 years in GCP clinical trial monitoring, with at least five years focused on federally funded research, preferably VA trials. All personnel must hold a bachelor’s degree in a health or science field or be certified as a Clinical Research Associate (CCRA), complete recognized GCP training, and demonstrate proficiency with VA electronic health record systems and Microsoft Office and Adobe Acrobat. Additional requirements include extensive experience in source data verification, clinical record review, and timely reporting of serious non-conformances. Deliverables include site visit reports within seven business days, training documentation within 30 days, and strict adherence to submission protocols using the VA-specific VIS system for invoicing. Performance is evaluated using ad
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Submission Closed
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