SAM #36C24E26Q0050

VA Seeks GCP Clinical Research Quality Associate Monitoring Services for Multi-Year Contract

The Department of Veterans Affairs is seeking vendors to provide Good Clinical Practice (GCP) Clinical Research Quality Associate (CRQA) Monitoring Services for its Regional Procurement Office East and the Cooperative Studies Program (CSP) Site Monitoring, Auditing and Resource Team (SMART) at the New Mexico VA Health Care System. - Government Buyer: - Department of Veterans Affairs - Veterans Health Administration, Regional Procurement Office East - Cooperative Studies Program (CSP) SMART, New Mexico VA Health Care System - Services Requested: - Good Clinical Practice (GCP) Clinical Research Quality Associate Monitoring Services - Site initiation visits, routine monitoring visits (1-4 days), pre- and post-visit work, compliance assessments - GCP Program Quality Support (PQS): hourly services for study tool development, off-site records review, training, and Sponsor's Designated Representative (SDR) duties - Reimbursable travel for on-site visits, following Federal Travel Regulations - Quantities and Line Items: - CRQA Visits: 475 per ordering period (total 3 periods) - GCP PQS Support: 2,100 hours per ordering period (total 3 periods) - Reimbursable travel: as needed, per period - Unique Requirements: - Personnel must have extensive GCP clinical trial monitoring experience - Mandatory annual training and security clearances - Deliverables (site visit reports, summaries) due within 10 days of visits - Travel reimbursement requires documentation and follows government per diem rates - No specific OEMs or commercial vendors are named; the opportunity is open to qualified service providers in clinical research monitoring - NAICS code: 541990 (All Other Professional, Scientific, and Technical Services) - Product Service Code: AN24 (Health R&D Services; Health Research and Training; R&D Administrative Expenses)

Description

This is a SOURCES SOUGHT NOTICE only. Responses to this notice will be used for information and planning purposes. No quotes are being requested or accepted at this time with this notice. The Department of Veterans Affairs, RPO-E Research and Development has a requirement for Good Clinical Practice (GCP) Clinical Research Quality Associate (CRQA) Monitoring Services. Potential Sources shall respond with their ability to provide these services as outlined in the draft Performance Work Statement (attached). The North American Industry Classification System (NAICS) code being considered for this procurement is 541990 All other professional, Scientific and Technical Services, and the Product Service Code (PSC) is AN24 Health R&d Services; Health Research and Training; R&d Administrative Expenses. The Small Business Size Standard is $19 million. Responses to this notice shall include the following: 1. Company name 2. SAM or Data Universal Numbering System (DUNS) number (SAM is preferred) 3. Company s address, 4. Point of Contact information (i.e. title, phone number and email address) 5. Company s capability to meet this requirement and any pertinent information which demonstrates the company s ability to meet the above requirements.
6. Company s type of business (small or large) and socioeconomic status whether Service Disabled Veteran Owned, Veteran Owned, Hubzone, 8(a), Women Owned, Small Disadvantaged, etc. If applicable, Service-Disabled Veteran Owned Small Businesses (SDVOSB) and Veteran Owned Small Businesses (VOSB) must be verified with the SBA. Response should provide enough information to determine if the vendor can comply with the limitations on subcontracting as defined in VAAR 852.219-75 and all applicable CFR references where applicable. If set-aside to SDVOSB/VOSB, vendors shall be required to fill out 852.219-75 and return with quote(not required for their response to this sources sought). 7. If services are available on existing contract vehicle (GSA) please provide contract/schedule number. All responses shall be submitted in writing via email no later than 10:00am (ET) June 30, 2026 to Ms. Renee Kale at renee.kale@va.gov. E-mail: renee.kale@va.gov. Facsimile or telephonic responses will not be accepted. There will be no question-and-answer period for this sources sought. Simply responding as an interested party does not constitute your company as a source. Offeror must provide the above requested information. After review of the responses to this sources sought notice, a solicitation announcement may be published on the SAM or GSA website in the near future. Responses to this sources sought announcement are not considered adequate responses to the solicitation announcement. All interested offerors will have to respond to the forthcoming solicitation announcement, in addition to responding to this sources sought notice. All interested parties must be registered with System for Award Management (SAM) at https://www.sam.gov in order to be eligible for award of Government contracts.

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