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

Statement of Work (SOW) / Performance Work Statement (PWS)

This Performance Work Statement (PWS) outlines the requirements for Good Clinical Practice (GCP) Clinical Research Quality Associate (CRQA) monitoring services for clinical trials conducted by or requested by the Department of Veterans Affairs (VA), Cooperative Studies Program (CSP), Site Monitoring, Auditing and Resource Team (SMART).

The contractor shall provide CRQA monitoring services, including:

• CRQA Visits: Conducting on-site (including virtual equivalents) and off-site (remote) monitoring visits for clinical trials. This includes site initiation visits and routine monitoring visits.

• Pre and Post-Visit Work: Scheduling visits, preparing visit materials, conducting evaluations of study procedures (protocol adherence, informed consent, adverse event reporting, source document review, regulatory documentation, etc.), and preparing post-visit reports and summary letters.

• Program Quality Support (PQS): Developing study-specific site visit tools, creating GCP tools for sites, designing data for casebooks, developing source documentation guidance, conducting off-site record reviews, providing study orientation, and completing required training.

• Sponsor's Designated Representative (SDR) Role: Finalizing and approving reports, reviewing site visit responses, and coordinating corrective actions.

• Timeliness: Visits and reports are to be completed within specified timeframes (e.g., reports within 10 calendar days of the last day on site).

• Quality: Reports must be clear, detailed, accurate, and grammatically correct. Revisions to reports should be minimal (no more than once per submission).

• Communication: Prompt response to calls and queries (within 24 hours or as requested).

• Compliance Reporting: Immediate feedback to leadership on significant or serious non-compliance discoveries.

• Period of Performance: Three (3) years.

• Place of Performance: Various VA facilities and associated non-VA facilities throughout the United States and territories, contractor's place of business, and the SMART office in Albuquerque, New Mexico.

• Contractor Qualifications: Requires a Bachelor's degree in a scientific/health-related field or equivalent licensure/certification, documented GCP training, specific clinical research monitoring training, a minimum of 10 years of GCP clinical trial monitoring experience (with specific consideration for federally funded research), and experience in medical record review and computer proficiency.

• Security: Background investigation (NACI) is required. Contractors must comply with VA privacy and data security policies, including handling of Protected Health Information (PHI)/Personally Identifiable Information (PII).

• Government-Furnished Equipment: A government-furnished laptop and PIV card will be provided.

• Travel: Contractor is responsible for coordinating travel arrangements for on-site visits, with reimbursement in accordance with Federal Travel Regulations. Portal-to-portal travel time is included.

Sources Sought Notice

This is a Sources Sought Notice issued by the Department of Veterans Affairs, RPO-E Research and Development. It is for information and planning purposes only; no quotes are being requested or accepted at this time. The VA is seeking information on potential sources capable of providing Good Clinical Practice (GCP) Clinical Research Quality Associate (CRQA) Monitoring Services.

Potential sources should demonstrate their ability to provide services as outlined in the draft Performance Work Statement (PWS) which is attached. The NAICS code considered is 541990 (All other professional, Scientific and Technical Services) with a Small Business Size Standard of $19 million. The PSC is AN24 (Health R&d Services; Health Research and Training; R&d Administrative Expenses).

Interested parties must submit the following information via email by June 30, 2026, 10:00 AM ET:

• Company name, SAM/DUNS number, address
• Point of Contact information (title, phone, email)
• Company capability to meet the requirement, demonstrating ability to meet PWS requirements
• Company type (small/large) and socioeconomic status (SDVOSB, VOSB, Hubzone, 8(a), WOSB, etc.)
• If services are available on an existing contract vehicle (e.g., GSA), provide contract/schedule number.

Responses should provide sufficient information to determine compliance with subcontracting limitations (VAAR 852.219-75). If a set-aside to SDVOSB/VOSB is planned, vendors will need to complete and return VAAR 852.219-75 with a quote (not required for this sources sought response).

Responses to this notice will be used for planning. A future solicitation announcement may be published. Responders to this notice must also respond to the forthcoming solicitation.

Responses must be emailed to Contracting Officer Renee Kale at renee.kale@va.gov. Facsimile or telephonic responses will not be accepted. There will be no question-and-answer period for this sources sought.