Quality Assurance & Post-Approval Monitoring (QA/PAM) Workflow Design

The contract calls for the design and implementation of Quality Assurance and Post-Approval Monitoring workflows within the Human Research Protection Program system to ensure full compliance with 45 CFR 46 regulations. The work focuses on establishing robust audit trails, verifying training compliance among personnel, and enabling effective post-approval oversight of research activities. The solution must be integrated seamlessly into existing HRPP infrastructure to support continuous monitoring, documentation, and regulatory accountability throughout the research lifecycle. The contract is structured as a subcontract under the University of Georgia’s Georgia office, with a North American Industry Classification System code of 541611 indicating management, scientific, and technical consulting services. The solicitation was posted on July 22, 2026, and responses are due by August 7, 2026. All work is expected to be performed in alignment with federal human subjects protection standards, and the successful bidder must deliver a scalable, defensible, and compliant workflow system that enhances institutional capacity for regulatory adherence without disrupting operational workflows. The place of performance and point of contact details are not specified, but the technical requirements demand expertise in clinical research compliance and system integration.