Case Study: Large Healthcare System achieves regulatory compliance and preserves Medicare/Medicaid funding with Advarra

Large Research Healthcare System Maintains Compliance through Internal Program Assessment

Large Healthcare System needed to preserve a reputation for high ethical and regulatory standards and protect Medicare/Medicaid funding by assessing institutional risk across good clinical practice (GCP), IRB/HRPP, and clinical trials billing compliance. To meet this need, the organization engaged Advarra’s Institutional Research Center of Excellence to perform a comprehensive clinical research operations assessment.

Advarra conducted concurrent, milestone-driven assessments (assessment agenda, draft report, final report) and provided strategic regulatory guidance and tailored recommendations. As a result, Large Healthcare System identified and closed compliance gaps, remained compliant with local, state, and federal regulations, maintained its research reputation, and mitigated the risk of costly outcomes such as multimillion-dollar fines or loss of federal funding.