Bioresearch Monitoring (BIMO) Program / Investigative Authority
The Investigative Mind.
Former FDA BIMO Investigator helping sponsors, CROs, and clinical sites achieve inspection readiness, strengthen compliance systems, and navigate regulatory risk with confidence.
Sereen Morgan Murray represents the rare intersection of federal regulatory authority and strategic industry foresight. As a former investigator with the U.S. FDA's Bioresearch Monitoring (BIMO) Program, she has conducted both domestic and international inspections across clinical research environments, evaluating compliance with critical regulatory frameworks including 21 CFR Parts 11, 50, 54, 56, and 312, as well as Good Clinical Practice standards.
Her work has directly influenced the integrity, safety, and regulatory outcomes of clinical trials supporting life saving therapies. Today, she brings that same investigative precision to industry, helping organizations identify compliance gaps, strengthen oversight, and prepare for regulatory scrutiny with confidence.
Subject Identification
Morgan-Murray, S.
Former FDA Authority
Extensive experience in FDA Bioresearch Monitoring (BIMO) Program inspections across United States and international clinical sites, with direct application of regulatory frameworks including 21 CFR Parts 11, 50, 54, 56, and 312, and Good Clinical Practice.
Strategic Compliance and Risk Identification
Proven ability to identify compliance gaps before they escalate into regulatory findings, enabling sponsors and CROs to prevent delays, protect data integrity, and maintain inspection readiness.
Advisory Leadership
Trusted advisor to sponsors, CROs, and clinical sites, translating regulatory expectations into actionable strategies that strengthen oversight, improve execution, and ensure sustained compliance.
SMM Arete GxP Consulting Services
Under her leadership, SMM Arete GxP Consulting Services serves as a premier boutique advisory, trusted by global sponsors, CROs, and clinical sites across the United States and internationally. The mission is to embed operational excellence, regulatory precision, and ethical rigor into every stage of clinical development.
- check_circleMock FDA BIMO Inspections aligned with CP 7348.810 and CP 7348.811
- check_circleSponsor and CRO Oversight Assessments
- check_circleInspection Readiness Strategy and Execution
- check_circleCAPA Development and Remediation Planning
- check_circleStudy Documentation Review
- check_circleSOP Review and Compliance Gap Analysis
- check_circleInspection Readiness Training for sponsor, CRO, and site level teams
Outcome Driven Positioning
Sereen’s approach is grounded in real world regulatory enforcement experience, enabling organizations to:
• Identify and remediate compliance gaps proactively
• Strengthen sponsor and CRO oversight frameworks
• Prevent costly regulatory delays and findings
• Build confidence in inspection readiness across all levels
Credibility Line
Trusted by global sponsors, CROs, and clinical research sites across the United States and international markets.