Outsourced clinical models require strong, independent oversight to ensure quality and compliance are maintained.
I provide QA oversight across the clinical trial lifecycle, supporting sponsors in managing CROs and vendors while maintaining visibility of quality and compliance risks.
This includes:
• Oversight of CROs and vendors supporting clinical programs
• Review of performance metrics, KPIs, and sponsor-facing reporting
• Identification and escalation of emerging quality and compliance risks
• Support for issue management, deviations, and CAPA activities
• Integration of quality oversight into day-to-day operations
The focus is on providing experienced, practical oversight that strengthens quality without slowing development.
