Quality Management
OWL provides quality management services that ensure clinical trial compliance, data integrity, and inspection readiness. Our seasoned quality professionals support audits, CAPAs, SOP development, and vendor oversight, helping sponsors meet regulatory expectations while maintaining efficiency across the clinical development lifecycle. Expect precision and accountability, at every step.
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Inspection Readiness and Support
OWL helps sponsors prepare for regulatory inspections with confidence. We conduct internal audits, identify gaps, and implement proactive solutions. Our team supports sponsor, site, and vendor inspections — ensuring documentation, processes, and personnel are aligned with GCP, ICH, and global regulatory requirements.
CAPA Management
OWL guides sponsors through Corrective and Preventive Action (CAPA) planning and execution. We investigate root causes, develop targeted solutions, and monitor resolution effectiveness. Our structured, transparent approach supports ongoing compliance and builds trust with regulators and partners across the clinical trial ecosystem.
SOP Development & Optimization
We help sponsors create and refine Quality Management Systems (QMS) that are compliant, practical, and scalable. Our quality experts can audit your QMS and write or revise SOPs for clarity, efficiency and compliance, ensuring your team can consistently meet evolving global regulations and standards including ICH E6(R3), without unnecessary complexity or administrative burdens.
Vendor Oversight
OWL supports robust vendor oversight strategies, from qualification through ongoing performance monitoring and issue resolution. Our experts evaluate risk, assess documentation, and establish feedback loops and audit schedules that hold vendors accountable, while maintaining collaborative relationships. We ensure third-party partners meet your expectations, and those of regulators.