Clinical Quality Assurance & Inspection Readiness
Comprehensive evaluations for systems, vendors, sites, documentation, and CAPA activities.
Clinical Quality Support
Our clinical quality support helps sponsors evaluate systems, vendors, sites, documentation, CAPA activities, and inspection readiness against the agreed standards and scope. Globyz Clinical Solutions coordinates this service in collaboration with CEBIS USA LLC, its U.S. affiliate and clinical research arm. The teams work together within an agreed delivery model, and clinical studies are conducted through CEBIS USA.
Discuss a Quality Requirement
Quality Assurance
Guaranteed compliance
Quality Assurance Capabilities
Quality Planning and Oversight
- Quality planning and risk assessment support
- SOP and controlled document review
- Vendor qualification and oversight support
- Study quality review and issue trend evaluation
- CAPA and effectiveness check support
Audit Services
Audits may include investigator sites, vendors, systems, processes, documents, or study activities according to an approved audit plan. Scope, standards, independence, reporting, and follow up are agreed before the audit.
Inspection Readiness
- Readiness planning and responsibility mapping
- Document and evidence review
- Interview preparation and mock inspection support
- Issue triage, remediation planning, and response support
- Inspection room and request tracking support where agreed
No Guarantee of Outcome
Quality support improves preparation and visibility but does not guarantee an inspection result. Findings and risks are communicated objectively, with recommendations prioritized by impact and feasibility.
Partner With Globyz
Share the protocol or synopsis, product details, expected safety reporting timeline, and regulatory responsibilities to get started.