Third-Party GCP Audit Program
Study-level and site-level audit execution, including TMF quality checks and vendor oversight.
- Annual risk-based audit planning
- Site process walkthrough and interview drills
- TMF traceability and completeness review
Service Modules
End-to-End Clinical Quality Service Portfolio
Modular, inspection-oriented service design for sponsors, biotech teams, and global study programs.
Regulatory Mock Inspection
Pressure-test your teams against NMPA/FDA/EMA inspection logic and evidence expectations.
- Document room simulation
- Critical question rehearsal
- Rapid CAPA prioritization
RBQM & Continuous Oversight
Build quality signal dashboards and governance rhythms for ongoing risk control.
- KRI/QTL framework definition
- Cross-vendor signal consolidation
- Escalation and decision routing
Data Integrity and Digital Compliance
Strengthen source data controls, audit trail review, and CSV governance across digital systems.
- ALCOA+ gap diagnostics
- Part 11 / Annex 11 readiness
- System lifecycle control checks
Standard Deliverables
Executive risk dashboard
Evidence-linked observation register
Prioritized CAPA roadmap
Follow-up verification checklist
Need a custom scope?
We can combine modules into a project plan aligned to your timeline and study complexity.
Request Scope Design