Expert GCP auditing services for clinical trial compliance and data integrity.
Clinical Trial Process Audits
Ensure protocol adherence, ICF/IRB compliance, and participant privacy (GDPR/HIPAA) throughout your trial.
Data Integrity Audits
Validate EDC systems, verify source data (SDV & ALCOA+), and ensure TMF completeness for robust data quality.
Global Reach
Serving clients in Europe, USA, and Japan effectively.
Risk Management & CAPA Support
Track critical findings, support CAPA implementation, and mitigate risks for successful trial outcomes.