Your Trusted Imaging CRO Partner:
Delivering Regulatory Excellence Worldwide
- 40 PMDA approvals and an FDA approval
- Fully audited Quality Management System
- Two customer audits per month over 18 years
- Zero critical findings from sponsor audits
- GCP, HIPAA and 21CFR Part 11 compliant
- Validated computer systems, audited and customizable
- FDA Guidance for Imaging Endpoints based SOPs
- Created GDPR personal information handling policy
- Currently preparing for ISO27001 certification