We have extensive experience with:

• Sensitivity & specificity evaluations
• Comparator and method correlation studies
• Multi-swab and multi-matrix testing
• CLIA-waived and point-of-care device assessments
• Self-collection and usability studies
• Enrollment of symptomatic & asymptomatic populations

Our workflows generate regulatory-ready datasets for FDA, CE, and global submissions.

We operate in:

• United States — independent research site (California)
• Eastern Europe — strong partner site network

This allows global access to diverse patient populations and rapid recruitment.

Due to our integrated model and established processes, we provide:

• Rapid feasibility assessments
• Fast IRB submission and approval
• Immediate site activation upon approval
• Accelerated patient recruitment

Sponsors typically experience significantly shorter start-up timelines with us.

Our Quality Management System (QMS) aligns with:

• ICH-GCP
• FDA regulations
• HIPAA & GDPR
• ISO-aligned quality and security standards
• IRB-approved protocols

We maintain:

• Controlled SOPs
• Training and competency documentation
• Internal audits
• CAPA processes
• Complete traceability

We are audit-ready at all times.