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Everything we do is about improving patient lives. We are committed to protecting patient data through global compliance including IRB/Ethics, FDA, and international regulatory requirements.

Human subject compliance

  • Health Insurance Portability and Accountability Act of 1996 (HIPAA)
  • 21 CFR 50 Protection of Human Rights
  • 21 CFR 56 Institutional Review Boards
  • IRB/Ethics Compliance
  • Informed Consent

Biorepository & lab compliance

  • Good manufacturing practice (cGMP)
    • Biologics (21 CFR 606)
    • Human cells, tissues, and cellular – tissue-based products (HCG/Ps; 21 CFR 1271 Subpart D)
    • Good laboratory practices (GLP)
    • ISO 9001 Certification
    • ISO 13485 Certification
    • CLIA Certified
    • CAP Accredited
    • 21 CFR 11-compliant Temperature Monitoring System
    • International Society of Biological and Environmental Repositories (ISBER)
    • International Air Transport Association (IATA)

Quality Management System

  • Good Clinical Practice (GCP)
  • GDPR
  • Quality Management Program (QSR, 21 CFR 820)
  • 21 CFR 11-compliant Data Management System
  • Certified Clinical Research Associates (CCRAs)
  • ICH E6 GCP