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
- 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
