Quality and compliance
Certifications, Licenses, and Awards
We are committed to data privacy for our patients and customers, as evident by our compliance with national and international standards.
ISO certifications
Sanguine Biosciences has achieved three notable ISO certifications, ISO 9001, ISO 27001, and ISO 27701, further demonstrating its commitment to quality, information security, and privacy management.
View our IAF profile.
Data privacy and regulatory compliance
HIPAA
Health Insurance Portability and Accountability Act (HIPAA). Sanguine systems interacting with study participant information are HIPAA-compliant.
GDPR
General Data Protection Regulation (GDPR) Compliant.
21 CFR Part 11
Sanguine operates under an electronic informed consent process which executes 21 CFR part 11 compliant e-signatures.
IRB review
All Sanguine study protocols, which include all Sanguine at-home and apheresis collection programs, are conducted under an Institutional Review Board (IRB). Sanguine utilizes two internationally-recognized IRBs (Advarra and WCG IRB) for review and approval of all study protocols.
Independent assessment and proficiency testing
VERIF.i® by Scientist.com
To facilitate client pre-assessment, Sanguine validated its quality processes and compliance through VERIF.i®, the standardized and objective auditing service conducted by Scientist.com.
ISBER membership
The lab is a member of the International Society for Biological and Environmental Repositories (ISBER) and participates in the Biorepository Proficiency Testing Program.
Proficiency certificates
Sanguine has demonstrated its ability to process biospecimens to meet or exceed industry standards.
Such procedures and processes are established using Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Documentation Practice (GDP) principles (GXP).
Registrations and licenses
Please download the record of registrations and licenses Sanguine maintains and updates regularly.
Questions about quality or compliance?
Contact our team and we will get back to you within one business day.