Commitment to Quality
and Compliance
Quality Policy
Customer satisfaction and protection
Providing products and services that meet
or exceed customer expectations while protecting donor and customer data privacy
Patient empowerment and protection
It is our duty to encourage our participant
community to positively impact therapy
development, while not only meeting but exceeding industry standards in donor and donor data protection.
Staff empowerment
Stimulating employee awareness, interest,
participation, and aptitude towards
improved business and quality practices.
Continuous improvement
Nurturing, promoting and encouraging
an environment of continuous quality
improvement and compliance.
Sanguine's Quality Policy is designed to ensure our customers continued satisfaction at every Sanguine location. Attainment of our some of Sanguine's core values being Quality, Integrity, and Ethics is the collective responsibility of Sanguine Executive Leadership, Management, and all Sanguine employees.
Our Quality Management System
The Sanguine Quality Management System (QMS) is an integral component of our business. In maintaining our high quality and regulatory standards, the purpose of the QMS is to:
Identify and satisfy the needs and expectations of Sanguine’s customers, employees, and vendors
Maintain compliance with national and international standards, such as
ISO 9001:2015
Achieve and improve overall organizational performance and capabilities
Sanguine management is responsible for the continuous improvement of the QMS by implementing any necessary changes identified through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and quarterly review. All Sanguine employees share responsibility for the effective implementation and
operation of the QMS and annually review the Quality Policy as part of our commitment to compliance.
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. We also regularly self-audit our quality processes.
Quality Management Certifications
All Sanguine locations maintain the appropriate certifications and registrations that demonstrate our commitment to excellence and continuous quality improvement.
Data Privacy and Security Compliance
Access to and the controls around the storage of health data are tightly regulated for good reason. No patient wants their private health data on display and no company or institute engaged in research & development can afford their precious data to become vulnerable. We are committed to data privacy for our patients and customers, as evident by our compliance with national and international standards:
- ISO 27001: Information Security Management System
- ISO 27701: Privacy Information Management
- Health Insurance Portability and Accountability Act (HIPAA)
- General Data Protection Regulation (GDPR) Compliant
Registrations and Licenses
Please download the record of registrations and licenses. Sanguine maintains and updates regularly, as well as our company W9 for additional information.
Human Study Best Practices
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, specific study documentation, and study participant facing information. Both Advarra (statement here) and WCG IRB (link here) are organized and operate in compliance with: the Food and Drug Administration (FDA), Oce for Human Research Protections (OHRP), and the International Conference on Harmonization (ICH).
Sanguine operates under an electronic informed consent process which executes 21 CFR part 11 compliant e-signatures, and Sanguine systems interacting with study participant information are HIPAA-compliant.
Laboratory, Biorepository, and Apheresis Services
The collection, handling, shipping, processing, analysis, and storage of biospecimens are all tightly controlled and recorded in accordance with documented procedures. Such procedures and processes are established using Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Documentation Practice (GDP) principles (GXP). We routinely conduct internal audits and are also regularly audited by our clients, to maintain high levels of quality in our products and workflows.
Specimen Laboratory & Biorepository (San Diego, CA)
Sanguine maintains a 3000-sq ft, fully equipped specimen processing and storage facility located in the San Diego Science Center. The lab is a member of the International Society for Biological and Environmental Repositories (ISBER) and participates in the Biorepository Proficiency Testing Program. All specimens that are being stored by Sanguine or require processing (except serum/plasma separations performed at the donor's home) are delivered to the San Diego lab before being delivered to the sponsor.
See our biorepository page for more information.
Sanguine has demonstrated its ability to process biospecimens to meet or exceed industry standards. See the certificate here.
Apheresis Center (Los Angeles, CA)
Sanguine operates a 2000-sq ft apheresis donation center in central Los Angeles for both the initial screening and collection of leukocyte-enriched blood products (leukopaks) via leukapheresis. The center’s staff also performs some of the leukopak collection day characterization for the certificate of analysis.
See our leukopaks page for more information on apheresis products and services.
Study Kit Office (Woburn, MA)
Sanguine leases a 4300-sq ft kitting suite in Woburn, MA, which contains raw materials used to construct kits for at-home phlebotomy visits. Kits, PPE, and visit instructions are packaged and sent to our mobile phlebotomy sta for in-home visits with our donor population.
Staff Training and Competency
Management assures that all personnel have the necessary training and experience to perform their assigned jobs. Records of training and competency are maintained and documented according to specifications in the QMS.
The Sanguine lab in San Diego is a member of ISBER, the worldwide authority in biorepositories. As a participant in the ISBER-endorsed Biorepository Proficiency Testing Program, the quality performance of laboratory personnel was assessed and validated by a third-party facility.
Sanguine has demonstrated its ability to process biospecimens to meet or exceed industry standards. See the certificate here.
