BioIVT is committed to providing high quality human and animal biological products and related-services with world-class customer service.
We distribute human and animal biologicals of only the highest quality and we stand behind the specimens by providing an unconditional product guarantee. As a partner to our clients, we provide exceptional customer service before, during and after shipment. Our products are delivered promptly, ready for use. In addition, our PHASEZERO Services are designed to meet customer requirements’ every time.
All BioIVT facilities have the following Quality Management Systems in place:
- Approved Supplier Program
- Customer Complaints, Non-Conformances, CAPA
- Internal Audits & Spot Checks
- Document Control
- Formal Training system and documentation
- Change Controls
- Environmental Control
- Equipment Control
- Safety program & records
- Product Recall and Returns
- Quality checks
Our facilities hold a variety of globally recognized accreditations, including:
BioIVT maintains a global network of sites who conduct subject recruitment, informed consent and scientific activities. All of our activities, and those of our collaborators, are conducted in accordance with applicable laws, regulations, and ordinances. BioIVT confirms that the following activities have been completed by ourselves our collaborators, as necessary:
- Institutional and Independent Review Board approval (IRB)
- Privacy officer authorization
- Government licenses
- Industry accreditations
- General Data Protection Regulation (GDPR)
We continually monitor our practices to conform to evolving external scientific, legal and ethical requirements.
The Department of Health and Human Services regulations for the protection of human subjects (45 CFR §46.116 and §46.117) and Good Clinical Practice (GLP), (ICH E6) require that informed consent will be sought from each prospective subject or the subject’s legally authorized representative and will be appropriately documented in writing. Furthermore, we have various forms of informed consent that are utilized for the collection of various biospecimens in different disease areas. These forms, along with their corresponding protocols, are reviewed and approved by appropriate regulatory and ethics authorities. Special situations may exist where the informed consent of the subject (or the subject’s legal representative) to participate in research is unavailable. For example, BioIVT has worked with hospitals to recover pathology specimens and data no longer needed for diagnostic purposes. In such circumstances, BioIVT obtains a waiver of informed consent from an institutional review board to enable the research.
BioIVT values the security of confidential medical information. We require identifying information about the subject to be removed at the source of collection; this information is not transferred to our clients. Additionally, BioIVT promotes the responsible use of genetic information obtained through research. We continually revise our consent processes to ensure that subjects are aware of the risks of research involving genetic information.
Although we are not a covered entity, BioIVT also assists its collaborators in obtaining Patient Authorizations that comply with the U.S. Health Insurance Portability & Accountability Act (HIPAA). The levels of security applied to patient health information allow our customers to have confidence in BioIVT clinical data.
BioIVT is licensed by the United Kingdom Human Tissue Authority to store human organs, tissues, and cells for research purposes other than for a specific ethically-approved research project. We maintain a designated professional to oversee full compliance with all United Kingdom Human Tissue Authority Codes of Practice and directives.
BioIVT works closely with our clients to ensure that our practices are consistent with their internal policies and standards. Please submit inquiries about bioethics issues through our Contact Us form.
- Physical inspection of each sample
- All cold storage, including liquid nitrogen, is monitored and on back-up systems.
- All pathology diagnosis or staging are confirmed by board certified pathologists, using H/E slides and (when required) IHC slides. Additionally, each specimen is evaluated and scored for condition, cancer percentage, necrosis and other physical factors.
- Case reports, accompanying test results and paperwork are reviewed and entered into a database for sample management and client searching