While BioIVT’s name is new, our core business units have been in operation for over 35 years as providers of high quality biospecimens and related services, including human and animal biofluids and tissues from both normal and diseased donors. Our experience across all types of biospecimens means we can source the right specimen with the right data at the right time. Sourcing certain human biomaterials for research is not always easy, but with the breadth of clinical sites in our network, dedicated personnel for ethical sourcing, quality control, auditing and project management, underpinned by our strong quality management system – we can ensure our clients have confidence in our ability to appropriately source those hard to get, essential research resources.
BioIVT has over 200 IRB approved collection sites located around the world, including US, EU, Asia, Africa and South America. Our sites span a range of clinical operations, from local doctor’s offices to large health systems to donor centers. BioIVT works with local and centralized US-based IRBs, EU-based IECs, and Health Ministries in other countries as required and is in compliance with our UK HTA license for the storage, use and disposal of human biomaterials. Furthermore, our regulatory team stays abreast of current regulation changes and their impact through continuous education, such as attendance at seminars, webinars, white paper review, and on-going team meeting discussions, among other activities.
For additional information about the ethical use of human biological specimens, please download the BioIVT created content below.
[WEBINAR] Gaining Clarity: Unique Considerations for the Ethical and Regulatory Use of Human Biospecimens in the EU/UK
Navigating the requirements for the ethical collection and use of non-US human biospecimens for research can be overwhelming. Hear from Troy Brinkman detail the unique considerations surrounding the bureaucracy and oversight in the use of human biospecimens in the EU and UK.
[VIDEO] Key Points to Human Biospecimen Use for Research
This video highlights key concepts in the maze of regulations and permissions needed when collecting and using human specimens for research.
[ARTICLE] Consent and Biospecimen Collection in Human Research
Traversing the European legal and ethical landscape around the use of human biospecimens (HBS) is complicated, but an essential skill for researchers. Read this article, published in European Biopharmaceutical Review in January 2019, to hear insights from two of our BioIVT about how to ensure the proper authorizations and types of biospecimens are obtained before your study begins.
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[WEBINAR] Gaining Clarity: Ethical and Regulatory Considerations and Common Misconceptions in the Use of Human Biospecimens
Learn the common misconceptions surrounding the bureaucracy and oversight in the use of human biospecimens for research. Developed specifically for regulatory personnel and all levels of researchers, this webinar provides insight and guidance as presented by David Forster, Chief Compliance Officer, WIRB-Copernicus Group and Cathie Miller, Director of Product Marketing, Personalized Medicine from BioIVT.
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[WHITE PAPER] Recommendations to Consider When Sourcing Human Biospecimens
The procurement and use of human biospecimens for life science researchers is complex and challenging. This white paper will help unwrap the layers of bureaucracy and oversight, providing guidance to all levels of researchers around the globe
[GUIDE] Questions to Ask Your Human Biological Specimens Provider
Selecting a provider of human biological specimens (HBS) can be daunting. Obtaining high-quality biospecimens from a provider who is an expert in regulatory and industry requirements is essential for success. Download the guide for the 12 questions and additional insight when evaluating specimen providers
[INFOGRAPHIC] Key Points to Human Biospecimen Use for Research
This infographic was developed by our experienced team of quality experts and provides a roadmap to help you navigate the maze of regulations and permissions needed when collecting human samples. Click here to request a printed version.