Human Tissue and Biofluids Procurement

FIDELIS RESEARCH recognizes the increasing importance of biospecimens, which are becoming essential tools for the translation of our client’s research into new products.


European Compliance

FIDELIS RESEARCH maintains the principles of autonomy, privacy, safety and informed consent.

We promote voluntary donation of surplus human tissues and clinical information for medical research. The tissue we collect is Surplus surgical tissue that would otherwise be discarded following surgery performed for medical treatment.

We ensure that all of our activities, as well as those of our collection sites, are conducted in accordance with applicable laws, regulations, and ordinances. All informed consent form templates are subject to review and approval by designated ETHICS COMMITTEES at the collection sites.

FIDELIS RESEARCH 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.

FDA compliance

The US Food and Drug Administration has provided numerous guidances to the biopharmaceutical industry on the use of human tissues as well as the import of tissues into the United States. Below is a sample of relevant statements:

  • Draft Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human
  • Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
  • Guidance for Industry: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity
  • Compliance Guide
  • FDA Oversight of the tissue Bank industry
  • FDA Guidance on import/export of human tissues to US
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