Regulatory Affairs and Bioethics
REGULATORY AFFAIRS AND BIOETHICS
CellMade obtained required authorizations from the French Ministry of High Education and Research, in addition to the Committee of Persons Protection for the Use, Collection, Transformation, Storage and Transfer of human-origin tissues and body fluids under a for research use only label. The Company also obtained authorization for importation and exportation of human-origin tissues and body fluids under a for research use only label. Moreover, CellMade is registered to the CNIL and respects data protection policies for clinical and biological information collected from volunteering donors.
CellMade works towards high ethical standards for the protection of its volunteering donors. No donation is remunerated and no sample is collected before signature of Informed Consent. Each donation is anonymized by the Clinical center before transfer to CellMade and we proceed with a rigorous double de-identification of obtained samples, assuring volunteering donor’s full anonymity.