Use of Human Biological Samples at Covance
Research type
Research Study
Full title
Donation of Human Tissues for drug development at Covance Laboratories Limited
IRAS ID
282700
Contact name
Anthony Chadwick
Contact email
Sponsor organisation
Covance Laboratories Limited
Clinicaltrials.gov Identifier
S-HAR-GEN-300, Covance SOP
Duration of Study in the UK
10 years, 0 months, 2 days
Research summary
In order for new drugs and chemicals to be licensed they must undergo a series of tests within the safety development framework, the testing of these drugs and chemicals is a regulatory requirement.
Donated human samples are used for the performance of a variety of study types across several departments within Covance. For example; as a reference standard (control sample) for samples from subjects in clinical studies, to assess the impact a test chemical may have on human cells, or as a control matrix for in vitro assay development or validation. Human tissue samples may be used in studies performed by operational departments at Covance, including (not exclusively) Bioanalytical Services, BioPharm CMC, Clinical Pathology Services, Genetic Toxicology, Immunology & Immunotoxicology and Metabolism. Parts of the analysis or peer review of samples may be conducted at either one of our client facilities or a nominated third party.
All laboratory procedures and any treatments with test chemicals are performed on the tissue samples after donation from the donor, therefore no donors are exposed to any test chemicals at any time.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
21/YH/0129
Date of REC Opinion
20 Aug 2021
REC opinion
Favourable Opinion