Preclinical Liaison
We offer preclinical liaison consulting services for your favorite Test Article (TA), and Investigational Product to be, that needs to go through preclinical testing, whether GLP or non-GLP.
Samples from toxicological studies will be bioanalyzed to determine different toxicological aspects of the TA.
Methods will need to be developed and validated to GLP in pharmacokinetic assays to determine the concentration of the TA in various biological matrices such as blood or tissues.
Other methods that are very popular due to the omnipresence of biopharmaceuticals in the drug development pipelines are immunogenicity assays. They are very common, but also require an advanced level of scientific insight in order to better manage the workflow to completion and the reporting.
Other important bioanalytical methods comprise biomarker assays. They are important to assess tissue-specific toxicity, but also the effectiveness of TAs as surrogate endpoints that predict a treatment effect on a final clinical outcome.
ZenTrial specializes in Ligand-Binding Assays in support of pharmacokinetic, biomarker, and immunogenicity assays. ZenTrial also has a knack for Elispot assays that test the immune cell-response typically in PBMC cells. We have extensive expertise with nucleic-acid based Test Articles and Investigational Products such as mRNAs and oligonucleotide-based therapeutics.
- Immunogenicity
- Bioanalytical Method Development and Validation
- Biomarker Assays and Workflow
- Ligand Binding Assays (ELISA)
- Support with Toxicology Studies & Study Plans