TetraQ bioanalytical work relies on a dedicated group of highly trained staff, ranging from our experienced senior scientists to the Quality Assurance and sample handling teams. The largest part of our sample analysis work supports Phase 1 clinical trials in Australia (both healthy volunteer studies and cancer trials). However, we can provide support to later-stage trials and international or multi-national clinical trials as requested. We also conduct sample analysis for rodent studies from our in-life facility. TetraQ has supported bioanalytical studies in dogs, sheep and non-human primates and biomarker studies in humans.
Regardless of whether a study involves small molecules or biologics, it is essential to have a suitable method for determining analyte concentration. For non-proprietary drugs, a validated method may in some cases already be available at TetraQ. However for first-in-human studies, a new method will be needed, generally based on a sponsor method for a preclinical matrix such as plasma or serum. TetraQ can develop a method in the corresponding human matrix, which may involve improvements such as greater sensitivity or a change in internal standard. Once method development is complete, a full validation is run to meet regulatory guidances. This will ensure that sample analysis will meet quality criteria. Once this stage is complete, it is possible to proceed to supporting a clinical trial.
Depending on sponsor requirements, TetraQ can in some cases acquire data at a research-only level for ends other than regulatory submission. This situation can arise with non-GLP preclinical studies, or may involve analysis of biomarkers. Equally, if a method has been fully validated in another facility, TetraQ can carry out partial validation prior to clinical sample analysis, or cross-validation for data integration from different facilities. We are happy to discuss sponsors’ needs and recommend a cost-effective path forward.