Clinical bioanalysis

The processes at Ardena are GCP compliant and therefore we can support regulatory clinical studies through phase I-IV.  We analyse matrices such as blood, plasma, urine, CSF, nasal washes, sputum and many others. We are experts in the isolation of PBMCs.

In method development and validation, our focus is always on robustness, using state-of-the-art instrumentation to develop the most sensitive assays possible. Samples are analysed within agreed timeframes and to GCP regulations. The samples will be stored in our secure temperature monitored storage facility (-20°C or -80°C) until analysis. With our fast turnaround service, we can deliver sample results within required timelines to allow rapid decision making during dose escalation studies. All the data we produce goes through rigorous Quality Control (QC) and source data verification is done in-house by our Quality Assurance (QA) team. The bioanalytical study report can be presented in our in-house templates or in a template you provide.