Robust clinical bioanalysis
Alderley Analytical offers a Good Clinical Practice (GCP) compliant clinical bioanalysis service to support your drug molecule as it enters the clinical development phase of the drug discovery process, where robust and validated assays will help you get to market more quickly.
Our clinical bioanalysis service involves the following processes:
- Method development
- Method validation
- Stability testing
- Sample analysis
Expertise in method development
We have developed bioanalytical methods for clinical development projects for many years. We take this experience to ensure that once developed, our assays will pass all the validation criteria expected from the FDA or EMA regulatory authorities. Our robust approach combines with the latest technology to develop bespoke assays including ultra-sensitive limit of quantification levels where required.
Following the FDA and EMA regulatory guidelines for the conduct of bioanalytical validations, our method validation studies are designed to confirm the robustness, accuracy and precision of the assay. They also check the integrity of samples and solutions when subjected to specific conditions in the laboratory:
- Matrix effects
- Linearity and range
- Lower limit of quantitation (LLOQ)
- Upper limit of quantitation (ULOQ)
- Stability evaluations (stock solution, freeze/thaw, short term matrix stability, whole blood stability and post-processed sample stability)
- Effect of haemolysed and lipaemic samples and dilution evaluation
Sample storage stability
We can set up storage stability studies to establish the long term stability of your human biological samples in nominal storage conditions of -20°C or -80°C. The storage stability duration evaluated can be designed to your own specifications; some projects may only require us to evaluate the effect on samples stored up to one month where some may require storage stability evaluation for up to two years.
Clinical sample analysis
The samples will be stored in our secure monitored storage facility (-20°C or -80°C) until analysis.
The quality of the data produced during the sample analysis will be monitored by pre-defined acceptance criteria. Incurred Sample reanalysis (ISR) will also be performed, where we repeat certain samples more than once to demonstrate the reproducibility of results from samples derived from the human volunteers or patients.
If a fast turnaround is needed to support projects such as dose escalation studies, we’ll deliver rapid results to support your decision making.
Human sample analysis is conducted according GCP regulations.
Data analysis and reporting
All the data we produce goes through rigorous Quality Control (QC) checks and is inspected in-house by our Quality Assurance (QA) team.
Your formal study report can be presented in a template you provide, or you can choose one of our in-house templates.