Our Bioanalysis department (Clinical and Preclinical Bioanalysis) has strong relationships with clinical Phase I units and can support clinical drug development programs through tailored bioanalytical methods. Our experienced bioanalysis teams provide dedicated expertise and practical support to develop robust, reliable and efficient methods.

Our capabilities to support Clinical Bioanalysis include:

• High capacity qualitative and quantitative LC-MS/MS analysis on triple quadrupole and linear ion trap mass spectrometers.
• Robotic automation for high throughput sample analysis.
• Dried Blood Spot technology.
• 24/7 sample receipt management and extensive storage capabilities at -20ºC and -80ºC.
• Scientifically trained report writers who work directly with our scientists to ensure quality reports to meet your deadlines.

Clinical Bioanalysis services include:

• Method Development - A dedicated method development team provides expertise and practical support to develop methods that are robust and reliable in the most time efficient way possible.
• Validation - Validations performed in accordance with OECD and FDA guidelines.
• Sample Management - 24/7 sample receipt and secure management. Fast sample turnaround utilising robotics for high throughput analysis, typically within 48 hours from point of receipt for first-in-man studies.
• Clinical Support Services - Support for Phase I, II, III and IV clinical PK, bioequivalence, bioavailability and drug-drug interaction studies.
• Pharmacokinetics/Pharmacodynamics - Analysis and reporting of data from Phase I/II trials. This team has experts in the fields of pharmacokinetics, biostatistics and SAS programing who are experienced in providing fast turnaround analyses. We can advise on study design, sample size estimation, produce statistical analysis plans, tables, listings and figures (within SAS) and perform analyses.