KCAS supports all aspects of small and large molecule bioanalysis for preclinical and clinical studies. All of our services are FDA audited and fully compliant.
- Ligand-binding assay (LBA) method development
- Method transfer and optimization
- Pre-study LBA method validation
- Analysis of study samples from PK, TK, PD and vaccine efficacy studies
- Non-GLP Discovery Support
- GLP method development and validation
- Method transfer for sponsor-supplied methods
- High throughput analysis of biological samples for preclinical and clinical studies
- Clinical trial support for global studies and customized sample collection kits
- Large sample storage capacity for reliable sample tracking
- In-depth knowledge and experience in method development and kit adaption
- Fit-for-Purpose method qualification and validation
- Multiple-analyte panel measurements by ECL-based assays using MSD Imager 6000
- Single-analyte measurements by ECL, ELISA, RIA, methods
- Measurements in both human and animal matrices
- Nominal or no-cost qualification for most multiplex panels
KCAS’ validated rapid spectrophotometric Alkaline Hematin (AH) method is acknowledged as the definitive assay for menstrual blood loss (MBL) by recognized experts in the Women’s Health Field.
KCAS offers a wide range of services to ensure sample processing integrity, properly trained clinical sites and regulated long-term sample storage for our pharma, biotech and CRO clients.