PD Analysis is the assistance with design, regulatory requirements and final data interpretation. Often it can be the difference between the success and failure of a drug. The ever increasing relevance of PD biomarkers is best demonstrated by the 26% success from phase I to acceptance with biomarker Vs 8% without a biomarker.
We help with the design, sample collection, sample shipping, method development/validation, data interpretation, regulatory requirements, and long term testing of your PD assays. Those assays can be serum/plasma analytes, cell based, or live cell assays. We have the experience and expertise supporting studies from preclinical through phase IV.
KCAS has the team for quick, 24 hour from sample receipt to QCed data for live cell testing, and support of late phase clinical trials. We understand the complex PD analysis such as in vitro stimulations to screen drug candidates and how to support Ex Vivo autologous gene and cell therapies.
Clients often choose us because we can understand regulatory requirements and effectively support PD programs for both preclinical and clinical trials.