ACM’s bioanalytical scientists work seamlessly with you, from developing assays to reporting data. Our pharmacodynamic (PD) biomarker studies enhance traditional drug development methods. Using advanced methodologies to study biomarkers in the evaluation of a drug’s performance in patients receiving treatment who are in clinical trials. This complements our drug analysis services since both PK and PD testing can be performed in the same laboratory, requiring one plasma sample per patient. Our expanding reach opens up greater opportunities in the biomarker arena to connect CLIA and GLP settings.
Our methods meet EMA and FDA guidelines and studies are conducted to GLP and GCP standards. We have a broad understanding of global regulatory processes in all areas of drug development from conducting bioanalysis studies that are ready for regulatory submission for a new drug to supporting the reformulation of existing drugs or medical devices. We are your experienced partner in navigating what can be a complicated landscape.
Our state-of-the-art systems deliver accuracy and reliability.
We understand the need for high-quality data and the importance of finding new ways to look at clinical research. For that reason, we use only LC-MS/MS platforms to quantify and investigate the absorption and excretion of drugs and their metabolites during the drug development process. Our smarter testing methods range from simple sample dilution to complicated solid- phase extraction and derivatization methods. We also have experience in a large library of validated bioanalytical methods for a multitude of drugs, for rapid initialization and analysis of study samples.
Our solutions and approach focus on your needs.
Our approach to development is based on your molecule and tailored to meet your specific individual requirements and goals, ensuring full satisfaction. We are proactive and take pride in the honesty and transparency we bring to the table. From initial method evaluation to study development improvements, we stay on track to meet your goals and keep you informed and involved every step of the way.
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