ACM Global Central Lab has expanded its clinical trials services with the introduction of Drug-Induced Organ Toxicity (DIOT) Monitoring, which provides trending reports for any conventional biomarkers tested, and is tailored to client requirements. It focuses on real-time detection and monitoring of elevated liver toxicity biomarkers, which signal potential drug-induced liver injury (DILI). This program follows the 2009 FDA Guidance for Industry on Drug-Induced Liver Injury. Other organ toxicity monitoring services offered include drug-induced kidney injury and drug-induced bone marrow injury.
The DIOT Monitoring service provides clients with real-time trending reports that are generated when the critical level of each analyte is detected in a patient. Once in the surveillance system, the patient will continue to be monitored by ACM Global scientists until the end of the study. As part of the DIOT service, the company provides scientific consultation to assist in an enhanced assessment of the patients impacted.
“Our clients are very interested in better ways to detect DIOT, and particularly DILI, as it is a major cause for the withdrawal of drugs and drug candidates,” said Kathleen Murray, executive director, Scientific Affairs at ACM Global Central Laboratory. “As part of our DIOT surveillance services, our scientific and data management experts work in close collaboration with our clients to provide the optimal monitoring service for their studies.”