ACM Global Central Lab, the central laboratory that continually defines the customer-service standard with its flexible approach, has expanded its clinical trials services with the introduction of Drug-Induced Organ Toxicity (DIOT) Monitoring.
The DIOT Monitoring programme provides trending reports for any conventional biomarkers tested, which is tailored to client requirements. It focuses primarily on real-time detection and monitoring of elevated liver toxicity biomarkers, which signal potential drug-induced liver injury (DILI). This program rigorously 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.
“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.”
The novel 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 entered 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, and at client request, ACM Global scientific staff will be available for consultation to assist in an enhanced assessment of the patients impacted.