Developments, news and strategies for drug development specific to phase I through Phase III global clinical trial management, execution, project management and outsourcing. Go→
News, articles and issues specific to clinical trial practice and implementation at the investigative site level. Go→
Strategies and innovations related to how clinical professionals are utilizing technology internal and external to their organizations to advance clinical trials. Go→
News, articles and issues specific to laboratories role in the clinical trial, including ECG, imaging, genotyping, tissue samples and more. Go→
News, developments and strategies for clinical trials conduct in relation to the FDA, EMEA and other global regulatory authorities overseeing the drug development industry. Go→
News, articles and strategies related to clinical trial design which impact postmarketing studies, therapeutic areas, adaptive trials, statistics, protocols and more. Go→
Certara, which offers software and scientific consulting services for drug development, announced the launch of itsPhoenix QT+ cardiac safety assessment tool. This product provides data processing, statistical, and modeling capabilities in regard to Thorough QT (TQT) study requirements under the ICH E14 Guidelines (ICH, 2005). The product provides a comprehensive analysis of electrocardiogram (ECG) interval data collected in TQT studies and sub-studies in other clinical trials to determine whether a drug is at risk for cardiac depolarization prolongation.
Read the full release here.