Summary

Assessing the cardiovascular safety of novel compounds is an important clinical drug development objective for drugs with preclinical cardiovascular safety signals and agents for which a cardiovascular class effect is suspected. Consequently, for most compounds, regulatory authorities still expect to see a Thorough QT (TQT) study according to ICH-E14. PRA Health Sciences (PRA) provides the expertise you need to optimize study design and execution for TQT studies and ECG assessments during early clinical development and in clinical pharmacology studies.

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ECG Assessment During TQT and Early Clinical Studies