CARDIAC SAFETY / QTc STUDIES

We have an ICU-like unit for the conduct of Thorough QT/QTc studies under the guidance of the E14 document promulgated by ICH and the FDA Guidance for Industry. Containing up to 48 beds in a single large room the unit is specifically designed to allow control of all environmental factors that might adversely influence a thorough QT/QTc study. All forty eight subjects are exposed to the same temperature, humidity, noise levels and other conditions. Thus, controlling to a much greater extent than usual the factors that may cause variation in the data collected in these difficult to control cardiovascular studies. Even though most data in the unit is collected with either 12 lead holter recordings (such as Mortara H-12+) or other 12 lead collection machines, it was opted to flexibly include bedside monitoring including pulse oximetry, ECG, vital signs and ready access to emergency equipment if it is needed. In this way the unit actually is a fully equipped cardiovascular research unit that can be focused on repolarization studies.