The collaboration seeks to maximize the likelihood of success in the assessment of QT as part of Phase I or TQT trials. Alex Zapesochny, President and CEO of iCardiac Technologies, told Outsourcing-Pharma.com this will require that both the Phase I site and the ECG core lab “be very experienced and committed to capturing and using the highest quality data.”
“SNBL and iCardiac are both highly respected as leaders in their respective fields and they share a commitment to optimizing ECG data quality,” Zapesochny said.
Both organizations will also invest time and resources to educate the Japanese market about recent regulatory changes, which affect how cardiac safety are assessed as part of drug development.
Optimizing precision in cardiac safety studies
“A primary challenge in a cardiac safety study is making sure all steps are taken that optimize the ultimate precision level of the study,” explained Zapesochny.
Zapesochny said this begins with making sure the site is well-trained on the equipment and the processes.
“Once the data is received by the ECG core lab, the key challenge becomes finding a consistent way to determine which beats are the most representative of each time point and measuring those beats in an accurate, precise and consistent manner throughout the study,” he said.
For these reasons, iCardiac’s proprietary methodology was developed specifically for optimizing study precision. According to Zapesochny, the methodology is based on nearly three decades of cardiac safety research, including in advanced digital signal processing techniques.
“Our technology enables our measurements to be extremely consistent and for us to utilize a lot more cardiac beats than what is used by traditional core labs (we use between 90 and 110 beats, while traditional labs usually use only 9 beats),” he said. “Our methodology drives considerably better precision, which reduces the possibility of an inconclusive or false positive study result.”