According to the data and technology company, the center is the first significant cardiac safety service enhancement to leverage capabilities of iCardiac Technologies and Biomedical Systems, both acquired in 2017.
“ERT launched the Phase I QT Center of Excellence to give sponsors actionable and reliable information about the cardiac safety profiles of their compounds at the earliest possible time in the drug development process,” Alex Zapesochny, executive vice president, cardiac safety at ERT, told Outsourcing-Pharma.com.
The company will offer cardiac safety assessment in Phase I studies using its integrated ECG analysis platform, Expert Precision QT (EPQT), which was launched in parallel with the center.
Zapesochny explained the platform integrates iCardiac Technologies’ methodology for obtaining precise ECG data with ERT’s EXPERT technology platform.
“Accessing better cardiac safety information earlier allows pharmaceutical companies to make informed go/no-go drug development decisions, prioritize and package clinical programs with strong safety profiles and appropriately resource or refocus programs exhibiting potential cardiac safety issues,” he added.
The center also provides Method Bias Sensitivity (MBS) analysis and Agile Statistical Reporting (ASR) services from in-house statisticians.
The evolution of cardiac safety testing
Traditionally, assessing a drug’s effect on ECG parameter involves conducting a stand-alone Thorough QT (TQT) study near the end of Phase II or early in Phase III, Zapesochny explained.
“This means that definitive information about a drug’s cardiac liability isn’t known until quite some time into the clinical development process,” he said.
However, in December 2015 the ICH approved an alternative to TQT studies, which relies on ECG data collected during routine Phase I studies, and enables sponsors to seek a waiver from having to conduct a TQT study.
“Now that sponsors have an alternative to conducting an expensive TQT study, they’re increasingly discovering multiple other advantages to assessing QT early,” said Zapesochny
“These include being able to make better-informed decisions about prioritizing their pipelines based on cardiac risk, to leveraging this early cardiac safety information in discussions with investors or partners. Doing so can add significant value to their compounds.”