Presentations shed light on effective, efficient cardiac safety assessment in clinical trials
PHILADELPHIA – October 22, 2018 – ERT, a global data and technology company that minimizes uncertainty and risk in clinical trials, today announced that its scientists have been invited to present several sessions at the Drug Information Association (DIA) Cardiac Safety Workshop in Japan. The workshop takes place October 25-26 in Tokyo.
The workshop’s objective is to gather clinical, industry and regulatory experts for discussions on a range of topics related to evaluating the cardiac safety of new drugs during clinical development.
Representatives from ERT have been invited to present the findings of their current research on effectively evaluating cardiac safety during clinical trials. Their presentations include:
- “Experience from QT Assessment Using Concentration QTc Modeling of Early Phase Studies” Borje Darpo, MD, PHD, ERT
- “Can we rely on Automated ECG Machine Measurements for Clinical Trial Decisions?” Robert Kleiman, MD, ERT
- “Heart Rate Correction When the Drug Affects Heart Rate” Georg Ferber, Statistik Georg Ferber GmbH and Randy Brown, ERT
- “Evaluation of a Proposed Novel Biomarker, the JTpeak Interval, for Evaluation of Proarrhythmic Liability” Borje Darpo, MD, PHD, ERT
“This is an exciting time in clinical development – with new research helping to evolve regulatory guidance on the most effective and efficient ways to conduct cardiac safety assessments during clinical research,” said Borje Darpo, MD, PHD, Chief Scientific Officer, Cardiac Safety, ERT. “My colleagues and I look forward to participating in this important event and interacting with other researchers to discuss the current state and future directions of cardiovascular risk assessment.”
Click here for more information on these presentations or for more information on ERT’s research into evaluating cardiac safety during clinical trials and its cardiac safety solution, visit ert.com/cardiac-safety.
About ERT ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that its customers can move ahead with confidence. With nearly 50 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so it can adapt without compromising standards. Powered by the company’s EXPERT ® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement and measure the efficacy of new clinical treatments while ensuring patient safety. In 2017, ERT supported more than 60% of all FDA drug approvals. Pharma companies, biotechs and CROs have relied on ERT solutions in 13,000+ studies, spanning more than three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly ─ and with confidence.