Drugs that prolong the QT interval on an electrocardiogram (ECG) can cause dangerous arrhythmias, such as Torsade de Pointes (TdP), which can be fatal. Assessing and mitigating these risks can save lives. The QT interval measures the heart’s electrical reset time between beats. Disruptions can lead to serious health issues, so it’s essential that drugs do not negatively impact this process.
Thorough cardiac safety evaluations are required for drug approval. Failure to meet these standards can delay or halt development, preventing potentially life-saving drugs from reaching patients. Comprehensive cardiac safety assessments help pharmaceutical companies demonstrate their commitment to safety, maintaining the trust of patients, healthcare providers, and regulatory authorities.
At CRS, we rigorously assess potential cardiac risks to ensure our drugs are both effective and safe for those who need them.
Given its sensitivity to heart rate, our experts critically analyze the corrected value of the QT interval (QTc) during drug development trials.
Most drugs undergo standalone Thorough QT (TQT) trials, which are integral to comprehensive evaluations of their pharmacokinetic (PK) and pharmacodynamic (PD) properties. These trials are pivotal for understanding how drugs affect QT/QTc prolongation in relation to their concentration in the body.
Careful study design, including the timing of ECG readings and PK sampling, improves the accuracy of these assessments.
To streamline the drug development process, we implement cutting-edge techniques endorsed by ICH E14 guidelines. These guidelines, established by the International Council for Harmonisation (ICH), provide a standardized approach to evaluating QT interval prolongation potential in new drugs.
Our advancements allow for early identification of QT prolongation risks through intensive ECG analysis and exposure-response modeling, potentially avoiding the need for traditional Thorough QT (TQT) trials.
We collaborate closely with leading ECG providers and utilize state-of-the-art technologies to ensure the highest quality data. Our services extend beyond TQT studies to include strategic advice, PK/PD modeling, concentration QT analysis, medical writing, and regulatory affairs support.
With a proven track record of approximately 3–5 cardiac safety trials annually, including 12 TQT trials compliant with ICH E14, CRS maintains rigorous standards. Our facilities are specifically designed to minimize errors, providing a controlled environment crucial for accurate cardiac safety assessments.
We are dedicated to advancing cardiac safety in drug development through meticulous research and state-of-the-art methodologies. By leveraging our expertise and infrastructure, we facilitate the safe progression of novel therapies while mitigating risks associated with QT prolongation.
Contact us today for more information on how CRS can support your cardiac safety trials.