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Experience a seamless progression of your compounds from in vitro cardiac assessments through GLP-compliant in vivo CV studies with a partner who brings the breadth of assays and expertise you need.
You want to identify CV risks early
Early in vitro screening allows identification and reduction of cardiac risk prior to advancing to later, more laborious and expensive, in vivo testing. Our team works with you to custom design an in vitro CV de-risking package that goes beyond hERG to enable faster, smarter decisions and to select the best compounds to move forward. We offer patch clamp assessments of cardiac ion channels including hERG, Cav1.2, Nav1.5 peak and late and seamlessly partner Clyde Biosciences to provide human iPSC-derived cardiomyocytes action potential testing to help you identify issues earlier in discovery.
You need a comprehensive CV package
Cardiovascular safety is one of the most common roadblocks in your development efforts. Rely on our experienced team to partner with you to map your end goals and help you design your unique CV study plan. We have been providing excellence in telemetry studies for more than 15 years. Our dedicated telemetry facilities enable data collection in a quiet and undisturbed environment, producing industry-leading data quality and assay sensitivity. Whether you are conducting a core battery GLP telemetry study or requiring collection of cardiovascular data on a toxicology study, rely on our experienced staff to design and conduct your studies using cutting-edge technology in our state-of-the-art facilities.
To help you obtain the CV endpoints you need, we offer a comprehensive array of technology options
- Large animal PhysioTel™ L-series telemetry
- Rodent PhysioTel™ HD-series telemetry
- Cardiovascular data acquisition on toxicology studies:
- Jacket-free ECG/hemodynamic collection with PhysioTel™ M-series technology
- Jacketed external telemetry (JET™), available with blood pressure (JET-BP)
- Rodent and non-rodent echocardiography
All telemetered ECG data we generate is processed with by our centralized ECG analysis team. This dedicated group of scientists ensures high-quality and consistent analysis of your ECG data, with decades of experience interpreting cardiac arrhythmias and abnormal waveform morphologies.
You want to reduce your clinical ECG burden
With the release of the new ICH E14/S7B Q&As, for the first time, preclinical in vitro and ECG data can now be used to impact clinical ECG study design. Compounds that are deemed a low risk based on preclinical data (hERG and in vivo QT) allow sponsors more options to substitute the human thorough QT (TQT) trial with Phase 1 ECG data by leveraging preclinical in vitro hERG and in vivo QTc data, reducing the overall industry TQT burden for low-risk compounds. To take advantage of the new Q&As however, higher standards for conduct and reporting of the preclinical studies are required. In addition to establishing hERG Q&A capabilities, we have in place all the new quality standards for ECG Telemetry that demonstrate achievement of QTc sensitivity equivalent to that of the clinic. allowing you to apply the new guidance to your drug development portfolio.
