In Vitro & In Vivo Cardiovascular Safety Assessment
Advance your lead candidates quickly with comprehensive end-to-end cardiovascular (CV) safety testing. From discovery to regulatory submission, Covance partners with you to develop, de-risk and execute on your stand-alone or integrated safety assessment program, enabling faster and smarter decisions.
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.
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.
Traditionally compounds with a hERG signal are quickly removed from the drug development pipeline; however, not all hERG blockers are proarrhythmic. Recognizing this opportunity, the FDA has pivoted beyond hERG- and QTc-centric testing to encourage a broader assessment of cardiac ion channels and human iPSC-derived cardiomyocytes. Covance offers these assessments and others to help you identify issues earlier in discovery that might impact your development program. Contact us.
Covance has been providing excellence in GLP telemetry studies for more than 15 years with study director tenures averaging 10+ 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.
Rely on our experienced team to partner with you to map your end goals and help you design your unique CV study plan. And your relationship with Covance doesn’t stop after you receive the final report. We provide risk assessment and data integration services to help you make informed decisions and prepare for regulatory filings. Partner with us to receive a fully integrated risk assessment report of your ion channel, stem cell, CV telemetry and toxicology data in context with your projected human exposure profile to enable a clear picture of potential CV risk. This Covance-authored text comes ready for direct import into your regulatory documentation – saving time and effort.
You’ve partnered with Covance in the past to expand your in vivo CV team. Now, gain access to world-leading in vitro cardiac laboratories through our partnerships with B’SYS and Clyde Biosciences:
B’SYS offers access to proprietary ion channel cell lines to deliver automated and manual patch clamp electrophysiology studies, including the ability to conduct the FDA’s CiPA protocols. From automated screening through GLP-compliant testing, B’SYS will enable your early discovery decisions through regulatory submission.
Clyde creates a complete cardiac safety profile through measurement of action potential voltage, contractility and intracellular calcium in human iPSC-derived cardiomyocytes. This assessment characterizes the net result of multi-ion channel inhibition in a fully integrated cellular system, providing leading edge translation to in vivo and the clinic.
When you place in vitro cardiac assessment work with us, you benefit from alignment with CiPA (Comprehensive in vitro Proarrhythmia Assays). All three partners are contributing members of CiPA working groups, evolving approaches as the paradigm continues to develop.
Cardiovascular safety is one of the most common roadblocks in your development efforts. To help you obtain the CV endpoints you need, we offer a comprehensive array of technology options including standalone or integrated as part of your toxicology study:
- GLP CV assessment with Physiotel™ L-series telemetry instrumentation
- Cardiovascular data acquisition on toxicology studies:
- Jacket-free ECG and hemodynamic data collection with minimally invasive Physiotel™ M-series technology
- Jacketed external telemetry (JET™), also available with blood pressure (JET-BP)
- Non-GLP investigative CV assessment:
- Rodent PhysioTel™ HD-series telemetry
- Non-rodent telemetry with L-series instrumentation
All telemetered ECG data generated at Covance is processed with automated software by our Centralized ECG analysis team. This dedicated group of scientists ensures a high quality and consistent analysis of your ECG data, with decades of experience interpreting cardiac arrhythmias and abnormal waveform morphologies.