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.
Your compound has a hERG signal
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. We offer these assessments and others to help you identify issues earlier in discovery that might impact your development program.
You need a comprehensive CV regulatory package
We have 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.
You need a cardiovascular assessment advisor
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 us 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 text comes ready for direct import into your regulatory documentation – saving time and effort.
In vitro cardiac assessment studies & CiPA protocols
When you need expanded support for in vitro cardiac safety studies, get the benefit of a CV team aligned with CiPA (Comprehensive in vitro Proarrhythmia Assasys). Our involvement with CiPA working groups offers new insight into evolving approaches as the paradigm continues to develop. We also partner with Clyde Biosciences to deliver a complete cardiac assessment solution.
In-house ion channel capabilities
- Manual patch clamp electrophysiology studies (hERG, Cav1.2, Nav1.5 peak and late)
- FDA CiPA protocols available