Charles River enables sponsors to efficiently meet scientific and regulatory requirements for cardiac safety assessment in small molecule and biological drug development. Our dedicated cardiac studies team has achieved excellent performance, including cardiac monitoring during first-in-human studies, ECG-intensive studies and thorough-QT (TQT) studies in accordance with E14 guidance.
Study types
- First-in-human
- ECG-intensive
- TQT
- Ambulatory blood pressure monitoring (ABPM)
Safety is our priority at Charles River. We provide 24/7 ACLS nursing support and investigator oversight. Regional Medic I emergency can respond within five minutes, and there are two local hospitals within three miles of our site.
Charles River collaborates with sponsor-selected ECG core laboratories and has developed seamless processes for communication and data transfer. In 2009, the rates for successful ECG extractions at scheduled time points in TQT studies of 54-250 subjects for our core laboratories were above 97%.
Charles River is a certified partner of Mortara Instrument. We use Mortara Eli 250 12-lead ECG machines and the Mortara X-12 Surveyor system. The Surveyor telemetry system enables continuous 12-lead ECG data recording for up to 64 study participants simultaneously. These systems are technically compatible and can be used in parallel with Mortara H12+ Holter devices, when required by sponsor protocol or upon request.
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Cardiac safety trials, clinical trials, clinical studies, cardiac safety assessment, cardiac monitoring, first-in-human, ECG-intensive clinical studies, thorough-QT, TQT studies, E14 guidance, cardiac studies, Ambulatory blood pressure monitoring, ABPM, ECG core laboratories, ECG extractions, Mortara Instrument, Mortara Eli 250, Mortara X-12 Surveyor, telemetry, ECG data recording, Holter devices
Cardiac Safety Trials | Charles River Clinical Services
Charles River’s dedicated cardiac studies team has experience with cardiac monitoring during first-in-human studies, ECG-intensive clinical studies and thorough-QT (TQT) studies in accordance with E14 guidance.