Life Sciences Cardiac Monitoring Clinical Trials
Ensure cardiac safety, compliance and cost effectiveness with SGS cardiac monitoring clinical trials and thorough QT trials (TQT).
Early phase monitoring for a drug’s potential cardiovascular effects is crucial and may enhance cost-efficiency in the development process. Complying with the ICH E14 guidelines, which addresses QT interval safety evaluation, is key. The Food and Drug Administration (FDA) routinely reviews ECGs from cardiac safety studies conducted by Pharma. These cardiac safety studies typically include the collection of thousands of ECGs with particular focus on the QT interval.
Why use cardiac monitoring in clinical trials at SGS?
We can help you:
- Gain accurate cardiac safety evaluation
- Comply with the latest regulatory guidelines – such as FDA, ICH, 21 CFR part 11 compliance
- Benefit from unmatched reading accuracy and low variability (intraSD < 1 ms, interSD < 2ms), enhancing statistical power and allowing reduction of subject sample size and study cost
Trusted cardiac monitoring clinical trials from a world-leading provider
As an early phase drug development specialist, we perform several TQT studies each year, with an average of 24,000 ECGs per trial. With worldwide recognized partners, specializing in cardiac data reading (ECG/Holter), we have strong expertise in providing high-quality ECG reading and analysis in QT prolongation and safety pharmacology studies for the pharmaceutical and biotech industries.
Our high care unit is equipped with centralized Draeger Cardiac Monitors to continuously monitor heart rhythm and the complete set of vital signs. 32 beds are equipped with Draeger Telemetry, linked to the same centralized reading system.
Contact us today to learn how we can help with your cardiac monitoring clinical trial.