Cardiac Safety Assessment_Elixir Clinical Research

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Cardiac Safety Assessment

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Cardiac Safety Assessment

The Importance of Cardiac Safety Assessment

Cardiac safety is one of the key considerations in early clinical safety assessments, which is of great significance for the implementation of subsequent trials, whether the drug can be successfully approved for marketing and whether it has the risk of market withdrawal after marketing
E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs issued by International Council for Harmonisation (ICH) has been officially implemented in China and has been widely used by sponsors in various countries
To conduct blind and independent central ECG readings efficiently and accurately, reduce data bias and variability, enhance the accuracy and reliability of the reading results, accelerate the trial process and approval, and reduce costs

Scope Of Services

Provide A Comprehensive Solution For Early Clinical Cardiac Safety Assessment

Study Operations

Complete C-QT program experience

Well-established integrated solutions for central ECG reading

· FDA certified professional ECG acquisition equipment and analysis system to meet international filing requirements

· Online operation throughout the project (eImage system embedded with E-Scribe/H-Scribe ECG analysis module), ensuring traceable operations, compliance and high efficiency

· Team of authoritative and experienced experts from TOP tertiary hospitals for reading services

· Excellent project management team for proactive risk management and control

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