Case Study

Bioclinica Cardiac Safety Services Offered a Unique Solution for a Specific Regulatory Requirement ~5 180 21 >2000

Bioclinica Cardiac Safety Services Offered a Unique Solution for a Specific Regulatory Requirement ~5 180 21 >2000

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Bioclinica.com/contact 1 CASE STUDY Bioclinica Cardiac Safety Services Offered a Unique Solution for a Specific Regulatory Requirement Introduction To ensure patient safety, outcomes related to cardiac safety are important for drug development across all therapeutic areas. As such, measurements related to QT interval prolongation and proarrhythmic risk are mandated by regulatory authorities. Furthermore, monitoring of off-target effects on cardiac function with some drugs (e.g., oncological and neurological drugs, among others) might be required for submission. Particularly in these situations when the equipment and expertise to monitor cardiac function might not be available in specialized clinics, cardiac safety services can prove useful. They traditionally include standardized

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