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Bioclinica Cardiac Safety Services Offered a Unique Solution for a Specific Regulatory Requirement

A small biopharmaceutical company that focuses on therapeutics in immune disorders was developing an oral therapy to treat relapsing multiple sclerosis. During the development of this therapy an off-target effect of bradycardia occurring up to 6 hours after the dose was identified. To meet regulatory requirements for phase 2/3 trials to evaluate efficacy and safety of the drug, heart rate (HR) needed to be monitored via ECG by a centralized lab for a minimum of 6 hours after the dose. After HR normalized at the 6-hour timepoint the patient could be discharged from the neurology clinic.

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