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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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Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

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