Safety Management/ Pharmacovigilance
We regularly review information throughout a study to proactively increase compliance, mitigate potential roadblocks, and ensure that all safety data is assessed and reported appropriately.
Trial Management Services to Meet Your
Safety Management/Pharmacovigilance Needs
Safety Management/Pharmacovigilance services offered by GLOBAL include:
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Adverse Event Adjudication including CEC development and management
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Safety Oversight including DSMB/IDMC development and management
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Adverse Event Coding
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Adverse Event Trending and Reporting
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Medical Monitoring
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Safety Reporting to regulatory authorities
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Safety Narratives
Why Choose GLOBAL for
Safety Management/Pharmacovigilance?
Proper safety oversight of your clinical trial is critical for both patient safety and to ensure all regulatory reporting requirements are met. GLOBAL has decades of experience in developing safety management plans to ensure an adequate safety profile for your product, and to ensure any trends or issues are spotted promptly. GLOBAL can create and manage safety boards as well as oversee event adjudication with top medical experts in your therapeutic area.