Safety Management/ Pharmacovigilance
The GLOBAL CRO Approach
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.
Our Services 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 CRO?
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.
