individual case safety report (ICSR)

E2B Gateway Speeds AE Submissions to Regulatory Authorities

Our Argus Safety Team recently worked with the FDA to implement an E2B Gateway which allows our global safety team to submit clinical trial individual case safety reports electronically.  This provides a means of compliant filing which alleviates time pressure, allowing safety scientists and the medical review teams to do what they do best -- evaluate Adverse Event reports. The Pharmacovigilance staff also can process more reports in less time, allowing for increased time for medical review and setting the stage for increased case volume potential.

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