Suggestions to safety adverse event case data reporting

Suggestions to improve safety adverse event case data entry/evaluation and regulatory reporting

We provide consulting services for the analysis and proposal of operational improvements for the entry of adverse event case data in the Safety Information System, case evaluation, and individual case and aggregate reports to regulatory authorities.

In particular, we will introduce and support the introduction of systems and tools that are effective for automating Intake & Triage (including the use of AI) and improving operational efficiency, especially when cases are first obtained.

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