Local ICSR Management.
Patient safety – everywhere.
We offer complete support for the management of local ICSRs, including but not limited to:
Safety mailbox management.
We can monitor, assess, track, process and forward any correspondence and information received in a local safety mailbox.
Local case submission.
We can process all local submissions to National CAs according to the applicable country-specific requirements like format, timelines, route of submission, etc.
Case follow-up.
We ensure that all cases that require additional information after initial review are rigorously followed-up back to their sources within any applicable deadlines.
Selected PV Case Studies.
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ICSRs, Local literature screening, Regulatory intelligence
Local literature search, ICSR processing, Regulatory intelligence
