Local ICSR Management.
Patient safety – everywhere.
We offer complete support for the management of local Individual Case Safety Reports (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 Competent Authorities according to the applicable country-specific requirements like format, timelines, route of submission, etc.
We ensure that all cases that require additional information after initial review are rigorously followed-up back to their sources within any applicable deadlines.