Individual Case Safety Reports must be compiled for each instance of a suspected or confirmed adverse event and each reception of a report about one.
Expedited Reporting or ICSRs (individual case safety reports) refers to a serious and unlisted event (an event not described in the drug's labelling) that is considered related to the use of the drug.
In most countries, the timeframe for reporting expedited cases is 7/15 calendar days from the time a drug company receives notification (referred to as "Day 0") of such a case. Within clinical trials such a case is referred to as a SUSAR (a Suspected Unexpected Serious Adverse Reaction). If the SUSAR involves an event that is life-threatening or fatal, it may be subject to a 7-day "clock". Cases that do not involve a serious, unlisted event may be subject to non-expedited or periodic reporting.
We have the systems in place to manage your ICSRs. We are able to manage your existing safety data as well as managing your future and ongoing requirements for processing ICSRs.
Our qualified team are able to review MedDRA coding and provide a full assessment of all cases, with secondary QC. Our fully qualified users of EudraVigilance for electronic reporting can then manage the subsequent submissions.
Compliance and tracking is integral to this service and our Regulatory Intelligence group are there to ensure that we are ahead of the game with any regulatory changes.
As with anything that we do, we understand that timeliness is essential and we are open to different models to work within your existing best practice.
If you want to dicuss how you can be safe in our hands, please contact us for a consultation.
Telephone: +353 125 44033