Case Processing (ICSRS)
What Is An ICSR? ‘ICSR’ refers to Individual Case Safety Reports, it is a result of the collation of information, received from a reporter, e.g., …
Expedited Reports
Did you know that EU Pharmacovigilance laws mean that ALL spontaneous reports regarding serious adverse reactions must be expedited within 15 days…
Medical Writing Reports
If companies have a marketing authorisation in the EU for their drugs, they are required to prepare detailed approval documents, on all their products…
Literature Screening
Why Are Correct Screening Procedures So Important? Regulators expect consistent screening to be an integral part of your day-to-day drug safety …
Safety Signals
Your Processing of Safety Signals for all drugs, involves the collection and processing of tremendous amounts of drug safety data…