So you found a potential safety signal in Eudravigilance EVDAS… now what?
The EMA introduced and made available (to MAH’s and national competent authorities) the Eudravigilance Data Analysis System (EVDAS). This is great for companies and agencies who need advanced signal detection for post market surveillance. Included in EVDAS are tools to review case counts by demographics and even disproportionality analysis algorithms available for data scientists.
Once your organization identifies a signal, then, to comply with Module IX Signal Management, you must pursue the signal and track your activities. Many organizations have experience with a signal management tool as either bundled with the in-house signal detection platform or most commonly just an Excel spreadsheet. Yet with EVDAS, there is no included signal management component.
At Orbit, we provide an online Module IX compliant signal management solution. Your organization can track all signals, activities, meetings, and even documents pertaining to your safety signal processes. So when you are searching for potential signals in EVDAS and need to start managing the upcoming tasks, take a look at the Safety Signal Tracker from Orbit.