Whether your end-customers are pharmaceutical, medical technology or consumer package goods companies, they may be struggling to comply with Adverse Event Reporting requirements.
Adverse Event Reporting (AER) is a serious responsibility and compliance requirement for pharmaceutical firms. It can also be a real administrative burden. An adverse event is defined as:
“Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment.” [from Farlex partner Medical Dictionary and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use,]
The U.S. Food & Drug Administration (FDA) requires pharmaceutical firms to file Adverse Event Reports to the FDA within 24 hours of becoming aware of the event (which can be extended up to 72 hours during holidays). This means they must have rigorous processes for monitoring, data integration, and compliance. It requires both medical and coding expertise, and a broad enough team to span the globe and react quickly.
Good news: you don’t have to go it alone.
Ascribe Solutions specializes in adverse events reporting, regardless of the type of research or subject. We read –and will report upon– adverse events in products that are in clinical trials, or any of your pharma clients’ products or medical devices that are currently available either OTC or by prescription.
Our readers are unique in the market research world. We specialize in adverse events done by real nurses and medical professionals, assuring compliance with all pharmaceutical firm requirements and certifications.
With Ascribe Solutions, Market Research firms can feel confident in correct reading and reporting, all within the stringent read-time regulations.
We conduct extensive training both internally and externally, and maintain annual certifications by major pharmaceutical firms as well as the British Healthcare Business Intelligence Association (BHBIA), which the UK and other countries use as their standards for Adverse Events. With a team of professional nurses and close relationships with the pharmaceutical firms, we are the go-to group in the industry for AER.
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