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Managing Adverse Events (AEs) During Fieldwork

We combine a robust and secure platform with compliance principles to deliver a seamless experience in monitoring and reporting AEs.

Adverse Events (AEs)

Partner with us on medical products and device market research, and make the most of our reliable monitoring and reporting system.

Our team of experts, supported by advanced monitoring technology, diligently check responses on a daily basis to ensure that nothing is missed.

By drawing upon years of expertise in healthcare market research, we have developed the ability to prioritise timely report generation without compromising on quality.

The m360 Research Difference

Share with us your reporting obligations, and we’ll make sure your requirements are incorporated in our project plans.

Expert Team: Leverage our expertise in verbatim coding, scientific writing, and AEs reporting.
Monitoring Technology: When it comes to programming, we can incorporate flags and triggers into surveys, for easier review.
24-hour Reporting: We always report within one business day directly to the sponsor’s pharmacovigilance department.

Adverse Events (AEs) Best Practices

Even though clinical trials aim to minimise AEs, they can’t be completely eliminated, emphasising the need for market researchers and fieldworkers to adhere to best practices when they emerge during research.

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Frequently Asked Questions (FAQs)

What is an adverse event (AE)?

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

What is the end goal?

Monitor and measure occasional harm from medication and whether the risk-benefit ratio is high enough to continue use of any particular drug.

What is the typtical timeframe for reporting?

AE notifications should be reported within one working day (24h) and if the data is collected over weekend, it can be reported on the next working day, within one business day of the team becoming aware of the AE.

Who can report?

Healthcare professionals and consumers, pharma companies, people or companies working for MAHs (Marketing Authorization Holders), the sponsor, or sub-contractors of the MRA.

What is the essential information that a report should include?

An identifiable patient, an identifiable reporter, product exposure, and a specific event.

Managing Adverse Events (AEs) During Fieldwork

Adverse Events (AEs)

Partner with us on medical products and device market research, and make the most of our reliable monitoring and reporting system.

The m360 Research Difference

Adverse Events (AEs) Best Practices

Frequently Asked Questions (FAQs)

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