ArisGlobal updates adverse event reporting platform

Available as a web-based portal or mobile app, the platform – LifeSphere Mobile MA – allows users to access approved product content, report potential adverse events (AEs), and submit medical inquiries and product quality complaints, according to the cloud-based software solutions provider.

“To ensure compliance with regulatory directives, all life sciences companies need to provide robust and efficient processes for reporting and evaluating adverse events and product complaints​,” Simon Sparkes, executive vice president, ArisGlobal, told Outsourcing-Pharma.com.

According to Sparkes, self-service capabilities are becoming increasingly important because of changing technology trends and the expectation to provide immediate information.

“For many companies, the current mechanisms for reporting and evaluating adverse events and product complaints are laborious and time-consuming, which often discourages healthcare professionals, patients and internal field-based teams from reporting​,” he said.

FDA and EMA update adverse event reporting systems​

To address many of these issues​, both the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have both made changes​ to improve adverse event tracking.

The EMA today launched​ its a new and improved version of EudraVigilance, the agency’s information system of suspected adverse events.

The launch of the new system, which tracks events related to medicines that are authorized or being studied in clinical trials in the European Economic Area (EEA), involved the transfer of more than 11m individual case safety reports from clinical trials and post-authorization, the agency said.

According to the EMA, “the new system makes it easier for marketing authorization holders and sponsors of clinical trials to report suspected adverse reactions and allows for better analysis of this information for the benefit of patient safety in Europe​.”

Stateside, the US Food and Drug Administration (FDA) also recently launched an online tool to improve access to adverse event information for consumers, providers, and researchers.