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Improving Adverse Event Reporting Processes

Adverse event (AE) reporting is one of the cornerstones of pharmacovigilance teams.  By tracking AEs, pharmacovigilance teams can improve the safety profile of a product before and after launch.  Although AE reports are an effective way to uncover unknown side-effects of a product, teams still seek to better some aspects of the AE reporting process.  Cutting Edge Information’s Pharmacovigilance report explores some ways in which surveyed teams would like to refine the AE reporting process.

Figure 1 shows the improvements that surveyed teams would like to see in the adverse event reporting process.

  • The largest percentage of all teams (56%) would like to improve the level of detail that external groups provide in adverse event reports. AE reports without enough context often require a follow-up from pharmacovigilance teams.  Therefore, enhancing the level of detail provided in reporting an AE can help save valuable time.
  • A quarter of all teams, along with similar percentages of global and country-level teams, would like to establish a liaison between external groups and in-house pharmacovigilance staff. A single point of contact for both groups could help pharmacovigilance teams consolidate the large number of AE reports that they receive and in turn save these teams even more time.
  • Sixteen percent more surveyed global teams (36%) would like to alter the frequency of communication with external groups than country-level teams (20%).
AE Reporting blog
Desired Adverse Event Reporting Process Improvements, by Team Level

Figure 1: Desired Adverse Event Reporting Process Improvements, by Team Level

While the figure above addresses some key improvements that teams would like to see, there still remains a number of different approaches to better the AE reporting process.  These approaches may include developing more straightforward AE reporting structures or formalizing channel specific AE reporting guidelines.  Despite using different methods, the goal remains the same — simplifying the AE reporting process for external groups and supplying pharmacovigilance teams with sufficiently detailed AE reports.

To learn more about the research findings in Cutting Edge Information’s Pharmacovigilance report, download the report summary here.

Todd Middleton
Research Analyst
919-433-0213


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