The Big Picture in Safety, Part 2 of 4: Simplicity + Automation = Productivity: The Pharmacovigilance Equation for Managing More with Less
Oct 04, 2016
The second in our four-part series on the importance and opportunities of a Total Safety approach to pharmacovigilance explores productivity.
As with every other part of the business, pharmacovigilance departments are resource constrained and those resources are often stretched thin. They must cope with increased regulatory demands around drug safety and risk management with fewer staff members. They are expected to assess and act upon generalized safety topics, as well as conduct pharmacovigilance analytics to discern trends from data. And they must ensure critical information reaches all other connected functions – regulatory, quality, manufacturing, clinical development, post-authorization and marketing. The mandate from executive management is clear that they must find ways to improve productivity.
Automation is one important element in driving better productivity. For example, intelligent optical character recognition can significantly reduce data entry effort for structured forms – such as Serious Adverse Event (SAE) forms – by as much as 50%.
Another important element for improving productivity is a user-friendly interface, since this helps to drive higher user acceptance. A simpler, easier to use interface can speed case processing, enable better alignment of frequently used and captured data elements, and allow common entities such as person – reporter, patient, parent, investigator – to be grouped in logical ways. In a market with high employee turnover, a simple user interface can mean the difference between compliance and failure, as the users can train up more quickly, and more effectively capture the right information.
Importantly, productivity is enhanced when a solution is geared toward the needs of the user and the business rather than being IT-driven. That means enabling the super, or frequent, user to create, maintain and update rules as required, giving them greater control over how their processes and workflow are configured and eventually optimized.
With rapidly changing pharmacovigilance regulatory reporting requirements and an austere business environment, ongoing enhancement of productivity will depend on a solution that can be quickly configured to any new rules or developments and increases processing efficiency.
Contact ArisGlobal to learn about the recently launched TotalSafety 7.3, an innovative upgrade featuring technical and usability enhancements to the company’s leanest and fastest integrated suite of safety products.