Forget (Almost) Everything You Know About Pharmacovigilance
Are you ready for next-generation PV technology?
Next-generation pharmacovigilance (PV) technology is going to disrupt old school approaches and outdated processes that haven’t changed in years. This disruption may be painful, but it is necessary, and the organizations and PV experts who are willing to adapt, stand to gain substantial benefits.
As anyone who has been through a system evolution knows, new technology always has a business impact. The business inevitably embraces these technologies -- but only after shedding a lot of blood, sweat and tears.
The current PV evolution will be no different.
Despite incremental improvements across the biopharma landscape, PV organizations haven’t seen any groundbreaking technology changes for decades. There have always been teams dedicated to getting data into and out of systems, authoring aggregate reports and verifying medical accuracy and completeness among other tasks. But most efficiencies were sought through outsourcing and piecemeal automation rather than the deployment of new technology. Today, this is no longer enough.
The PV Playbook
Steady changes in the PV environment, including a more complex regulatory landscape, increasing globalization, and a rising number of unstructured data sources to translate and review, are changing the PV playbook. Companies must adapt their processes to stay compliant – affordably. Outsourcing can no longer drive sufficient efficiency to keep costs down and productivity up. Automation needs to be the norm, not an add-on.
Automation and Innovation
At the front-end, extreme automation and natural language processing (NLP) are starting to add huge benefits, making it possible to get data into safety databases with virtually no human effort required. NLP and automation tools can read source documents and identify relevant information to build clinically robust auto-narratives, thereby eliminating the need for labor intensive data entry and authoring. This cuts time and cost while reducing the risk of errors.
Further into the process, artificial intelligence and machine learning increasingly will be used to identify patterns within structured and unstructured narratives, which will soon negate the need for routine reviews of single cases and manual efforts associated with identifying and validating signals.
Throughout the process, dynamic configuration management and distribution of patches are further reducing the need for manual attention related to system maintenance.
People are still integral to the process
All of these technical innovations eliminate much of the manual labor in PV activities, but that doesn’t mean they are eliminating the people-part of the process all together. Simply put, human effort will still be needed in most aspects of PV, but the day-to-day tasks will be more strategic than mundane.
For example, people whose jobs used to be entering and verifying data, authoring narratives or rekeying data will shift to new more strategic roles, capitalizing on employee knowledge and experience. Critical thinking skills will be essential for analyzing and interpreting the wealth of available data and deciding on optimal courses of action.
To succeed in these roles, current PV professionals must have open minds to the new ways of working. Arguably, this is one of the greatest challenges to transforming and positioning a PV organization for success with next-generation technology. Even if there is a “perfect” solution out there, its deployment won’t be successful if the organization does not embrace new ways of working and thinking about PV, and its people are not willing to let go of decades-old assumptions about how things should be done.
For those of you not yet moving forward into the new era of PV, it is time to throw out the old rulebook. The first step is to start talking about what this journey will look like for your organization, what this transformation process will involve, and who will lead the way. This transformation requires tremendous human touch to effect the right organizational change and PV leaders with the skills and support they need to get us there.
This brave new world won’t be for everyone. However, if PV leaders create a roadmap for change and carefully manage the business transformation process, team members will adapt and get excited about the future. Finding and fostering this next-generation team that embraces next-generation technology is the best way to position any PV organization to thrive in the future.
To learn more about how IQVIA can help you predictably and cost-effectively achieve your safety and surveillance goals visit iqvia.com/vigilance.
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