This is the second in a two-part blog series that examines the key areas that pharmaceutical companies, service providers, and solution providers should focus on as technology advancements continue to transform drug safety for the future.
Read our first blog, “Are You Ready for the New Era of Drug Safety” for background information on this discussion.
Clinical safety is changing from a reactive role to a strategic role throughout the product lifecycle. This requires organizational changes and oversight. As case volumes increase, and tougher regulations are introduced that call for more stringent oversight by health authorities, the days of using those circumstances as a justification to request more staff to mitigate the increased workload of collecting and processing data are most likely gone. Today’s reality is one where pharmacovigilance/drug safety departments in life sciences companies are required to do more with less.
To succeed, organizational readiness now requires a mindset and plan to manage existing challenges and prepare for the unknown ones around the corner. As shared in our March 14 blog, there are many technology advancements – artificial intelligence (AI), natural language processing (NLP), deep learning, multi-tenant cloud, chat bots and more – that are or will disrupt the status quo way of thinking and working.
While artificial intelligence (AI) and natural language processing (NLP) will streamline adverse event case reporting for the better, providing up to an 80% increase in efficiency in case intake and data entry, that doesn’t mean that jobs and livelihoods will be lost as a result. Instead, as automation handles repetitive and routine manual tasks, safety departments can use this digital disruption to retool their workforce to address higher order activities such as case assessment, signal detection and risk management activities.
To get ready for the changes ahead, three key areas of focus need to be planned for and addressed:
Change Management
Without question, digital disruption will have an impact on your safety team, as any change means a new and different way of doing something. A Change Management plan must be implemented hand in hand with any proposed change to technology and supporting processes. Gaining the buy-in of your staff is critical, so spend time clearly articulating the purpose of the change and then connect that with their daily tasks and activities. Gain insight from colleagues in other companies who may be ahead of you in this transformation journey, learn from their mistakes and successes, and then adapt that insight to your organization’s culture.
Safety system/database solution providers such as ArisGlobal have created focused groups of life sciences companies that can discuss technological advances, prioritize critical business challenges and make quick decisions to address them with technology. This allows organizations to discuss change management planning in the context of process changes due to technology enablement.
Training
Deploying new software into an organization or department stands a better chance for success when proper training is part of the planned rollout. Helping your staff understand how the new technology / software will improve their work and productivity, and contribute to improved patient outcomes is a good start, but it takes time for people to adjust to changes in their daily work routine. Letting go of familiar processes and learning new behaviors can be hard for some, so giving your staff the time to get properly trained by professional trainers is an essential piece of any plan involving the disruptive change agents discussed in our previous blog. Of course, training and employee success will be achieved faster if the software vendor has created a comprehensive training curriculum leveraging a mix of interactive online training materials and instructor-led sessions that can be delivered in an agile manner, coordinated with the introduction of new processes.
Learning Development
Finally, building a company that can respond positively to change requires a learning and development strategy built around a framework and plan for re-tooling the capabilities and skills of your team to meet your organization’s business strategy. As LifeSphere MultiVigilance’s automation capabilities help eliminate manual data entry and streamline processes, it’s important to help your staff recognize they will have time for more value-added responsibilities that will make them better qualified to meet the challenges ahead. By providing them the learning and development necessary to undertake what will become new areas of personal growth — case assessment, signal detection and risk management activities – your pharmacovigilance department stands a stronger chance of meeting the demands for the new era of drug safety.
The New Era of PV is upon us and novel technologies have the potential to transform drug development processes, automating routine and repetitive manual tasks. With these changes, highly-trained staff can focus on higher value work, consequently replacing certain transactional roles. Have questions on this topic? We invite you to learn more by viewing our on-demand webcast, “Practical Use Cases of Automation in Pharmacovigilance and Regulatory to Achieve End-to-End Productivity.”
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