This is the first 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 better.
Together with advanced computing technologies like artificial intelligence in pharmacovigilance systems and processes, the life sciences industry as we currently know it is facing digital disruption that will create major transformation for the better…and more changes are on the horizon. These changes represent a disruptive shift to the traditional manner of processing data. In particular, Drug Safety/Pharmacovigilance is going through a paradigm shift, as technology developers are incorporating modern infrastructure, as well as robotic and cognitive automation capabilities, to redefine the end-to-end activities in safety case processing.
Pharmaceutical Companies & Service Providers: How well are you prepared for the change?
The huge potential to alleviate the impact of increasing adverse event case volumes is driving pharmaceutical companies to challenge internal processes to incorporate these technological advancements. For service providers (CROs/KPOs/BPOs), who are under constant pressure to deliver annual cost reductions, these technology advancements can be the holy grail to increasing productivity while reducing costs. With all these moving parts, it is imperative that the overall industry-preparedness level, including those of regulators, be raised.
Below are some of the key areas that pharmacovigilance departments and service providers should focus on to achieve to ensure preparedness for this change:
- Aim to minimize costs associated with current safety database infrastructure, including maintenance costs, by capitalizing on shifts to multi-tenant and SaaS models
- Move away from highly customized processes and adopt industry-leading, highly efficient, standardized processes, eliminating the burden on internal teams to maintain complicated customizations
- Implement forward-thinking processes and practices that take automation into account, and can scale to handle changing case volumes
- Understand the regulatory perspective of how cognitive computing and automation will be governed
- Train existing resources and provide them with an updated skill set to better prepare them for revised job responsibilities as intelligent automation will displace previous manual tasks
Technology Solution Providers: Recalibrating the Client-Vendor Model
Leading Safety solution providers, like ArisGlobal, who are incorporating state-of the-art technologies and software development methodologies, will be the key drivers of this transformation. Just like pharmaceutical companies and service providers, technology solution providers will need to recalibrate the traditional client-vendor model. Their focus should be on:
- Creative pricing models that reflect evolving market demands: working closely with pharmaceutical companies to build a comprehensive return on investment (RoI) model as a result of automation within Pharmacovigilance processes
- Reduction in implementation and upgrade cycle times
- Addition of change management and organizational readiness services as key focus areas
- Leading the drive from customized to standardized workflows and processes, etc.
In our concluding blog in this series, to be published in late March, we will share examples of use cases to showcase how these advanced technologies are already transforming drug safety as we know it.
Using ArisGlobal’s LifeSphere MultiVigilance as an example, we will share how automation functionalities built with combination of artificial intelligence (AI) with robotic process automation (RPA) can help organizations streamline case processing, substantially reducing manual effort to give companies cost savings of up to 50%, realized by higher data quality and compliance.