Complete Guide
Automation in Pharmacovigilance
Learn how automation in pharmacovigilance delivers immense benefits to pharmaceutical, biotech, clinical research, and medical device companies, and global health authorities.
Introduction
PV Automation
Though specific PV processes can vary from organization to organization, there are global requirements that must be addressed, including signal detection, risk management, adverse event reporting, and other activities. Some of these processes create repetitive, manual tasks, which often are not only time-consuming but also extremely costly for the organization.
Utilizing automation technologies – including natural language processing and machine learning – to streamline manual PV processes enables organizations to realize greater efficiency, while freeing up precious resources to allow drug safety teams to focus on higher order tasks.
Automation needs to impact the end-user in a positive manner. When looking at the automation journey, this has to be top of mind.
Automation needs to be real, timely, and useful. When thinking of automation, make it friendly and non-disruptive to your processes.
The deeper the industry expertise, the better the automation outcomes will be. Work with experts to get the best results. This is especially true with PV automation.
What is Automation in Pharmacovigilance?
As its use cases further develop, automation promises to be a game-changer in pharmacovigilance, decreasing the cost of case processing and improving data quality to allow area experts to focus on areas where they truly add value, including signal detection in drug safety, pharmacovigilance analytics, and benefit-risk assessment.
Repetitive and routine manual tasks such as adverse event case intake and data entry can be automated and tackled by AI in a sophisticated and seamless way. These tasks, for which we have coined the term “pharmacodiligence” – in other words, the due diligence of collecting and processing data – are not strategic in the same way as activities such as benefit-risk assessment.
ArisGlobal’s LifeSphere MultiVigilance is the industry’s first end-to-end safety system with production-ready automation. We’ve developed this solution hand-in-hand with leading life sciences organizations, ensuring that it’s ready to tackle real-world automation use cases out-of-the-box. LifeSphere MultiVigilance leverages cognitive computing technologies such as natural language processing and machine learning and provides a single, global database that supports automation of all adverse event processing.
LEARN MORE ABOUT
Automation in Pharmacovigilance
Areas to Automate
Automation of PV-related processes can take many forms. In a recent survey, nearly half of the respondents reported a desire to move toward end-to-end case processing automation. Case intake was ranked as the top priority workflow step to automate by nearly 25% of respondents. Duplicate check also ranked highly with one-fifth of those surveyed.
Benefits of Automation
Automation brings substantial benefits to daily PV activities, including time savings on repetitive tasks and decreasing costs. For certain customers, we’ve seen immediate 30% efficiency gains in case processing.
Other benefits include increased case processing quality and error reduction thanks to natural language processing and cognitive computing.
Learn more about our production-ready automation capabilities.
Our Approach to Automation in PV
ArisGlobal has taken a priority-based approach to PV automation use cases. We started by solving the automation of case intake, and then focused on associated steps including data entry, coding, case assessment, and quality review. We then built automation for medical review, causality assessment, follow-ups and language translation. Finally, we focused on developing touchless workflows for end-to-end automation of less complex adverse event cases.
Practical Automation Use Cases
Building LifeSphere MultiVigilance in close partnership with industry leaders such as the FDA, puts our solution at the forefront of automation-readiness.
Organizations can leverage machine translation for multi-region case processing, while automated case intake and data extraction delivers significant time savings, and built-in validity, triage, and duplicate check automation let safety teams focus on more important tasks.
Learn more about LifeSphere MultiVigilance’s automation use cases.
Production-Ready Automation
There is a significant amount of hype around Artificial Intelligence and its ability to augment pharmacovigilance teams. The reality, however, is that many vendors have been unable to deliver upon their early automation promises.
ArisGlobal took a pragmatic approach to automation, opting to work directly with its customers to develop, test and fine-tune real-world use cases. The result is that LifeSphere MultiVigilance is the life sciences industry’s first end-to-end safety system with production-ready automation. Built hand-in-hand with the industry, it’s ready to deliver significant efficiency gains out-of-the-box.
Organizational Readiness
The life sciences industry has seen a flurry of news and information touting the benefits of automation. Not all companies, however, are ready and able to implement the substantial changes necessary to deploy automation.
ArisGlobal understands this, and has developed a full-service Organizational Readiness offering, designed to help our customers manage change at scale.
When thinking about the addition of automation to your pharmacovigilance environment, is your organization ready?
RESULTS
Delivering Results From Day 1
80
%
Of Top 50 Biopharmas
80% of the top 50 biopharma companies are our clients
80
%
Efficiency Gains
80% potential efficiency gains driven by our Nava cognitive computing engine
30
%
Cost Savings
30% immediate cost savings potential via our advanced automation capabilities
100
%
Compliance
100% compliance with all present and upcoming regulatory standards
Artificial Intelligence and Robotic Process Automation at Work
This new platform is transformative for the FDA in its ability to automate key processes, incorporate the latest safety data standards and improve productivity, allowing reviewers to focus on public health and patient safety.
PRESS RELEASE
LifeSphere® MultiVigilance 10, the Industry’s First End-to-End Safety System with Production Ready Automation
FACT SHEET
Next-Generation Platform for
Intelligent, Automation-Enhanced Adverse Event Management
LifeSphere Safety is a multi-tenant, cloud platform that leverages cognitive computing to support global pharmacovigilance, clinical safety and benefit-risk management programs.
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