Complete Guide

Automation in Pharmacovigilance

Pharmacovigilance (PV) is a crucial drug development function that ensures the safety of medicinal products.

Learn how automation in pharmacovigilance delivers immense benefits to pharmaceutical, biotech, clinical research, and medical device companies, and global health authorities.

Introduction

PV Automation

Pharmacovigilance (PV) is the function in drug development that ensures safe and high-quality medicinal products are released to the market. The World Health Organization describes how PV achieves this through “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem.”

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?

Artificial intelligence (AI), machine learning, deep learning, natural language processing – in short, cognitive computing, is changing the pharmacovigilance world as we know it. Every day, more and more organizations are realizing the powerful impact on the quality of work and the speed at which manual tasks can be accomplished.

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.

LifeSphere Medical Information
By building AI into adverse event case processing (focused on tasks such as automated duplicate check, coding, validity assessment, and triage) and allowing pharmacovigilance resources to focus on strategic activities, life sciences companies can realize better outcomes. That’s because safety departments can work smarter and faster with reliable data at their fingertips.

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.

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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.

 

 Survey Results

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.

 

30% More Efficiency

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. 

 

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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.

 

LifeSphere MultiVigilance

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.

 

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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?

 

Get Ready

“It is not enough to say ‘I am going to build a new safety system.’ You need deep expertise and an intimate understanding of the regulations. It has to be tested over time with an organization that has delivered it for several years.” 
Aman Wasan

VP, Global Client Partners, ArisGlobal

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

LifeSphere MultiVigilance 10 is the next-generation safety system from ArisGlobal. It combines artificial intelligence (AI) with robotic process automation (RPA) to help organizations streamline adverse event case processing and medical review, substantially reducing manual effort.  

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.

“This transformational work will fundamentally improve health outcomes and positively impact mission performance.” 
Sean Chaffee

Booz Allen Hamilton, FAERS Program Lead

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.

WEBINAR
Managing and Mastering Pharmacovigilance: The SMB Perspective

When we talk about pharmacovigilance (PV) in Small to Medium sized Businesses (SMBs) there are specific challenges. The webinar covers how LifeSphere Safety benefits small to medium-sized businesses by utilizing industry-standard practices and proper management processes.

WHITEPAPER
Regional Pharmacovigilance Regulations: Challenges with Non-Harmonized Regulatory Expectations

With the increasing global awareness in safety reporting, the volumes of ADRs in MAH/national/global databases are also expected to increase at the same time. To derive meaningful insights from these huge volumes of safety data, it is important that the ADRs obtained from various sources are compiled and collated in a meaningful manner.

BLOG
ArisGlobal’s LifeSphere MultiVigilance 10 Helps SMBs Manage and Master Pharmacovigilance

Managing and Mastering Pharmacovigilance covers how LifeSphere Multivigilance 10 benefits small to medium-sized businesses by utilizing industry-standard practices and proper management processes.

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