Pharmacovigilance Automation

While the notion of using pharmacovigilance automation technology to enable transformation applies to all aspects of business, we are at a stage where innovative technology is a necessity to be relevant and enable a compelling business proposition.

Given the strategic role of pharmacovigilance (PV) systems and the growing numbers of safety data sources and AE reports, technology solutions are already a vital cog in safety operations. Companies that recognize the importance of integrating newer, disruptive technologies and use them to fundamentally alter the drug safety continuum will see greater success in managing the safety of their products and maintaining cost-effectiveness.

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Forging the Path Forward with Automation

PV automation tools range from basic to robotic process automation, to cognitive and artificial intelligence (Figure 1), offering a wide variety of technology solutions that can be utilized to drive operational efficiencies across the PV continuum. At Covance, we understand the benefits that these automation tools offer and how our clients can take advantage of them.

The PV automation roadmap

Figure 1 – Covance PV Automation Tools and Roadmap

Basic Automation of a process workflow involves automatic tracking and monitoring of tasks and enables continuous metrics collection (e.g. literature tracking tool, workflow management).

The Literature Tracking Tool from Covance is a comprehensive repository for literature abstracts and tracks the entire literature monitoring workflow. It provides real time dashboards and enables online review of the abstracts with links to the original full page article.

The Case Processing Assist tool (C-PAT) tool is a highly customizable Robotic Process Automation (RPA) tool for assisted case data entry into Argus, ARISg or any custom database. It automates case data entry for structured source documents and ensures improved quality and efficiency. It also serves as a platform to attain one touch case processing involving a single round of manual interaction from case intake through case submission.

Our Intake Processing Assist Tool (I-PAT) tool completes all in-take activities for case processing. This entails a three level duplicate search on two systems, parsing the information & automated data entry in to the database from the structured fields of the source documents. The information is collected from consumer call centers, social media and other consumer facing platforms and is used by our Global Case Management team.

The Medical Review Assist tool takes the automation process one level up to Cognitive Automation. It supports the medical reviewer or safety physician in reviewing safety source documents and other safety data. The tool applies natural language processing to help identify drug event pairs while leveraging existing medical terminology classifications such as Medical Dictionary for Regulatory Activities (medDRA) and World Health Organization Drug Dictionary (WHODD).

Artificial Intelligence consists of tools and systems that leverage artificial intelligence technologies like machine learning and deep learning to self-learn and self-train as they process a growing volume of safety data. Such AI tools coupled with RPA and cognitive computing hold the promise of end to end automation with minimal or no human intervention.

Operational Benefits

  • Significant cost savings via enhanced productivity with expected efficiency gains of up to 50%
  • Highly customizable and database agnostic
  • Improved quality through standardized inputs
  • 100% regulatory compliance and faster turnaround time (TAT)
  • Automated case intake and case processing

Strategic Benefits

  • Standardization and automation of PV processes and safety data management through integration of safety data by application of appropriate data and system interoperability standards, implementation of best practices and technological concepts including work flow management technology to ensure appropriate transparency and accessibility of safety information and targeted automation for enhanced PV.
  • Proactive PV and risk minimization to identify and predict emerging safety signals by implementation of data mining techniques to bolster safety analytics, reporting and investigation. Faster signal adjudication and reporting and management provides real-time safety summaries, promoting timely awareness of safety risks across the portfolio and timely execution of safety risk minimization activities.
  • Open and transparent data sharing with regulators, prescribers and patients will build public trust and confidence, encourage greater openness across the industry, and promote impartial comparisons of alternative products. This will drive more trust, collaboration and ultimately fewer ADRs