7 use cases for VR exploration of regulated life sciences data

    Virtual and augmented reality technology continue to develop and improve at a rapid pace. Here’s how it can be useful for life sciences.

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    In the next waves of data transformation in life sciences, Regulatory and Quality teams will explore and interact with regulated product information and market intelligence using virtual or augmented reality (VR/AR).

    The ability to represent different data objects or assets in 3D models will pave the way for different data fields - country, drug type, dossier and document – to be represented and viewed in different combinations, by their different inter-dependencies.

    This presents a number of opportunities:

    1. In Pharmacovigilance and Safety, for signal detection.

    In the case of COVID-19 vaccines, Phase III clinical trials are being conducted with people out in the real world, making mass monitoring for potential adverse effects paramount. With 5 billion people targeted, each potentially generating 1MB of data, this task would overwhelm not just scientific brain capacity, but the current scope of AI. So those responsible need to be able to represent and configure the data in different ways to spot and compare potential adverse effects.

    2. Impact assessment, forecasting and simulation.

    As regulatory requirements evolve, VR or augmented reality visualization offers a chance to visually explore their impact right through a company’s operations and current assets. The addition of a third dimension would allow teams to factor in the current availability of resources and of network infrastructure as part of the calculations, weigh up all of the correlations simultaneously, and hone planning.

    3. Quality consistency checks across multiple data types and formats.

    Today, data sources take multiple different forms, from structured data and numerical values to free-form text, video and audio files. Introducing the VR/AR element could help ensure consistency across all the data and metadata, highlighting anything that needs to be corrected, completed or removed due to duplication.

    4. Including emotion in PV reporting.

    If headaches are emerging as a common adverse event, whether linked to a COVID treatment or some other medical intervention, the ability to include the dimension of emotion in analyses could help determine whether stress and anxiety might be significant contributors.

    5. Clinical trials planning and management.

    Adding a VR capability to clinical study planning and management, including dimensions for patient recruitment and availability, could make it easier to factor in all the variables and make more realistic calculations.

    6. Manufacturing & distribution impact assessments, forecasts and simulations, to aid planning.

    Getting the BioNTech-Pfizer COVID-19 vaccine to market requires a complex logistics chain and infrastructure, because of its temperature requirements. Navigating the considerations visually across multi-dimensional data sets would enable meticulous planning including any contingencies. Roads and trucks could represent supply and demand, and colors signal time or quality issues. In the context of COVID, a model of the earth and spike lengths could signal where peaks of the virus are currently or where demand is building/least fulfilled.

    7. Planning and managing marketing authorization and variation submissions.

    Visualizing eCTD submissions as 3D pyramids would make it easier to chart and influence progress - highlight anything incomplete or missing documents or data, and which submissions have deadlines approaching, aided by color coding.
    Before long, more intuitive 3D data modelling and visualization will become the norm, especially as VR headsets give way to wire-free glasses and eventually contact lenses, and as intense data processing is able to take place in the cloud.
    The prospect of being able to engage with information more intently and naturally, and to simultaneously include others in new data explorations, is what’s really exciting about all of this.

    Published on    Last updated on 19/05/2021

    #Regulatory Information Management (RIM), #Life Sciences, #Augmented Reality

    About the author

    Romuald has devoted his 25-year career to-date to various roles related to compliance, document management, and content management in the Life Sciences industry. He has held leadership roles both on the client side and in consulting, including delivery, sales, and project and line manager. His experiences bridge on-premise and cloud environments in Europe and the US. Romuald holds a Master’s Degree in Drug Regulatory Affairs from the University of Bonn, Germany, and a diploma in data technology from the Technical University Darmstadt, Germany.

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