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Simplifying Your Approach to Adverse Event Intake and Processing
IQVIA's Vigilance Platform simplifies case intake and case processing
Scott Fonseca, Global Head of Sales for Safety, Regulatory, and Quality Technology Solutions
Jan 12, 2023

Receiving Safety reports is a complicated process for many life-science organizations as data volume and complexity continue to increase with information flowing in from multiple global sources. Add in the changing regulations from local and regional agencies and it can become a compliance nightmare for companies. Revising case intake into an optimized, unified process can address these challenges. Technologies such as artificial intelligence (AI) and data automation can simplify the case intake process, while also ensuring quality is improved throughout.

Accessing the right information quickly in drug safety is of critical importance at all stages of drug development. Over half of all safety process activity is manual collation and extraction of data from one format to another – causing higher costs and lower quality. With increasing data volumes and complexity, traditional manual models of identifying AEs, understanding context, and review/case processing are no longer sufficient.

New solutions allow for the automation of the receipt and management of each AE collected providing an accelerated and streamlined intake process and enhanced data consistency. At the recent Safety Seminar in Boston, IQVIA executives delved deeper into IQVIA’s Vigilance platform to examine how integrated tech-enabled services allow life-science organizations to do upfront case processing for improving efficiency, quality and quickly raise queries to enable rapid insights needed for better decision-making.

Multiple technologies and life-science specific developments work together within IQVIA’s Vigilance Platform to simplify case intake and case processing:

  • Conversational AI
    Multi-channel, text and/or voice based conversational agents available on company or brand assets are utilized to offer support around the clock, 24/7/365, and can both identify and report AE or PQCs. In cases of escalation, full integration with contact center operations ensures a smooth hand-off. Voice based AE detection also reduces the cumbersome process of manually listening to AEs for quality checking and data extraction.
  • AI Search Engine
    An AI search engine can identify potential AEs, PQCs and other risks. It can detect across large and diverse datasets that might otherwise go undetected or fall to humans for review. It is an amalgamation of AE signal detection, entity extraction, and NLP analysis and uses AI and proprietary safety specific patterns (in multiple languages) to increase speed and quality while reducing compliance risk.
  • Guided Web-Form
    Multilingual guided web forms allow patients, HCPs, and PSPs to report AEs and reduce the downstream Safety team burden by eliminating data processing and conducting data verification checks, improving efficiency, quality, and safety. This technology reduces the need for Follow-ups and ensures data is received compliant with local privacy regulations in the countries in which it used.
  • Intake Management Tool
    AI, NLP and automated translation simplifies and streamlines receipt and management of AEs from many sources, such as forms, emails, E2B, and literature. These tools transform how key activities such as data validation, triage, duplicate checking, and redaction are performed – improving efficiency, and quality while significantly reducing cost of data entry at case receipt and down-stream.
  • NLP Technology
    Natural Language Processing is an AI-based technology that enables effective handling of large volumes of unstructured text. In safety case intake, NLP ensures robust identification of relevant AEs and improving coding consistency in a reliable and repeatable process that decreases manual workload. NLP provides rapid access to landscape of safety data from literature, drug labels, regulatory reviews, and other textual sources. With the ability to instantly identify related AEs NLP offers the opportunity for real-time alerting of critical AEs further increasing the value of AI to users.

Organizations have seen impressive results with these tools. For instance, a Tier 1 pharmaceutical firm processing 450K+ cases across the US, EU and Japan saw improved first-time quality by 20%, and a decrease in cost of data entry and QA by 35%-65% depending on case source. This organization also saw follow-up queries reduced by 30% using IQVIA’s Vigilance Platform.

IQVIA Vigilance modules Detect, Collect and Intake which utilize conversational AI, AI search engines, guided web-forms, intake management tools, and NLP technology, work together to enable organizations to streamline and improve AE and PQC intake to drive cost reductions, time savings and an increase in quality of the AE and PQC intake process.

To learn more about the IQVIA Vigilance Platform, please click here.

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