Pharmacovigilance (also known as PV, or PhV) is the process by which companies monitor various channels in order to identify and act upon potential issues with their products in the market, such as side effects of drugs or faults in medical devices. As these issues can have serious implications with the health of individuals, crucial components of Pharmacovigilance are speed and accuracy.
Compliance requirements from the FDA (Food and Drug Administration) in the USA, and the EMA (European Medicines Agency) in the EU are strict and require quick reporting turnaround times. Adverse event reporting is traditionally a highly manual, resource intensive process that is decentralized across multiple local sites around the world, that carry out the intake and interpretation of adverse event reports in their individual location. Adding robotic process automation to the Case Intake workflow is crucial when it comes to saving critical time as well as creating substantial cost savings.
Case volumes growing exponentially
Effort and cost intensive
Highly manual process
Traditional methods are slow
Regulatory filing deadlines (fines)
Delays to market equates to lost revenue
The process of recording adverse events involves accepting adverse event reports from various sources from around the world. These reports need to be triaged and categorized according to the product, the side effects and other pieces of information, such as dosage, in order to generate a case and, where relevant, make a regulatory submission. Automation can play a crucial role in reducing the time it takes to file a report. Starting with the initial file intake and preparation step, we can make use of file handlers and optical character recognition to get text into machine-readable format. Then, of course, high-quality adapted Neural MT can be deployed to homogenize reports into English for rapid processing. After that, various AI, machine learning and NLP methods can be used to automate document classification, detect specific entities, extract information for case generation and summarization.
Iconic’s cutting edge technology solution for Pharmacovigilance enables the rapid processing of large volumes of foreign language adverse event reports, which is essential to limiting the risk of missing strict regulatory filing deadlines and subsequent fines. Our automation process, integrated throughout the Case Intake workflow, centralises the workflow, allowing for input harmonization and increased efficiencies, and processes files in a single language. This process reduces outsourcing costs and internal overheads related to vendor engagement.
Iconic’s proprietary Neural MT Translation and Automation solutions are created in-house by our own team of expert scientists. We work with you to build a bespoke solution tailored to your specific needs. Our domain-adapted solutions afford the highest level of translation quality. All the while, you can rest assured that your data is treated with the upmost security, with top-tier secure cloud computing.
In this video Iconic’s Global Head of Enterprise Sales, Diane O’Reilly, shares some specific examples of natural language processing innovation by the life sciences industry.