Using Artificial Intelligence in Pharmacovigilance

October 12, 2021

Using Artificial Intelligence in Pharmacovigilance

As we briefly discussed in the previous chapter, Artificial Intelligence (AI) is used to simulate the processes of a human brain with the help of computer systems. It encompasses various technologies, including rule-following, reasoning – using rules to reach rough or specific conclusions, learning, and self-correction.

Implementation areas of AI

In the area of pharmacovigilance electronic systems, AI technologies could be implemented in case collection, consolidated reporting, and signal and quality management.

For example, using machine learning algorithms to automate medical coding according to MedDRA dictionary for medical terms or WHODrug dictionary for medical products.

The image below demonstrates how AI based on a neural network is used to detect and manage signals, find duplicates, and auto-code in the Flex Databases Pharmacovigilance system.

Additionally, AI is used in safety signal detection, including:

  • multimodal signal detection,
  • signal detection using neural networks,
  • predictive signal detection.

In general, AI and other automation technologies in pharmacovigilance allow to eliminate human errors, standardize processes, shorten the processing cycle, and reduce manual work.

Examples of AI technologies 

TechnologyShort descriptionUse cases of pharmacovigilance electronic system 
Machine learning (ML)Machine learning (ML) is a subset of AI, allowing the creation of algorithms that can learn and make predictions based on the data. Instead of following a predefined set of rules and instructions, these algorithms are taught to identify patterns in big data and improve over time and with more data. This technology helps identify potential signals.Case collection, periodic reporting, signal management, and risk management.
Neural networkSystem replicating a neural structure of a mammal’s brain. Neural networks usually consist of multiple layers which are formed by numerous nodes. This technology helps identify potential signals.Case collection, periodic reporting, signal management, and risk management.
Semantic searchSemantic search is meant to improve search accuracy and deliver relevant results by understanding user intentions and search query context.Case collection, periodic reporting, signal management, and risk management.

AI use cases

Use case 1Automated case collection and evaluation of serious adverse events (SAE) from online comments on Indian websites. 

Traditional safety data collection is challenging in this area, however, using of artificial neural networks and sentiment analysis allows to automatically identify characterizations of the researched objects in the emotionally coloured text.

Use case 2. Predicting the safety profile of a developed drug

Researchers combined in vitro data with safety information from FAERS database, and created machine learning models, allowing to predict future adverse events based on the data point from other databases, such as PubMed.

Blog

March 10, 2025
Webinar: Digitalizing Clinical Trials – The Smarter Way to Run the Studies

📅 Date: 20 March, 2025  ⏰ Time: 16:00 CET 🔗 Register now with just two clicks Join SOLTI and Flex Databases to discover how SOLTI transformed trial management, overcame challenges, and unlocked the full potential of digitalization. Our expert panel includes:🔹 Marietta Sarkisian – Global Director, Business Development, Flex Databases🔹 Lídice Vidal – Chief Clinical […]

March 4, 2025
Alithia Choose Flex Databases as eTMF provider

Alithia Life Sciences is a full-service Contract Research Organization dedicated to deliver high-quality clinical trial management solutions. With a strong focus on efficiency, compliance, and operational excellence, Alithia partners with pharmaceutical and biotech companies to ensure the seamless execution of clinical trials. To further enhance its document management and trial oversight, the company selected Flex […]

February 27, 2025
Flex Databases 2025 Conference Calendar: Meet Us Around the Globe

Join Flex Databases at key industry conferences throughout 2025! Our team will be attending major clinical research and life sciences events worldwide, ready to connect, share insights, and discuss how our platform can streamline your clinical trial management. Check out our event schedule and book a meeting with us at contact@flexdatabases.com. See you there! Date […]

February 25, 2025
Clinical Research Glossary: Key Terms and Definitions

A Additive Effect – The combined effect when two or more things are used together. Adherence – Following the study directions and requirements. Adverse Event – A negative change or medical occurrence that happens during a clinical trial or within a certain time period after the trial has ended. An adverse event may or may […]

Contact us

Get in touch to discuss compliance, implementation, demos, pricing

We are here for all of your questions! Tell us more about yourself and we will organize a tailored live demo to show how you can power up your clinical trials processes with Flex Databases.