Intelligent Automation Opportunities in Pharmacovigilance Initiative is focused on identifying opportunities for utilizing different types of intelligent automation technologies to improve industry PV process quality, efficiency, and PV data insights, ultimately to improve PV work for patient safety. As of April 2025, this initiative is complete. No new solutions or updates are planned.
Individual Case Safety Report Process and Technology
TransCelerate’s Intelligent Automation Opportunities (IAO) in Pharmacovigilance initiative has been working to evaluate various pharmacovigilance processes to facilitate systematic innovation with intelligent automation. The individual case safety report (ICSR) process was the first process selected for evaluation because of its resource-intensive nature, risk of errors, and operational inefficiencies.
The initial work from the team articulated an end-to-end ICSR process that would generically apply to various pharmacovigilance organizations, despite organizational variations in specific ICSR process steps. This paper aims to address the need for a systematic review framework for automation of the ICSR process from the value, impact, perceived risk, and opportunity point of view.
The following solutions are:
Automation Opportunities in Pharmacovigilance: An Industry Survey
Maps the Individual Case Safety Report (ICSR) process and evaluates opportunities for intelligent automation within that process in terms of perceived risk, the effort required and expected benefit.
Download the article here.
Industry Perspective on Artificial Intelligence/Machine Learning in Pharmacovigilance
This published paper is a follow-up to the ICSR Paper which combines data from 2019-2021. The paper describes major trends, interprets and suggests why these trends exist, includes an updated ICSR Heat Map and includes an update for case studies from the Foundation Paper Table 2. Here is a video discussing the paper in detail.
Download the article here.
Technology Matrix
Provides technology survey benchmarking data for the 2020-2021 period, regarding the types of technologies available in pharmacovigilance with an aggregated view of the level of implementation of each technology with each Individual Case Safety Report (ICSR) process step, comparing the aggregated implementation levels across time periods.
Download the solution here.
Interactive ICSR & Automation Technologies Tool
The Interactive ICSR and Automation Technologies Tool (IATT) is an interactive process flow depicting each process step within the individual case safety report (ICSR) process.
Intelligent Automation Thought Leadership
TransCelerate’s Intelligent Automation Opportunities (IAO) in Pharmacovigilance initiative has been working to evaluate various pharmacovigilance processes to facilitate systematic innovation with intelligent automation.
The following solutions are:
Utilizing Advanced Technologies to Augment Pharmacovigilance Systems: Challenges and Opportunities
Facilitates understanding of intelligent automation technology-related terms in the PV context. Also, it includes a summary of current use cases.
View the article here.
Validating Intelligent Automation Systems in Pharmacovigilance: Insights from Good Manufacturing Practices
This position paper provides considerations to the industry on validation strategies that can be utilized for emerging AI-based automation technologies. It is intended to facilitate dialogue and collaboration with Health Authorities and industry on this topic. Here is a video discussing the paper in detail.
View the article here.
Black Swan Events and Intelligent Automation for Routine Safety Surveillance
This published paper discusses black swan events in the context of pharmacovigilance and the role of machine learning in helping to mitigate such events. The paper explores effective approaches to managing risk of potential black swan events and outlines several strategies to address those risks of potential black swan events during data ingestion. Here is a video discussing the paper in detail.
View the article here.
Artificial Intelligence (AI)-based Validation Case Study Themes
In 2021-2022, TransCelerate interviewed several Member Companies implementing Artificial Intelligence (AI)-based PV systems within a GxP environment. These early adopters needed to anticipate that internal audits and external inspections of AI-based systems would be performed before reliable regulatory guidance was available. The themes from these interviews provide concrete examples of how AI-based technologies can be implemented within the individual case safety report (ICSR) process. They are organized using key areas from TransCelerate’s Validation publication to enhance discussion and co-learning with Health Authorities and outline various considerations for validation.
Download the solution here.
Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products
In 2023, TransCelerate responded to the FDA call for public comments to facilitate a discussion with stakeholders on the use of artificial intelligence (AI) and machine learning (ML) in drug development to help inform the regulatory landscape in this area.
Download TransCelerate and other stakeholder comments here.
ICSR Replication
The basis of pharmacovigilance is provided by the exchange of Individual Case Safety Reports (ICSRs) between the recipient of the original report and other interested parties, which include Marketing Authorization Holders (MAHs) and Health Authorities (HAs). Different regulators have different reporting requirements for report transmission. This results in replication of each ICSR that will exist in multiple locations. Adding in the fact that each case will go through multiple versions, different recipients may receive different case versions at different times, potentially influencing patient safety decisions and potentially amplifying or obscuring safety signals inappropriately.
The following solutions are:
Individual Case Safety Report Replication: An Analysis of Case Reporting Transmission Networks
A peer-reviewed article that reports on an analysis performed to provide a first-time quantification of the amount of ICSR (Individual Case Safety Report) replication taking place within the pharmacovigilance ecosystem. The analysis utilizes aggregated ICSR transmission data from seven participating TransCelerate member companies, which accounts for 20% of the total ICSR case volume reported to the FDA.
View the article here.
Furthermore, you can view the webinar recording about TransCelerate’s Individual Case Study Report (ICSR) Replication Paper.
ICSR Replication Case Study
A case study of a single ICSR becoming over 200 ICSRs through replication. Includes how it happened, the impact on ecosystem stakeholders, actions taken to reconcile, and the result of reconciliation.
Signal Management
Signal Management – Intelligent Automation Opportunities for Signal Detection
This solution identifies how a representative sampling of major pharmaceutical companies are currently using intelligent automation for various PV process steps within a generic signal management framework and thereby raises awareness as to the potential opportunities for the broader industry in this area.
Download the solution here.
