Smart Triage
Automating ICSR Processing for Pharmacovigilance Efficiency
Reconciliation involves comparing the safety data submitted by the company with the data stored in the regulatory agency's database to ensure consistency and accuracy. While this process is essential for maintaining compliance and patient safety, it comes with its own set of challenges.
About Smart Triage
SmartTriage is a unique pharmacovigilance tool designed to streamline and automate the processing of Individual Case Safety Reports (ICSRs) downloaded from the EMA EVWEB (EudraVigilance) platform. By implementing a sophisticated matching algorithm and providing an intuitive user interface, SmartTriage enhances the efficiency of reconciliation processes, allowing pharmaceutical companies to make informed decisions promptly
Key Features
Algorithmic Matching
Smart Triage incorporates a generic matching algorithm that intelligently compares downloaded ICSRs from EVWEB with the safety system of the pharmaceutical company.
The algorithm identifies matching and non-matching cases, taking into account various data points such as patient information, adverse events, and timelines.
Intuitive User Interface
The tool boasts a user-friendly and intuitive interface designed to enhance user experience.
Matching and non-matching cases are clearly presented, with relevant details displayed for easy comprehension.
Reason Attribution
For each pair of matching or non-matching cases, Smart Triage provides clear reasons for the decision, offering transparency and aiding users in understanding the algorithm's logic.
Informed Decision-Making
Users are empowered to make informed decisions based on the algorithmic suggestions. They can review the reasoning behind each match or non-match and take appropriate actions accordingly.
Browsable Case Repository
Smart Triage allows users to seamlessly browse through all the cases within the downloaded zip file from EVWEB.
The interface provides filters and sorting options for users to efficiently navigate and review individual cases.
Customizable Workflow Integration
The tool is designed to seamlessly integrate with existing pharmacovigilance workflows.
Users can customize the workflow to align with internal processes, ensuring a smooth transition from case assessment to resolution.
Workflow
Upload and Extraction
Users upload the downloaded zip file containing ICSRs from EVWEB to SmartTriage.
The tool automatically extracts and organizes the cases for further analysis.
Smart Triage employs its matching algorithm to compare each ICSR with the corresponding entry in the company's safety system.
Matching and non-matching cases are flagged with detailed explanations.
Algorithmic Comparison
User Review and Decision-Making
Users access the intuitive UI to review matching and non-matching cases, understanding the reasons provided by the algorithm.
Informed decisions are made based on the presented information, allowing for swift action.
Based on user decisions, Smart Triage facilitates the initiation of next steps, such as updating internal records, conducting further investigations, or taking corrective actions.
Next Steps and Resolution
Benefits
Efficiency and Time Savings
Smart Triage automates the time-consuming process of manual ICSR reconciliation, significantly reducing the workload for pharmacovigilance teams.
Enhanced User Experience
The user-friendly interface and intuitive design contribute to an enhanced user experience, making the reconciliation process more accessible and efficient.
Transparency and Accountability
The tool provides clear explanations for matching and non-matching cases, ensuring transparency in the decision-making process and supporting accountability.
Customization and Integration
Smart Triage's flexibility allows for customization to align with specific company workflows, ensuring seamless integration into existing pharmacovigilance processes.
In conclusion, Smart Triage stands as a powerful tool in the realm of pharmacovigilance, leveraging advanced algorithms and an intuitive user interface to automate and streamline the processing of ICSRs downloaded from the EMA EVWEB. By facilitating informed decision-making and providing transparency in the reconciliation process, Smart Triage empowers pharmaceutical companies to maintain data accuracy and compliance efficiently.