AI Integration in Real Time Pharmacovigilance Workflow

Real-Time Pharmacovigilance and Adverse Event Detection

1. Data Collection

1.1 Sources of Data

• Electronic Health Records (EHR)
• Social Media Monitoring
• Clinical Trial Reports
• Patient Registries

1.2 Tools for Data Collection

• IBM Watson Health
• Oracle Health Sciences
• Medidata Solutions

2. Data Processing and Integration

2.1 Data Cleaning and Normalization

Utilize AI algorithms to cleanse and standardize data from various sources to ensure accuracy and consistency.

2.2 Integration with Existing Systems

Implement APIs to integrate collected data into existing pharmacovigilance systems for seamless access and analysis.

3. Adverse Event Detection

3.1 AI-Driven Signal Detection

Employ machine learning models to analyze large datasets for identifying potential adverse events.

3.2 Tools for Signal Detection

• Google Cloud AI
• Amazon Comprehend Medical
• BioSymetrics Platform

4. Risk Assessment and Analysis

4.1 Automated Risk Scoring

Use AI algorithms to assign risk scores to detected adverse events based on severity and frequency.

4.2 Predictive Analytics

Implement predictive modeling to forecast potential future adverse events based on historical data.

5. Reporting and Regulatory Compliance

5.1 Automated Reporting Tools

Utilize AI-driven reporting tools to generate compliance reports for regulatory bodies.

5.2 Tools for Reporting

• VigiBase
• Oracle Argus Safety
• ArisGlobal

6. Continuous Monitoring and Feedback Loop

6.1 Real-Time Monitoring

Implement dashboards powered by AI to monitor adverse events in real time and provide alerts.

6.2 Feedback Mechanisms

Establish feedback loops to refine AI models based on new data and outcomes, enhancing detection capabilities.

7. Stakeholder Communication

7.1 Internal Communication

Facilitate communication among internal teams using collaboration tools to discuss findings and strategies.

7.2 External Communication

Develop protocols for communicating findings to healthcare professionals and regulatory agencies.