In the increasingly complex world of pharmacovigilance, the volume and variety of adverse event (AE) reports are growing at an unprecedented pace. For pharmaceutical companies, contract research organisations (CROs), and marketing authorisation holders (MAHs), the pressure to ensure compliance, accuracy, and timeliness in adverse event (AE) case processing has never been greater. Traditional manual approaches are proving insufficient to meet the evolving regulatory expectations and operational demands.
This article explores how automation is fundamentally reshaping the way adverse event cases are handled, with a focus on practical applications, regulatory benefits, and real-world success stories.
The Burden of Manual Case Processing
Manual AE case processing remains one of the most resource-intensive components of pharmacovigilance. Safety teams must gather data from multiple sources, including clinical trials, post-marketing surveillance, patient reports, and submissions from healthcare providers. Each case requires meticulous data entry, MedDRA coding, narrative creation, and regulatory documentation.
- Delays in data entry and narrative generation
- Inconsistent MedDRA term selection
- Higher risk of human error and compliance breaches
- Inefficiencies in case prioritisation and follow-up
Common challenges include:
These inefficiencies can have serious implications, from delayed regulatory submissions to increased audit findings and compromised patient safety.
Where Automation Makes a Difference
Automation technologies have transformed adverse event case processing from a reactive, manual task into a streamlined, intelligent workflow. Here are key areas where automation brings measurable improvements:
1. Automated Case Intake
Digital tools can extract relevant case data from various sources, such as emails, call centre transcripts, and electronic medical records, and automatically populate the necessary fields in Individual Case Safety Reports (ICSRs). Source
2. MedDRA Coding Support
With automated term selection algorithms, systems can identify the most appropriate MedDRA terms with high consistency, reducing coding errors and improving data quality. Source
3. Narrative Drafting
Narratives are a critical component of regulatory submissions. Automation can assist in drafting coherent, structured narratives based on case data, significantly reducing the time required for manual writing. Source
4. Duplicate Detection and Case Validation
Automated systems can flag potential duplicate reports, check for missing data, and validate fields in real time, ensuring compliance with ICH E2B(R3) guidelines. Source
5. Regulatory Document Preparation
Automated platforms can generate necessary documents, such as CIOMS forms and submission-ready ICSRs, tailored to meet the standards of agencies like the MHRA, EMA, and FDA. Source
Real-World Use Case: Improving Efficiency and Compliance
While exact audit score improvements are not always disclosed publicly, real-world implementations show consistent performance benefits from pharmacovigilance automation. For example:
- One biopharma company reported a 51% improvement in overall pharmacovigilance efficiency after introducing case automation tools, including intake, MedDRA coding, and narrative assistance. (Oracle Whitepaper)
- A Pfizer-led proof-of-concept study explored how artificial intelligence could support automated case intake and narrative drafting across multiple vendor tools. The study evaluated performance using precision, recall, and F1 scores—highlighting the potential of AI to assist in AE case processing workflows. (NCBI)
- Automation has enabled teams to reallocate safety experts to strategic roles, reducing repetitive workload and allowing more focus on signal detection and regulatory decision-making.
These examples reflect the growing industry shift toward intelligent automation to handle increasing caseloads, reduce errors, and enhance compliance.
Ensuring Regulatory Compliance
Pharmacovigilance systems must adhere to strict regulations, including:
- ICH E2B(R3) – governing electronic transmission of ICSRs. Source
- 21 CFR Part 11 – ensuring electronic records integrity. Source
- GDPR– protecting personal data. Source
Automated solutions are built to ensure compliance with these regulations. For example, audit trails are maintained for every data field update, access controls are strictly enforced, and systems are validated according to GxP standards.
Automation also improves readiness for inspections by creating a clear, traceable history of each case and enabling faster retrieval of records during audits.
Key Benefits of Automation in AE Case Processing
- Improved data quality and consistency
- Faster case turnaround times
- Enhanced compliance with global regulations
- Reduced operational costs
- Increased capacity without expanding headcount
These benefits contribute to safer pharmacovigilance operations, ultimately supporting public health while maintaining organisational efficiency.
FAQs: Drug Safety and Pharmacovigilance Automation
It refers to the collection, assessment coding, narrative writing, and regulatory submission of reports on adverse effects experienced by patients taking a pharmaceutical product.
Automation reduces manual workload, improves accuracy, accelerates submissions, and ensures compliance with global regulatory standards.
Yes, even smaller organisations can benefit from automation to manage caseloads efficiently and cost-effectively.
No. While automation handles repetitive tasks, expert human oversight is essential for complex assessments, causality analysis, and decision-making.
Systems should comply with ICH E2B(R3), GDPR, 21 CFR Part 11, and GxP validation requirements
Conclusion
In today’s regulatory environment, the ability to efficiently manage adverse event cases is crucial. Automation in case processing is not a futuristic concept—it is a practical necessity that is already delivering value to forward-thinking pharmaceutical and biotech companies.
By eliminating manual bottlenecks, improving accuracy, and ensuring audit readiness, automation enables organisations to scale their pharmacovigilance activities while maintaining the highest standards of patient safety.
“Interested in transforming your adverse event case processing? Speak to our team today and discover how automation can work for you”