Our Service
How our service is composed
Elements from p.AI
Pharmacovigilance
High compliance and safety requirements, with increasing amount of regulations and adverse reaction report amounts.
Automated Pharmacovigilance
p.AI leverages Artificial intelligence to screen and process adverse reaction reports (Eudravigilance L2A ICSRs) automatically through our L2AI software.
Artificial Intelligence
Continuously learning algorithm, fully scalable, audited by competitor and a former BfArM lead auditor.
Our Service
L2AI – Level 2A Eudravigilance ICSR Screening
Adverse Reaction Screening
Automatic categorization and tagging of all ICSRs based on criteria such as: concerns customer portfolio, seriousness, SMQ (e.g. pregnancy related)
Data Import
Automatic download and import of required data such as customer portfolio overview and European wide product registrations into the L2AI system.
Database Import
Import of concerning ICSRs into the customer database, partner exchange, data reconciliation, partner reconciliation, documentation and reporting of whole process to customer.
Modification of ICSRs
Automatic modification of cases such as: follow-up and duplicate management, id tracking, case nullification.
Our Service
Literature Review
AI-Supported Screening
Automated processing and categorization of literature references to identify publications concerning the customer portfolio, supported by advanced AI models trained for pharmacovigilance.
Adverse Reaction Assessment
Comparison of reported reactions against existing knowledge bases such as SPCs and reference safety information, highlighting new or unexpected findings.
Human-in-the-Loop Validation
Expert review of AI-screened literature to ensure accuracy, contextual understanding, and compliance with pharmacovigilance requirements.
User Support
Structured presentation and tagging of literature to support efficient analysis, decision-making, and documentation for regulatory compliance.
Our Service
Package Material Comparison
Packaging Verification
Automated comparison of packaging material against SPC information and regulatory specifications to ensure consistency and compliance.
Blue Box Compliance
Integration of country-specific Blue Box requirements across European markets, with systematic checks for completeness and correctness.
Deviation Detection
Identification of discrepancies, missing information, or formatting errors in packaging material that may lead to regulatory findings.
AI & Expert Oversight
AI-driven analysis combined with human-in-the-loop validation to deliver accurate, reliable results tailored to customer needs.
Our Service
AICSR Database
Core Platform
Foundation for pharmacovigilance process automation with structured, regulatory-compliant data management.
API Integration
Standardized interfaces for seamless exchange with customer systems, partners, and regulatory authorities.
Duplicate Detection
Built-in logic for case matching and prevention of redundant entries to ensure data integrity.
Automation Ready
Designed as the backbone for advanced AI-driven modules, ensuring scalability and efficiency in pharmacovigilance operations.
Why you chose p.AI
Advantages
Improve Quality
With an audited, continuously learning algorithm with built-in error prevention.
High Compliance
Audited by competitor and former BfArM lead auditor & no false negatives in validation-set
Continuously Learning
Underlaying algorithm improves over time, further improving quality.
Scalable
Capable of managing high loads of ICSRs.
Reduce Costs
With a scalable software, working independently of the amount of adverse reactions and by freeing up employee capacities.
Cut Costs
L2AI can drastically cut cost up to 50% by automating the L2A case processing.
Reduce Errors
L2AI has a built-in error prevention, resulting in less errors and higher data quality.
Minimize Workload
After connecting to the customer database interfaces L2AI can work fully autonomously.