Need for this
MedDRA provides standardized, global medical terminology for coding and reporting adverse events, facilitating consistent data collection, analysis, and regulatory compliance for pharmaceutical products. It ensures harmonized communication across regulatory authorities, organizations, and stakeholders
How it Benefits
Simplifies data analysis by using a unified terminology structure.
Reduces manual errors and discrepancies in safety data.
Ensures global regulatory compliance with evolving safety standards.
Facilitates seamless communication between global health authorities and pharmaceutical companies.
How We Are Using This in Existing Products
PvEdge® integrates MedDRA Auto-Update to automate the process of updating medical terminologies, ensuring continuous alignment with the latest MedDRA versions. This feature eliminates the need for manual intervention, allowing for accurate adverse event coding and real-time updates. With automated mapping and regular updates, PvEdge® enhances efficiency while maintaining compliance with global regulatory frameworks.
Result of Implementation of MedDRA
Time Savings
Automates MedDRA updates, reducing manual work and speeding up processes.
Higher Productivity
Frees teams to focus on safety analysis instead of manual coding.
Better Accuracy
Ensures precise adverse event coding with automated mapping.
Scalability
Easily handles growing data volumes and evolving MedDRA versions.