Introduction
Pharmacovigilance is at the heart of patient safety and regulatory compliance. But manual processes, siloed systems, and increasing case volumes make adverse event reporting complex and time-consuming.
The solution? AI-driven automation.
Companies like Cloudbyz are leveraging machine learning, natural language processing, and automated workflows to revolutionize case processing.
Why Pharmacovigilance Needs Automation
- Rising Case Volume – Increasing clinical trials and real-world drug use mean more adverse event cases to manage.
- Regulatory Pressure – Agencies like FDA, EMA, and MHRA require fast, accurate submissions.
- Manual Errors and Delays – Traditional methods introduce risk, inefficiency, and compliance gaps.
How Cloudbyz Transforms the Pharmacovigilance Workflow
- Automated Case Intake – Captures adverse events from spontaneous reports, literature, call centers, and clinical trials.
- Medical Coding with AI – Uses MedDRA, IMDRF, and HRUG for standardized reporting.
- Regulatory-Ready Submissions – Supports E2B (R2, R3), MedWatch, CIOMS, and Excel exports.
- Workflow Automation – Real-time notifications ensure serious cases are flagged and reviewed faster.
- Seamless Integrations – Connects with EDC, investigator portals, and sponsor platforms.
The Impact: Faster, Smarter, More Compliant Pharmacovigilance
With automation, teams can reduce case processing time, enhance compliance, and improve patient safety.
Watch the full Cloudbyz demo here:
