A client scaling Pharmacovigilance Success across 200+ Pharma Giants with PvEdge

About Client

A leading pharmacovigilance service provider based in Istanbul, Turkey, offering comprehensive drug safety and regulatory services to pharmaceutical clients worldwide. With a strong portfolio of 200+ major clients across the globe, the organization is committed to ensuring patient safety and regulatory compliance through reliable pharmacovigilance solutions. 

The Challenges

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The client was operating with fragmented systems for case processing, leading to inefficiencies and a high dependency on manual efforts.
Regulatory submissions varied by region and authority, requiring data to be formatted differently for each client, making it complex and error-prone.
The lack of a centralized system made it challenging to scale operations or ensure consistent global compliance across clients.
Delays, compliance risks, and limited visibility into safety data created operational bottlenecks and audit concerns.

Tackling the Challenges

Conducted a comprehensive gap analysis of their existing systems, workflows, and regulatory processes.

Data integrity

Implemented PvEdge® in a multi-tenant model, customized for each client’s data and workflow needs.

Need for Advanced Automation

Enabled automated global submissions, case processing, and built-in compliance with leading regulatory frameworks.

Inadequate testing

Provided tailored onboarding, training, and system configuration for seamless transition and user adoption.

Efficient Case Management:

Delivered real-time monitoring and reporting tools to increase transparency and decision-making efficiency.

Why PvEdge®

The client chose PvEdge® for its end-to-end pharmacovigilance capabilities and strong alignment with global regulatory requirements. Key reasons for the selection included: 

  • Support for ICH E2B (R2/R3) formats and generation of CIOMS, MedWatch, and XML reports for global submissions.
  • AI-powered ICSR case processing for speed, accuracy, and reduced manual workload.
  • Regulatory and data compliance with GAMP5, GxP, GDPR, and HIPAA.
  • Client-controlled masters and system configuration with zero vendor dependency.
  • A scalable, multi-tenant architecture supporting secure, client-specific data segregation.

Business Impact

  • Improved Operational Efficiency
    Automated workflows drastically reduced manual tasks, accelerating case processing and boosting overall productivity.
  • Seamless Global Compliance
    PvEdge ensured adherence to global regulatory standards like ICH E2B (R2/R3), GAMP5, GDPR, and HIPAA—minimizing compliance risks.
  • Scalable Client Management
    With secure multi-tenant architecture, the system now supports 200+ global clients, allowing faster onboarding and smooth expansion.
  • Enhanced Data Quality & Reporting
    Custom filters and reconciliation tools improved reporting accuracy and provided better oversight across all safety operations.
  • Greater Audit Readiness & Decision Support
    Structured, real-time data access has strengthened audit preparedness and enabled faster, more confident decision-making.

About PvEdge®

PvEdge® is an advanced AI-enabled, cloud-ready pharmacovigilance software for safety database management. PvEdge® helps companies manage safety data and stay compliant with regulations. The platform makes tasks like data migration and reporting easier with its simple interface and useful analytics. By connecting different systems, PvEdge® allows organizations to work more efficiently and accurately. With a focus on improving productivity, it helps pharmaceutical companies overcome challenges and remain competitive. 
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