About Client
A trusted consulting partner to the pharmaceutical and biopharmaceutical industry, offering nuanced Regulatory Affairs expertise from a multifaceted perspective. With deep cross-functional knowledge across strategy, submissions, and lifecycle management, the organisation helps Marketing Authorisation Holders (MAHs) navigate complex global regulations while maintaining high standards of compliance and operational efficiency.
Hassel
The client relied on manual and semi-automated pharmacovigilance processes to handle Individual Case Safety Reports (ICSRs) for their MAH clients. This created operational inefficiencies and compliance risks, including:
Time-intensive workflows
with heavy reliance on manual data entry and reconciliation.
Regulatory risk exposure
due to potential delays or missed updates in safety case submissions.
Limited scalability
restricting their ability to onboard new clients or manage larger case volumes.
Vendor dependency and downtime
making updates and configuration changes cumbersome.
With rising case volumes and increasing regulatory scrutiny, the client required a robust, fully automated, and scalable solution to streamline operations and ensure compliance.
Tackling the Challenges
The implementation of PvEdge transformed their pharmacovigilance operations through:
AI-Powered ICSR Case Processing
Automating data entry, validation, and case review, drastically reducing manual intervention.
Streamlined Regulatory Submissions
Automated generation of ICH E2B (R2/R3) XML, CIOMS, and MedWatch reports, ensuring timely and accurate submissions across regions.
Client-Controlled Masters
Real-time configuration of product masters, MedDRA dictionary, and labelling, eliminating vendor dependency.
Multi-Tenant Scalability
Enabling secure data segregation and expansion for multiple global clients.
Compliance-Centric Architecture
Adhering to GAMP5, GxP, GDPR, and HIPAA standards for data integrity and audit readiness.
Custom Filters, Reconciliation & Reporting
Offering enhanced dashboards and tailored insights for complete process visibility.
Transformation Business Impact
Within the first six months of using PvEdge, the client experienced measurable improvements:
- Case Processing Time reduced by 45%, accelerating turnaround and submission timelines.
- Manual Effort decreased by 50%, enabling resources to focus on complex case review and quality checks.
- Regulatory Compliance improved to 100%, ensuring audit-readiness and smooth regulatory inspections.
- Scalability increased by 2.5x, supporting additional global clients without further infrastructure investment.
- Overall Operational Efficiency improved by 40%, driving cost savings and enhancing service delivery for MAHs.
About PvEdge® - A Trusted Pharmacovigilance Software
PvEdge® is an advanced AI-enabled, cloud-ready and trusted 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.