From Manual to Mastery: How a Global certified CRO Transformed PV Case Processing with PvEdge®

About Client

A global pharmacovigilance services provider, trusted by Marketing Authorization Holders (MAHs) across multiple geographies. The organization specializes in end-to-end drug and device safety operations, with a strong emphasis on data integrity, operational excellence, and global compliance.

Previously dependent on external tools for case processing, the client faced operational bottlenecks, limited automation, and challenges in maintaining consistency and compliance across projects. To improve service quality and scale efficiently, they sought a unified, in-house solution.

Hassel

Dependency on External Tools

Using third-party platforms made it difficult to maintain case processing timelines, reduce errors, and meet the dynamic needs of MAH clients.

Manual Case Tracking & Limited Automation

Tracking case status manually introduced delays and compliance risks, with limited support for proactive quality control or scalability.

Compliance Vulnerabilities

Lack of built-in regulatory frameworks increased the burden of ensuring GAMP5, GxP, and GDPR compliance.

Inflexible Configuration Management

Any updates to product dictionaries, MedDRA versions, or workflows required vendor support, causing avoidable delays and system downtime.

Tackling the Challenges

Deployment of PvEdge® for Drug & Device Case Processing

The client implemented PvEdge^® to gain full control of pharmacovigilance workflows—enabling rapid processing, regulatory alignment, and operational agility.

Seamless In-House Case Management

Internal teams now manage all PV cases end-to-end without external reliance, enabling faster turnaround and uniform service quality across MAH clients.

Global Submission Readiness

PvEdge^® supports ICH E2B (R2/R3) compliance and auto-generates CIOMS and MedWatch formats for quick, accurate submission to global regulatory bodies.

Client-Controlled Configuration

Users can update product masters, MedDRA versions, and workflow settings instantly—without vendor involvement or downtime.

Integrated Validation Rules

Smart validation checks flag incomplete or non-compliant entries (e.g., missing documents or incorrect XML fields) before submission, reducing rejections.

Multi-Tenant Architecture

PvEdge^®’s secure, scalable design ensures isolated environments for each client, allowing clean data segregation and effortless growth.

Advanced Filtering & Reporting Tools

The system offers configurable filters and reconciliation options to generate submission-ready reports efficiently and accurately.

Automation-Driven Efficiency

Automated fetching of E2B fields, causality logic application, acknowledgment dispatch, and follow-up handling cut down manual work drastically.

Transformation Business Impact

50% Faster Case Turnaround: Automation and streamlined workflows cut case processing time in half, boosting MAH response speed.
30% Reduction in Data Errors: Integrated validation and auto-mapping improved data accuracy, minimizing regulatory submission rework.
100% System Uptime: Real-time, client-controlled configuration updates ensured zero downtime during operations.
Improved Audit Readiness: End-to-end compliance with GAMP5, GxP, GDPR, and HIPAA maintained continuous inspection readiness.
Stronger MAH Partnerships: Reliable, on-time delivery enhanced client trust and improved service-level consistency across regions.

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.