The Challenge

• Outdated safety system slowed operations: The customer relied on a legacy EDC to manage safety reporting, causing delays and excessive manual effort.

• Lack of workflow automation: The system couldn’t automatically trigger tasks, assign responsibilities, or handle follow-ups efficiently.

• Siloed processes across divisions: C ritical business units operated independently, increasing complexity and impacting cross-functional coordination.

• Need for cloud-based integration: They required a centralized platform that could connect with existing systems and deliver real-time visibility into adverse event data, regulatory report generation, and workload distribution.

The Solution

• Integrated Safety Platform Across Divisions: Cloudbyz implemented its Safety & PV database to streamline the intake, review, and reporting of clinical safety events for TMTT, Surgical and other business units.

• Legacy System Interoperability: The solution was integrated with the customer’s existing EDC, enabling users to continue with their familiar data entry processes while improving back-end processing and automation.

• Automated Workflow Enablement: Cloudbyz automated safety task creation and assignment, configured rules for email triggers based on response conditions, and simplified case routing for quicker decision-making.

• Regulatory Reporting and XML Outputs: The system enabled generation of regulatory reports and standardized XML outputs instantly, supporting global device reporting needs with minimal manual intervention.

• Role-Based Dashboards and Insights: With real-time dashboards, safety managers across divisions could access high-impact analytics, identify bottlenecks, and make proactive decisions on safety events.

The Results

• Centralized safety operations: All divisions now operate on a unified cloud platform, increasing visibility and efficiency.

• Regulatory agility: Reports that once required days to compile are now generated in a single click, ensuring timely submissions and better compliance.

• Improved collaboration: By automating task assignments and communications, the solution fostered collaboration across regulatory, safety, and clinical teams.

• Enhanced decision-making: Interactive dashboards provide instant insights into case volumes, task status, and workflow efficiency, enabling leadership to take data-driven actions quickly.