Case Study: Global Medical Devices company streamlines safety operations across multiple divisions with Cloudbyz Safety solution

Customer Overview

Our customer, a global leader in patient-focused medical innovations for structural heart disease, is dedicated to providing solutions for people battling cardiovascular disease. By partnering with physicians, they create products designed to help patients live longer, healthier lives.

Challenges

As the customer expanded, they faced significant hurdles with their legacy system for managing clinical safety data. The system, used to capture, process, and report safety data, was no longer meeting their growing needs. The safety reporting process was manual and time-consuming, leading to delays in reporting and reduced efficiency.

The complexity of the system required considerable effort for generating safety reports, which slowed down both decision-making and regulatory submissions. Additionally, limited cross-functional collaboration and the risk of manual errors in reporting made it difficult to ensure accuracy.

The customer needed a solution that would:

• Streamline workflows
• Ensure precise reporting
• Enhance cross-functional collaboration
• Seamlessly integrate with their existing EDC system
• Minimize manual tasks and optimize overall processes

Solution

To overcome these challenges, the customer implemented the Cloudbyz Safety & Pharmacovigilance (PV) database, fully integrating it with their existing EDC system. This integration allowed the customer to efficiently capture, process, and report clinical safety data across two business units while maintaining their existing data entry workflows.

By automating the safety reporting process, Cloudbyz reduced the need for manual interventions and preserved familiar workflows. Moreover, the platform provided comprehensive reports and dashboards, offering actionable insights that made complex regulatory reports easier to generate. With real-time data and intuitive dashboards, the team was able to respond more quickly to regulatory requirements and internal decision-making needs.

Benefits

The implementation of the Cloudbyz Safety database delivered several key benefits to the customer, including:

• A 25% increase in the consistency of adverse event data within just four months, leading to more reliable and actionable safety data.
• A 35% reduction in the time required to resolve safety reports, allowing the customer to manage risks more proactively and effectively.
• A 30% reduction in time spent submitting expedited adverse event (AE) reports, ensuring compliance with the 15-day regulatory submission window during a recent global surgical valve trial.

With Cloudbyz, users could now store, process, and report on clinical safety data within a single cloud platform, ensuring all data was centralized and easily accessible. This unified platform reduced inefficiencies and minimized the risk of data loss or errors.

The automation of tasks such as report generation and email notifications significantly improved both accuracy and efficiency. Regulatory reports that used to take days to prepare manually were now generated with a single click, cutting turnaround times and allowing the customer to respond faster to regulatory bodies.

Additionally, the real-time dashboards gave users high-level visibility into safety data, enabling informed decision-making. With access to detailed and up-to-date information, managers could easily identify safety trends, mitigate risks, and ensure that their safety processes met regulatory standards with minimal effort.

This combination of automation, real-time reporting, and actionable data analytics empowered the customer to achieve greater efficiency, accuracy, and compliance in their safety reporting processes.