Customer Overview
The customer is a leading multinational pharmaceutical company based in India and overseas, and is committed to providing affordable and innovative medicine for healthier lives. The customer approached Cloudbyz to provide a solution to scale its clinical trials operations.
Challenges
The customer faced significant challenges in managing clinical trials due to reliance on manual, paper-based processes and disconnected legacy point solutions. This outdated approach resulted in operational inefficiencies, poor collaboration between internal teams and external stakeholders, and a delayed time to market for trial outcomes. The lack of integration between systems made it difficult to have a real-time view of trial data, which increased the risk of errors, reduced data accuracy, and prolonged decision-making. As the number of trials grew, these inefficiencies compounded, driving up operational costs and stretching resources. The existing setup was not only unproductive but also unsustainable, prompting the need for a more integrated, automated, and efficient approach to clinical trial management. Addressing these shortcomings became critical to improving the speed and accuracy of trial processes while reducing costs and enhancing collaboration across teams.
Solution
Cloudbyz provided an integrated eClinical solution designed to address these challenges by supporting end-to-end global clinical trials. The platform enabled seamless collaboration among internal and external stakeholders through dedicated portals, allowing for streamlined communication and efficient data sharing. At the core of the solution, Cloudbyz offered configurable eCRF forms that allowed for real-time patient data capture and analysis, significantly improving trial accuracy and speed. Additionally, Cloudbyz’s system included EDC functionalities such as Query Management and Real-Time Notifications, Source Data Review and Verification, Medical Coding using MedDRA and WHODD, and comprehensive document management via Cloudbyz eTMF. Investigator and CRO Portals were also deployed, facilitating efficient data entry and review processes. Together, these features provided a centralized and automated approach to trial management, ensuring data integrity, reducing delays, and supporting real-time decision-making.
Benefits
The implementation of Cloudbyz EDC allowed the customer to comprehensively manage the entire clinical trial process with real-time data visibility and advanced analytics, ensuring that all stakeholders could make informed decisions quickly. The platform's user-friendly interface supported rapid study builds, enabling efficient data collection and management while reducing the need for manual intervention. Cloudbyz’s EDC system ensured that all trial documents were inspection-ready and fully compliant with FDA, GCP, and EU-GDPR regulations, facilitating seamless collaboration across global teams. The centralized system provided enhanced data accuracy and compliance while also optimizing resources, leading to a reduction in operational costs. Whether dealing with clinical data of varying complexity and size, Cloudbyz EDC empowered stakeholders with the tools necessary for efficient, compliant, and streamlined trial execution, improving both operational speed and trial outcomes.