Customer Overview
The customer is a leading CRO running clinical trials in community oncology sites in the US. Focused on community-based Hematology & Oncology research sites, they provide real-world experience, data and outcomes for improved clinical utility of cancer therapies.
Challenges
The customer faced significant hurdles with outdated and manual systems that severely hampered the oversight and documentation of their clinical trials. These outdated systems made it difficult for them to manage multiple trial sites effectively, leading to a lack of cohesive communication and data sharing. The rigid and inflexible nature of their existing EDC provider compounded these problems, particularly when attempting to manage the complexities inherent in Hematology and Oncology research. In these research areas, the trials are highly specialized and require systems that can adapt to intricate protocols and rapidly evolving data requirements. However, the customer’s current technology stack was not only outdated but also disjointed, which led to frequent workflow disruptions and inefficiencies in trial management. These challenges were further exacerbated by ineffective budget management, which was hindered by the inability to track trial costs in real-time or allocate resources efficiently. Together, these issues contributed to delays, increased costs, and reduced overall productivity in their clinical trial processes.
Solution
To address these challenges, the customer turned to Cloudbyz, which implemented an integrated EDC solution as part of a broader eClinical suite. The Cloudbyz EDC system centralized clinical trial operations by providing a secure, cloud-based platform for storing, managing, and tracking critical trial data. The solution ensured real-time data capture through eCRFs, robust query management, and real-time notifications, improving the accuracy and timeliness of data collection. The EDC system allowed for seamless integration with the Investigator Portal, enabling site staff to enter and review data in real-time, and providing sponsors with immediate access to trial progress. Additionally, the system included automated CRF data exports for reporting, Source Data Verification (SDV), and Source Data Review functionalities, which significantly reduced the risk of errors and ensured compliance with regulatory standards. By unifying these processes, Cloudbyz's EDC solution modernized the customer’s trial management, improving data quality, and accelerating the decision-making process.
Benefits
The adoption of Cloudbyz’s EDC system brought substantial benefits to the customer’s clinical trial management processes. The platform’s real-time data capture and visibility features enabled quicker, more informed decision-making, allowing stakeholders to address issues promptly and prevent costly delays. By leveraging automation for query management, Source Data Review, and SDV, the customer experienced a significant reduction in manual data entry errors and operational inefficiencies. Cloudbyz’s eTMF system also streamlined document management, ensuring that all trial documentation was inspection-ready and fully compliant with regulatory standards, including FDA, GCP, and EU-GDPR. Furthermore, the platform’s centralized approach optimized resource allocation and reduced trial timelines, allowing the customer to adopt a more patient-centric process. By improving collaboration between investigators, sponsors, and CROs, the Cloudbyz EDC system facilitated smoother trial execution and better trial outcomes.