Background

In 2024, a Biotech company was conducting two oncology trials, built on a well-established Electronic Data Capture (EDC) system provided by one of the top global EDC vendors. The sponsor faced several challenges related to cost, user satisfaction, and quality of data capture with the existing system.

It led them to make the difficult decision to change EDC system during study execution, despite the risks related to such an activity.

High costs

The existing EDC system incurred significant costs for both licensing and ongoing support, straining the study budget.

User dissatisfaction

The user interface of the existing EDC system was not intuitive, making it difficult for the clinical sites and the data management team to navigate it, leading to frustration.

Tumor evaluation

The system had limitations in evaluating lesions at different points in time. In both trials, the target lesion varied between visits, but the existing EDC could not handle the variability. This resulted in cumbersome workarounds and potential data quality issues.

Solution: Migration to cubeCDMS

The study team decided to migrate the study to cubeCDMS, as it offered several advantages in cost and functionality that made it a more viable option. They were anxious about the migration process, which can lead to quality issues. Our data management and operations team used the following steps to manage it:

Planning and assessment

Out team led a thorough assessment of the existing study requirements, structure and data.

Customization and setup

cubeCDMS was customized by to mirror the existing study design while leveraging the system’s functionalities to improve data capture and user experience.

Data migration

All historical data from the original EDC system were securely and accurately migrated to cubeCDMS.

User training

Comprehensive training sessions were provided to ensure a smooth transition and to familiarize users with the new system.

Results

Cost reduction

cubeCDMS provided a more cost-effective licensing model, estimated to be 50-60% lower than the original EDC vendor. The intuitive design of cubeCDMS also reduced the need for extensive support, resulting in lower operational costs.

User satisfaction

cubeCDMS featured a user-friendly interface that was easy to navigate, significantly improving the user experience. The system's flexibility allowed for customization according to user preferences, leading to higher satisfaction rates among study teams.

Tumor evaluation

Unlike the previous EDC system, cubeCDMS allowed for independent evaluation of lesions at each point in time. It made it easier for the sites to capture the right data, leading to a reduction in queries, which had a positive impact on the sites and the data management team’s workload.