精选案例研究
Background
A European Contract Research Organization (CRO) sought to improve the efficiency and cost-effectiveness of their clinical trials. Faced with rising complexity in managing both Electronic Data Capture (EDC) and Randomization and Trial Supply Management (RTSM) systems, the CRO explored options for an integrated solution.
They initiated a vendor selection process, aiming to address the following challenges:
Lengthy study setup timesSetting up multiple, disparate systems for EDC and RTSM delayed study start-up times and required integrating between vendors. |
User experience fragmentationSite users and data managers had to navigate separate platforms for EDC and RTSM tasks, creating inefficiencies and errors. |
High eClinical study costsWorking with different EDC and RTSM vendors increased study budgets and required extra resources to manage reconciliation between systems. |
To address these challenges, the CRO implemented CRScube’s cubeCDMS and cubeIWRS as an integrated solution for both EDC and RTSM operations.
Solution: cubeCDMS & cubeIWRS
The client chose CRScube’s combined EDC and RTSM solution, as it aligned with their company objectives. They could see how it would help them be more efficient during trial setup and provide more benefits to their sites and trial teams.
60% reduction in implementation timelines
The combination of cubeCDMS and cubeIWRS allowed the CRO to set up both systems together, cutting down study start-up time. This synchronization not only sped up the process but also eliminated the need for complex integrations between separate systems.
Enhanced User Experience for Site Users and Data Managers
One of the standout benefits was the streamlined user experience. With both EDC and RTSM functionalities housed within the same platform, site users could now perform randomization and drug allocation directly from the EDC. It reduced the need to navigate between systems and led to increased confidence in the data captured, as the EDC became the single source of truth.
Data Managers were able to access both EDC and RTSM data in the same reports, removing the need for data reconciliation. Reconciling visit dates between EDC and RTSM systems was always a source of frustration for the CRO team.
47% cost reduction in eClinical study budgets on average
By choosing a combined offering, the CRO saw a reduction in overall study costs. CRScube’s integrated solution proved to be a more cost-effective approach, also resulting in completely removing the need for reconciliation between systems EDC and RTSM.
Results
The implementation of cubeCDMS and cubeIWRS resulted in benefits beyond their expectations.
Increased velocityAccelerated time to first patient in (FPI) and improved overall speed for protocol amendments implementation |
Better user satisfactionSite coordinators and data managers especially appreciated the centralization of tasks and data into one system. |
Easier data analysisData managers did not need to perform data reconciliation between EDC and RTSM anymore, resulting in reduction in queries. |
Conclusion
This European CRO’s decision to implement a combined approach with cubeCDMS and cubeIWRS provided them with an integrated, cost-effective, and innovative solution.
The CRO is now more agile in study start-up, protocol amendments and data analysis, and they offer innovative eClinical solutions at a more competitive price. As a result, they have enhanced their operational efficiency and strengthened their position as a leading provider of clinical research services in Europe.
This European CRO’s decision to implement a combined approach with cubeCDMS and cubeIWRS provided them with an integrated, cost-effective, and innovative solution.
