Background

In 2018, one of Korea’s top 5 pharmaceutical companies were facing the critical challenge of streamlining their clinical study design processes. They had been using a global electronic data capture (EDC) system for several years, but they needed to become more efficient during study initiation. They were also looking to reduce the cost of EDC management. They needed a new solution to achieve their goals, whilst supporting their pipeline in oncology and rare diseases.

They initiated an EDC vendor selection process, aiming to address three challenges:

Lengthy study setup times

Getting the electronic case report forms (eCRFs) up and running was time-consuming, often putting study initiation timelines at risk.

Inconsistent data collection

Variability in eCRF design across different studies led to variability in data collection, complicating data analysis and reporting.

Resource intensity

Designing eCRFs from scratch for each new study required significant human resources.

The client sought a solution that could enhance efficiency, maintain consistency, and reduce the resource burden associated with clinical study design.

SOLUTION: cubeCDMS

The client chose cubeCDMS for its robust features and its alignment with their company objectives. The eCRF library function especially, combined with the eCRF copy feature, offered the potential to significantly streamline the EDC design and the setup of clinical studies.

eCRF library function

cubeCDMS’s eCRF library allowed the sponsor’s data management team to create a centralized repository of standardized eCRF templates. This repository included predefined forms and modules tailored to the specific requirements of their phase 2 and phase 3 portfolio.

eCRF copy feature

The eCRF copy function enabled our client to duplicate existing eCRFs from study to study, allowing for minor adjustments rather than designing each form from scratch. As the copied forms and edit checks had been validated during the setup of previous clinical trials, it significantly reduced the amount of testing required by the data management team.

Implementation

Initial setup time and training

Our team provided hands-on training for the sponsor’s clinical operations and data management teams, ensuring they were proficient in utilizing the eCRF library and copy features. The training was provided for free, aligning with their goal to reduce the cost of EDC management.

Standardized templates

cubeCDMS comes with over 50 pre-validated eCRF templates, which gave the data management team a solid foundation to build their studies from. Those templates were designed to capture all necessary data points while ensuring compliance with regulatory requirements.

They gradually incremented the breadth of their own eCRF library within cubeCDMS, by saving the study forms they wanted to reuse.

Results

Reduction in setup time

The time required to design and deploy eCRFs was reduced significantly, allowing for faster study initiations and taking EDC setup off the critical path.

Consistency of data collection

The use of standardized eCRF templates ensured consistency across studies, resulting in easier data aggregation and analysis. The sponsor was able to offer a repeatable experience to their EDC users, which resulted in better accuracy in data capture.

Resource efficiency

The sponsor experienced a significant reduction in the resources required for eCRF design, freeing up staff to focus on other critical tasks.

Decision to expand the use of cubeCDMS

Impressed by the efficiency gains and consistency achieved through cubeCDMS, the sponsor decided to adopt our EDC solution for their entire portfolio of phase 2 and phase 3 clinical trials.

The decision was based on the following factors:

Scalability

cubeCDMS’s robust features and ease of use made it an ideal solution for scaling up to handle their volume of clinical trials.

Support and training

CRScube’s excellent customer support and training programs ensured that their clinical operations and data management teams could leverage the full potential of the system.

Cost effectiveness

The reduction in time and resources needed for eCRF design translated into significant cost savings, making CRScube a financially viable long-term partner.