From Paper to Digital Study Management in Large Patient Registries for CDx Diagnostics
CDx Diagnostics was seeking to identify an EDC platform for its registry studies that would allow them to transition away from manual processes. TrialKit enabled them to design and manage the study in-house with minimal assistance and reduce the burden on their sites with mobile app access.
- Name CDx Diagnostics
- Type Sponsor – Medical Device Diagnostics
- Therapeutic Area Oncology
- Number of Employees >100
- Previous Solution Manual Paper Process
Client Challenge
CDx Diagnostics, a leader in empowering physicians with Innovative Technology to Prevent Esophageal Cancer, One Patient at a Time, was seeking to identify an electronic data capture (EDC) platform for its registry studies. Their previous registry had over 100,000 cases, 80,000 participants, and was conducted using manual data collection and study management processes. As the cleanliness of data is always important, CDx quickly recognized that the data cleansing effort would require a great deal of time and resources. This led them to find an alternative platform for the future. With organizational growth and new leadership interested in improving processes and procedures, CDx’s research team took a step back to determine how they could accomplish this, and EDC technology climbed their list of needs.
CDx required a robust platform that gave them the needed feature and functionality set, combined with specific capabilities for payment tracking and reporting. They wanted a system that could be managed by CDx’s own research coordinator and have all of their studies built in-house. They required an intuitive user interface that would improve adoption, ease-of-use and limit training time and work effort. The selected system and partner company would need to provide the necessary training and ongoing support, as well.
Client Needs
- User-friendly EDC platform with robust feature set
- Payment tracking capabilities
- Powerful reporting suite
- Ability to build studies internally
- Strong customer service and support
- Partner relationship
Resolution
In working with the client to understand their specific pain points, Crucial Data Solutions (CDS) determined that, beyond their previously stated needs, TrialKit’s mobile platform exceeded CDx Diagnostics’ expectations.
Immediately, the utility of TrialKit’s mobile app became clear. It went from being inconsequential to the top of their list of needs. Supporting the registry, there would be over 100 doctors actively entering data on behalf of the sites. The doctors involved in the registry made it clear that they were not willing to participate in the registry if they were NOT able to enter data via their mobile device in a BYOD model.
Additionally, TrialKit’s role-based permissions feature played an important role in providing configurable access to TrialKit access for CDx representatives who were working with the doctors in the field.
After completing training and spending time in the system, the research coordinator was able to build all of their own forms for their study with TrialKit’s drag-and drop builder which CDS assisted them with, when needed. Now, CDx was able to share the study design with their team and make necessary changes quickly and easily. With the study moving forward, CDx was able to have consistent reporting, and data cleanliness was no longer an issue.
CDx required a robust platform that gave them the needed feature and functionality set, combined with specific capabilities for payment tracking and reporting. They wanted a system that could be managed by CDx’s own research coordinator and have all of their studies built in-house. They required an intuitive user interface that would improve adoption, ease-of-use and limit training time and work effort. The selected system and partner company would need to provide the necessary training and ongoing support, as well.
I’ve gotten the cleanest data that I’ve ever worked with [with TrialKit].
Research Coordinator, CDx Diagnostics
The payment management feature improved their processes and the partnership grew strong. Notably, the original negotiated agreement between CDx Diagnostics and Crucial Data Solutions has NOT resulted in any change orders or out of scope situations.
CDx Diagnostics has already taken advantage of the ability to replicate studies in order to reduce their workload and increase efficiencies. The research team reported that Crucial Data Solutions is a true partner to their organization and the relationship is strong.
Results
- Intuitive, user-friendly EDC platform
- Native mobile app assisted in attracting doctors to the study and streamlined the data collection process
- Strong reporting solution
- Payment tracking capabilities has successfully corrected past issues
Client Benefits
As a result of moving forward with TrialKit, CDx Diagnostics has reported many benefits for their registries, from monetary value to ease of use, to features beyond expectation, and more.
- Internal research coordinator was able to build studies with minimal assistance
- CDS Support assists CDx on an ongoing basis
- CDx is informed when new features are added to TrialKit
- Formed a strong partnership with CDS rather than acting simply as a vendor
- No change orders or out of scope issues