Background
A leading Japanese Contract Research Organization (CRO), providing clinical operations and monitoring services in Phase I-IV clinical trials across various therapeutic areas, faced growing inefficiencies in data capture at clinical sites. The reliance on paper-based source documents and subsequent transcription into an Electronic Data Capture (EDC) system led to transcription errors, delayed data entry, and increased source data verification (SDV) costs.
These issues not only hampered data quality but also created misalignment between clinical sites and the CRO’s data management team, leading to bottlenecks in trial execution.
They were looking for a solution to address the following challenges:
Errors and protocol deviationsThe transcription of paper-based source data into the EDC system led to frequent errors, protocol deviations, and inconsistent data. |
Lack of real-time visibilityThe CRO struggled with delays in accessing clinical data, making it difficult to monitor study progress and address issues promptly. |
Time-consuming source data verification (SDV)The reliance on paper-based source documents required frequent on-site monitoring visits, increasing operational costs. |
They turned to CRScube for a solution that would address those challenges.
Solution: implementing cubeDDC
To overcome their data collection challenges, the CRO adopted cubeDDC, CRScube’s tablet-enabled Direct Data Capture (DDC) solution. Designed to integrate seamlessly with cubeCDMS, cubeDDC allowed sites to enter data directly into an electronic system at the point of care, eliminating the need for paper-based records and manual transcription.
cubeDDC was the right solution to address their challenges:
Reduction in errors and protocol deviationsWith real-time edit checks, cubeDDC flagged out-of-range values or missing data at the point of entry. In a Phase II oncology trial that the CRO closely monitored, they noticed an estimated 30% drop in protocol deviations, compared with similar paper-based trials. |
Improved data visibilitySince site-entered data was instantly available in cubeCDMS, the CRO could track patient progress in real time. This allowed the clinical team to identify trends, detect safety signals faster, and proactively manage queries. |
Lower SDV effortBy eliminating paper-based source documents, cubeDDC reduced the need for on-site visits. In a cardiology study, the CRO reported a 50% reduction in SDV efforts, allowing CRAs to focus on risk-based monitoring strategies. |
Seamless integration and easy setup
One of the key advantages of cubeDDC was its integration with cubeCDMS, allowing both systems to be configured in the same unified builder. This streamlined study setup enabled the CRO to initiate studies faster with fewer resources, as study teams could build, validate, and deploy studies in a single environment.
Additional benefits for the CRO
Beyond addressing their initial challenges, the CRO discovered additional advantages of using cubeDDC:
Regulatory compliance and inspection readiness
cubeDDC’s built-in audit trail ensured complete traceability of data entry, making it easier to comply with regulatory standards such as FDA 21 CFR Part 11 and ICH GCP. During an unexpected regulatory inspection, the CRO demonstrated full data integrity, avoiding critical findings.
Faster Adverse Event (AE) reporting
Since data was captured electronically in real-time, safety teams received AE reports more quickly. The time from AE occurrence to reporting was reduced, enhancing patient safety monitoring.
Increased site satisfaction
The CRO was not the only one experiencing the benefits of the cubeDDC implementation. Site users also reported a higher satisfaction, leading to stronger collaboration with the CRO.
Time savingsBy eliminating redundancy, site coordinators saved an average of two hours per patient visit, allowing them to focus more on patient care. |
Reduction in queriesReal-time edit checks and direct data capture reduced the volume of data queries, minimizing back-and-forth communication with CRAs. |
Strengthened CRO-site relationshipSite staff welcomed the ability to remove paper source data capture. Several sites expressed an interest in working with the CRO again. |
Conclusion
Based on the tangible benefits observed – reduced protocol deviations, increased site satisfaction, faster AE reporting, and lower SDV costs – the CRO decided to implement cubeDDC across all their studies.
This transition optimized data capture workflows, improved site relationships, and strengthened collaboration between sites, CRO teams, and sponsors. The adoption of cubeDDC positioned them as a leader in digital clinical trials, demonstrating their commitment to innovation and operational excellence.
The reliance on paper-based source documents and subsequent transcription into an Electronic Data Capture (EDC) system led to transcription errors, delayed data entry, and increased source data verification (SDV) costs.
Site solutions
Improving the clinical data capture process with cubeDDC
Protocol deviations
Data quality
Effort reduction