Scaling eSource for late phase clinical trials

Background

CMIC, the largest Clinical Research Organization (CRO) in Japan, began adopting Direct Data Capture (DDC) in clinical trials in 2019 and integrated cubeDDC into its trial operations in 2022. However, expanding DDC across late-phase, multicenter patient trials presented significant operational hurdles due to conflicting routine medical care workflows and varying institutional practices across clinical sites.

To achieve full-scale implementation, CMIC redesigned its operational framework to accommodate real-world site constraints while leveraging the full capabilities of CRScube’s eSource data capture solution, cubeDDC, combined with its EDC, cubeCDMS.

The primary challenges driving this operational redesign included:

CMIC decided on a process-led approach that leveraged cubeDDC at its core.

Solution: Field-integrated framework

CMIC treated DDC not merely as a data entry tool, but as a holistic clinical trial management process designed to integrate seamlessly into routine patient care.

To ensure widespread site adoption, CMIC focused on three strategic pillars:

Establishing the "First Record" concept

CMIC collaborated with sponsors to define a structured data entry methodology. Instead of treating DDC entry as simple transcription, Clinical Research Coordinators (CRCs) cross-reference and organize scattered source materials – such as medical records, medication logs, and referral letters – before logging them into the CRF as an official "First Record."

Optimized role delegation and verification timing

To reduce physician workload without sacrificing data quality, CRCs handle routine data entry for physicians to review in a timely manner. Physicians directly input only key clinical assessments, such as eligibility evaluations and adverse events. Clear visual cues in cubeDDC guide each user to their assigned tasks, preventing role confusion.

Flexible site adoption models and dedicated support

Recognizing that site capabilities differ, CMIC offered tailored operational integration, allowing full DDC entry, partial DDC with preliminary worksheets, and traditional workflows where needed. To ease early-phase adoption during first-patient visits, CMIC provided site-specific FAQs and dedicated hands-on follow-up.

Results

Adopting a site-centric operational strategy delivered significant efficiency and visibility improvements across multicenter trial sites:

One of CMIC’s clinical operations staff summarized the benefits very well:

"The value of DDC extends beyond reducing paperwork.

Real-time visibility into entry and verification history makes trial oversight substantially easier, particularly when onboarding sites during their first patient visits.

By maintaining physician input for key clinical judgments while delegating routine entry to CRCs, we achieved significant workload reduction without compromising quality."

To further refine site usability, CMIC continues to optimize workflow design, focusing on consolidating physician review checkpoints and enabling parallel page referencing to streamline CRC data matching for concomitant medications and medical histories.

Moving forward, CMIC aims to build upon this foundation by further harnessing real-time trial data to drive continuous operational performance and deliver greater value to sponsors and investigative sites alike.