A certifiable evidence-chain digital platform supporting decentralized clinical trials: architecture and real-world evaluation

Decentralized clinical trials (DCTs) can improve participant accessibility and trial efficiency, yet real-world implementation is often limited by fragmented systems, repeated data transcription, and insufficient auditability. We developed and evaluated a digital clinical trial platform that can support DCTs through a traceable, verifiable, and analyzable evidence chain in real-world settings. The platform integrates structured eSource, electronic informed consent, ethics review, off-site follow-up, smart drug cabinet, controlled documentation, electronic verified copies, remote monitoring, and automated statistical analysis, among others, thereby forming a closed loop from preparation to execution, monitoring, governance, and analysis. In a historical comparison at a leading center (pre-platform period: 2018.11-2021.06 vs post-platform period: 2025.01-2025.12), the median time from project application submission to project initiation was reduced from 156.0 to 75.0 days (51.9% reduction, P < 0.001). The platform supported 2510 trials with 34,256 participants, including both trials without decentralized elements (2436) and those incorporating decentralized elements (74). The platform, implemented in hybrid clinical trial settings, is designed to provide a scalable and compliant framework for integrating decentralized elements into site-based workflows, supporting more flexible and efficient clinical research.