From theory to routine: AI-supported decentralized clinical trials

The promise of decentralised and hybrid clinical trials is no longer speculative—it is here, and it is reshaping how medical device studies are designed, conducted, and monitored. Yet for many sponsors, the leap from traditional site-centric models to AI-enabled, patient-centric designs remains a daunting regulatory and operational puzzle. At MEDIACC, we are closing that gap.

Under the Medical Device Regulation (MDR) and ISO 14155:2020, clinical investigations must demonstrate robust performance and safety data, often requiring adaptive, real-world evidence generation. The EU AI Act Adds another layer: AI systems used in trial conduct—whether for automated monitoring, risk-based quality assurance, intelligent visit scheduling, or continuous analysis of wearable-generated data—are now classified by risk. High-risk AI demands conformity assessment, human oversight, and transparent governance before deployment. This is not a barrier; it is a framework for trustworthy innovation.

We currently translate these complex requirements into actionable strategy. Sponsors need support transitioning from classical trials to decentralised models, ensuring MDR compliance while integrating AI-driven efficiencies. Designing fully digital or hybrid protocols leverage remote monitoring and digital endpoints without sacrificing data integrity or patient safety.

But technology alone is insufficient. Sites must be equipped to interpret AI-generated signals, distinguish meaningful anomalies from noise, and maintain ISO 14155-compliant oversight. That is why tailored training concepts are needed: teaching investigators and clinical research staff how to read, evaluate, and act upon AI-augmented monitoring outputs within a robust quality management system. And additionnally, all results must be measurable.

The future of clinical research is decentralised, digital, and intelligently automated. As CRO Partner, MEDIACC ensures that transition is not merely theoretical but routine, compliant, and scientifically rigorous. Let us discuss how your next study can move from Blueprint to Breakthrough.

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