An Introduction to Decentralised Clinical Trials [Video]

Decentralised clinical trials use remote, local or digital methods so that selected activities can take place outside the traditional investigator site. This can make participation more practical, but it also changes how sponsors manage data, safety oversight and product supply. The approach needs to reflect the protocol, endpoints, safety profile and participant population.

WHAT THIS VIDEO COVERS
• Why decentralisation is usually a spectrum rather than a fully remote model
• Selecting suitable remote activities during early study design
• Participant burden, digital access and practical support
• Ownership, context and reconciliation across multiple data sources
• Investigator responsibility, delegated tasks and safety escalation
• Risk-based planning for off-site investigational product supply

For each remote or local activity in a decentralised clinical trial, teams need to define who owns the data, who reviews it and what happens when an issue arises. Starting with feasibility rather than a preferred technology can help identify operational gaps before enrolment begins.

Quanticate’s clinical data management team specialises in harmonising remote datasets, applying CDISC-aligned standards, and delivering continuous quality monitoring across decentralised studies. If you want to explore how we can support the operational and data strategy of your decentralised trial, request a consultation below.