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Decentralised Clinical Trials: From Design to Real-World Delivery

By Clinical Data Management Team
November 25, 2025

Decentralised Clinical Trials (1)

Imagine being invited to join a clinical trial that could genuinely make a difference, but the nearest site is hours away, your work schedule is packed, and you have a family member relying on you at home. For many people that decision is not about willingness, it is about practicality. The travel alone becomes a barrier. These are the realities decentralised clinical trials are designed to change.

For years clinical research has relied on a site-led model where every assessment, questionnaire, and conversation requires an in-person visit. It is a system that works for some, but it leaves many behind. Digital tools and new operating approaches are helping the industry rethink that structure. Instead of pulling participants toward the site, decentralised trials bring the study to them.

Video consultations, home nursing visits, wearable devices, and remote assessments have widened access in ways that were not possible a decade ago. The shift accelerated during the pandemic, but it has continued because it reflects a more inclusive and realistic way to conduct research.  This article outlines how decentralised clinical trials work, the regulatory context shaping them, common challenges, and practical design considerations for sponsors and their partners.

What is a Decentralised Clinical Trial (DCT)?

A decentralised clinical trial uses a combination of digital technologies and community-based services to support participation from any location. This can include virtual discussions during consent, home delivery of investigational product, continuous data capture through wearables, or local sample collection. Some trials operate entirely remotely, while others follow a hybrid model that blends digital options with essential on-site assessments. The goal is to protect scientific integrity while reducing the burden placed on participants.

In practice, trials sit on a spectrum from fully site-centric designs, through hybrid models with selected remote visits or assessments, to studies that are almost entirely conducted away from the research centre. Today, most decentralised activity sits in this hybrid middle ground, anchored by an investigator site but extending participation into participants’ homes and local services.

Why the Shift Toward Decentralised Models?

Traditional site-based research assumes participants can travel regularly and fit rigid schedules into their daily lives. Many cannot. Care-giving responsibilities, mobility challenges, shift work, and transport issues often prevent people from taking part. Decentralised approaches flip that model by enabling remote check-ins, digital questionnaires, and community-based procedures that do not rely on proximity to a research centre. This increases participation and broadens the diversity of those taking part.

A Participant-Centric Approach

Decentralisation brings the trial closer to the rhythms of daily life. When participation becomes less disruptive more people can engage meaningfully. This inclusivity and patient-centricity not only strengthens representation but creates data that better reflects real-world experiences. It reinforces a simple idea. Trials should adapt to participants not the other way around.

Operational Efficiency Without Sacrificing Rigour

Virtual visits shorten scheduling delays and digital assessments reduce manual data entry. Continuous data from wearables fills gaps left by infrequent site visits. These improvements do not reduce the need for robust oversight. Clear processes, training, and communication remain central. When implemented thoughtfully decentralised methods streamline operations while maintaining the standards required for regulatory acceptance.

Benefits and Execution Challenges

Decentralised models improve access, support engagement, and provide richer datasets. Participants join without long travel. Mobile apps, sensors, and virtual touchpoints generate near real-time insight. Recruitment becomes smoother and retention more stable.

Challenges arise when decentralised tools do not speak the same language. A wearable may capture raw physiological data, a mobile app may record self-reported symptoms, and a nurse may upload results from a home visit. Without aligned formats or shared structures these inputs become difficult to combine. Regulators expect traceability, consistency, and audit readiness, which makes early planning for data harmonisation essential.

Other concerns include maintaining clear principal investigator oversight for activities performed away from the site, managing medical licensure and product shipment across regions, and ensuring that digital approaches do not exclude participants with limited connectivity, language support, or device access.

Common Challenges and Practical Solutions

Data integrity across multiple technologies remains a central concern in decentralised designs. Different platforms may store similar information in incompatible formats or without the context needed for analysis. Sponsors can reduce this risk by defining common data models early, agreeing standard mappings across vendors, and using near real-time reconciliation to detect discrepancies before they affect decision-making.

Principal investigator oversight is another recurring challenge when activities move away from the physical site. Without clear structures, accountability for safety reviews, protocol adherence, and follow-up can become blurred. Defining delegated tasks in study documentation, using structured teleconsultations for key visits, and maintaining regular safety reviews and monitoring meetings help keep investigators firmly in control of decentralised elements.

Licensure, logistics, and product handling can also become more complex when investigational product is shipped directly to participants or administered at home. Planning country-specific licensure requirements, arranging temperature-controlled shipping where needed, and providing clear, simple instructions for storage and handling at home all help maintain compliance and protect product quality.

Finally, the digital divide risks excluding people with limited access to technology, connectivity, or language support. To keep participation broad and inclusive, teams can offer device provision where appropriate, build offline or low-bandwidth options, provide local visit alternatives for critical procedures, and design multilingual, low-complexity interfaces that are easier to use in everyday life.

Questions Shaping the Maturity of Centralised Trials

  • Are data models consistent across vendors?
  • Who ensures wearable data is standardised?
  • Can discrepancies be detected in near real-time?
  • Does decentralisation introduce variation and how should it be managed?

Operating Model and Tech Stack

A decentralised operating model connects core clinical systems with participant-facing tools and supporting services. Typical components include electronic data capture (EDC) for investigator-entered data, eCOA/ePRO platforms for patient-reported outcomes (PROs), eConsent for remote information and content discussions, telehealth solutions for virtual visits, remote patient monitoring and wearables for continuous data, interactive response technologies (IRT) for randomisation and supply, and eTMF for trial master documentation.

These systems must be tied together through documented data flows, role-based access, audit trails, and validation aligned to requirements such as 21 CFR Part 11 and GDPR. Clear vendor oversight and change management processes help ensure that updates to any one component do not compromise data integrity or participant safety.

From Individual Tools to Unified Decentralised Infrastructure

Many decentralised trials rely on separate point solutions that each handle one aspect of remote data capture. What is needed is a unified environment that can ingest, standardise, and reconcile data regardless of source. Platforms such as Medidata Clinical Data Studio offer this architecture, bringing together EDC records, laboratory feeds, wearable outputs, and patient reported outcomes into a single structured model. Automated quality checks help reduce manual reconciliation and support faster decision-making.

Sponsor Considerations When Designing Decentralised Trials

Sponsors begin by assessing feasibility. This includes digital readiness, the complexity of required procedures, and the balance between remote and on-site activities. Selecting vendors with proven interoperability and clear user support is crucial. Pilot phases and structured training help teams adopt decentralised workflows smoothly. Scaling should be based on real feedback rather than upfront ambition.

Regulatory Alignment

Regulators now provide clearer expectations for decentralised approaches.

The FDA’s 2024 final guidance covers remote assessments, telemedicine, digital technologies, and home delivery of investigational product. It emphasises safety oversight and data reliability.

The EMA’s 2022 recommendations focus on feasibility, consistent procedures, participant protection, and data privacy.

ICH E6(R3) supports decentralised practices through proportionality and modernised oversight.

The HRA and MHRA encourage decentralised methods when supported by strong risk management and documentation.

Across regions the underlying expectations are similar. Trials must have validated systems, clear responsibilities, secure data handling, and transparent protocols for activities that occur outside traditional sites.

The Future of Decentralised Clinical Trials

Hybrid models will remain the most common form of decentralisation because they blend convenience with essential clinical oversight. In the next 12 to 24 months, progress is likely to focus on practical steps such as refining remote visit schedules, improving integration between core platforms, and standardising how digital endpoints are defined and captured.

Over the next few years progress will depend on better interoperability between platforms, clearer standards for digital endpoints, and increased support for sites that deliver decentralised activities. Over a two to four year horizon, wider adoption will also rely on stronger site enablement, clearer expectations for cross-border licensure, and more consistent approaches to training and monitoring decentralised activities. Digital tools will evolve but the real shift will come from integrating them coherently so that decentralised elements feel routine rather than exceptional for sponsors, sites, and participants.

Conclusion

Decentralised trials bring research into people’s everyday environments. When the barriers of travel and scheduling are removed, participation becomes more inclusive and the evidence generated becomes more reflective of real life.

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, submit an RFI below.

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FAQs

Should there be a central location or physical site in a decentralised clinical trial?

Some trials operate fully remotely while others retain a primary site for complex assessments or oversight. Hybrid models provide the flexibility needed for most therapeutic areas.

How is remote data collected in decentralised clinical trials?

Remote data can be captured through wearables, mobile apps, telemedicine consultations, home health services, and electronic questionnaires.

What's the difference between a decentralised clinical trial and a virtual clinical trial?

A virtual trial is completely remote. A decentralised trial is broader and includes any design that moves part of the participant journey away from the site. Most decentralised studies use a hybrid structure rather than a fully virtual one. 


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