Decentralised Clinical Trials & Device Infrastructure

What is changing in decentralised clinical trials?

Decentralised and hybrid clinical trials are changing the role of technology in clinical research.

Remote participation, eCOA, ePRO, telehealth and connected data collection increasingly mean that critical study activities can take place outside the traditional clinical site.

That creates an important infrastructure question: What happens when the smartphone becomes part of the clinical trial environment?

For sponsors, CROs and clinical technology providers, the answer cannot begin and end with choosing an app. The device running that application, its operating system, connectivity, battery, security configuration, lifecycle, availability and replacement strategy can all influence the consistency of the participant experience.

Clinical-trial devices therefore need to be considered as infrastructure, not simply accessories. This is the environment STK Life is designing for.

Why is device infrastructure important in clinical trials?

When a participant completes an ePRO assessment, receives a study reminder, performs an identity workflow or interacts with a clinical trial application remotely, the physical device becomes part of the data-capture chain.

That introduces variables that clinical operations teams need to consider. Different smartphone models can have different:

• operating-system versions
• screen sizes and interfaces
• battery characteristics
• security-update schedules
• radio and network configurations
• background application behaviour
• manufacturer support periods
• replacement availability

In everyday consumer use, these differences may be manageable. Across a multinational clinical trial involving hundreds or thousands of participants, they can become an operational challenge.

The question is not simply whether a smartphone works today. It is whether the required device environment can remain consistent, supportable and replaceable throughout the study.

BYOD or provisioned devices: which approach is right for a clinical trial?

There is no universal answer. Bring Your Own Device, or BYOD, can be appropriate for many studies. It can reduce the number of devices distributed and allow participants to use technology they already understand.

But BYOD also introduces variability. Participants may have different operating systems, older smartphones, limited storage, different connectivity arrangements or devices that do not meet a study's technical requirements. Some participants may not own an appropriate smartphone at all, or may prefer not to use a personal device for research participation.

That is where provisioned clinical trial devices continue to play an important role. A provisioned-device strategy can provide sponsors and CROs with a more controlled environment for:

• eCOA and ePRO applications
• remote study participation
• device configuration
• application management
• connectivity
• troubleshooting
• replacement
• study-specific workflows

The decision should be based on the protocol, participant population, geography, technical requirements and study design. In many cases, the answer will not be BYOD or provisioned devices. It will be a considered combination of both.

Why can consumer smartphone lifecycles create clinical-trial risk?

Consumer smartphones are designed around consumer-market cycles. Clinical trials are not.

A device selected during study planning may need to remain available and supportable for several years. During that period, a consumer handset can be replaced by newer generations, components can change, software support can evolve and the original specification can become difficult to source.

For a clinical trial, that can create practical questions. What happens if a participant needs a replacement device two years into the study? Can the same model still be supplied? Will the replacement run the same operating-system configuration? Will application behaviour remain consistent? Can security updates and firmware be managed throughout the required lifecycle?

These are not simply IT questions. They are operational continuity questions. A long-running clinical study should not have to inherit the lifecycle assumptions of the consumer smartphone market. Purpose-built clinical-trial device strategies allow lifecycle planning to begin much earlier.

What role will AI play in clinical trial devices?

The most useful application of AI in clinical research may not always happen in a large cloud platform. Some capabilities can potentially operate directly on the participant's device.

On-device AI can be designed to process certain information locally, opening possibilities for faster workflows, reduced dependence on constant cloud communication and more privacy-conscious forms of processing.

The important distinction is between practical AI capabilities and generic AI claims. For clinical research, relevant areas may include:

• participant engagement and reminders
• multilingual interaction
• biometric identity workflows
• voice-based workflows
• image-capture guidance
• passive signal capture
• edge processing and on-device inference

These applications remain subject to the requirements of individual studies, validation processes and applicable approvals.

STK Helix and STK Cortex™

STK Helix has been developed as a purpose-built 5G AI-native smartphone for clinical research and life sciences deployments. Helix is the hardware foundation. Cortex is the AI capability layer.

STK Cortex™ is being developed as the evolving AI capability layer for Helix, allowing capabilities to be introduced in a structured way rather than treating AI as a single feature.

The Cortex roadmap is designed to support areas including on-device AI, identity workflows, participant reminders, multilingual engagement, passive signal capture, voice workflows and standardised image capture. Roadmap capabilities should not be confused with functionality available in every deployment. Their use will depend on the relevant Cortex release, study configuration, validation and applicable requirements.

The principle is straightforward: AI should solve defined clinical-research workflow problems, not be added simply because AI is fashionable.

Why does connectivity matter in a global clinical trial?

Moving a study beyond the clinical site also moves connectivity into the infrastructure discussion. A participant-facing device that cannot reliably connect when required can create additional support burden and potentially interrupt remote workflows.

International studies make that challenge more complicated. Different countries can involve different mobile networks, SIM arrangements, roaming conditions, certifications, charger requirements and logistical processes. For study teams, this can mean managing multiple variables across different markets.

STK Nexus™ is STK Life's global connectivity proposition, designed to support physical SIM, eSIM and multi-network connectivity requirements for international deployments. The objective is not connectivity for its own sake. It is simpler, more manageable deployment of patient-facing devices across multiple study locations.

How can technology reduce participant burden?

Patient-centric technology is not simply technology with a better interface. It starts with understanding what the participant is being asked to do.

For some people, downloading an application onto a personal smartphone will be straightforward. For others, it may introduce technical, financial, accessibility or privacy concerns. Participants may have:

• an incompatible smartphone
• limited mobile data
• an older operating system
• accessibility requirements
• limited technical confidence
• shared access to a household device
• concerns about using their personal phone for a study

A provisioned smartphone can provide another route into remote research participation. It can also give study teams greater control over the starting environment, helping reduce differences between participant configurations.

That does not make provisioned devices automatically preferable to BYOD. It makes choice of device strategy part of patient-centred trial design. Digital inclusion requires more than making an application available. It requires considering whether participants can realistically access and use it.

What does sustainability mean for clinical-trial device programmes?

Sustainability discussions around clinical technology should extend beyond packaging and shipping. Device selection affects the complete technology lifecycle.

Sponsors and technology partners should consider questions such as:

• How long does the hardware need to remain supported?
• Can unnecessary model changes be avoided?
• How will replacement devices be managed?
• What happens to hardware after a study?
• Can devices be responsibly recovered or recycled?
• Can international logistics be simplified?
• Can better lifecycle planning reduce unnecessary hardware movement?

These questions increasingly sit alongside cost, availability, reliability and operational risk. A more sustainable device programme begins with better planning, not sustainability messaging.

Why manufacturing expertise matters in clinical research

There is an important difference between supplying a smartphone and understanding how that smartphone is built. STK has been designing and manufacturing mobile devices since 1993.

That manufacturing perspective changes the conversation around clinical-trial technology because issues such as component selection, firmware, operating-system configuration, certification, quality assurance and lifecycle planning can be considered at device level.

STK's experience also includes the STK X3 Smartphone, which was supplied into life sciences environments and helped shape the company's next generation of clinical-trial devices. STK Helix builds on that experience.

Rather than adapting its strategy around whichever consumer handset happens to be available, STK Life is developing purpose-built mobile device infrastructure around the operational requirements of clinical research.

What should sponsors and CROs ask a clinical-trial device provider?

Device procurement should involve more than comparing specifications and purchase prices. Before selecting hardware for a decentralised or hybrid study, teams should consider questions including:

• Lifecycle: How long will the device remain available and supported?
• Replacement: What happens when a device is lost, damaged or fails during the study?
• Operating system: How will updates, firmware and application compatibility be managed?
• Connectivity: How will devices connect across different countries and networks?
• Provisioning: Can study applications and configurations be applied consistently?
• Certification: What market-specific requirements need to be addressed?
• Patient experience: Is the device appropriate for the intended participant population?
• Scale: Can the same technology strategy support expansion into additional countries?
• AI: Which capabilities are actually available, which are planned, and what validation or approvals may be required?

These questions turn device procurement into infrastructure planning. That distinction matters increasingly as clinical research becomes more digital, distributed and dependent on patient-facing technology.

From devices to clinical-trial infrastructure

The next phase of decentralised clinical trials will not be defined by adding more individual technologies. It will be defined by how well those technologies work together.

Applications need hardware. Hardware needs connectivity. Connectivity needs international deployment planning. Participants need reliable and accessible experiences. Study teams need consistency, support and replacement strategies. And increasingly, AI capabilities will need a dependable device environment in which they can operate.

This is why STK Life views the smartphone differently. Not as a generic consumer product repurposed for a study, but as part of the technology infrastructure supporting modern clinical research.

Purpose-built mobile device infrastructure for global clinical trials. STK Helix is being developed around that principle, combining STK's mobile-device manufacturing experience with the requirements of decentralised trials, eCOA, ePRO and patient-facing data collection. Because when the trial moves beyond the site, the device moves closer to the centre of the study.

Frequently Asked Questions

What is a provisioned device in a clinical trial?

A provisioned device is a smartphone, tablet or connected device supplied specifically for use in a clinical study. It can be configured with the required applications, settings, connectivity and device-management policies to provide participants with a more consistent study environment.

Are provisioned devices better than BYOD for clinical trials?

Not necessarily. BYOD and provisioned-device strategies have different advantages. BYOD may reduce device distribution and allow participants to use familiar technology. Provisioned devices can improve consistency and provide access for participants who cannot or do not wish to use their personal smartphone. The appropriate approach depends on the study.

Why use a purpose-built smartphone for clinical trials?

A purpose-built device can be developed around clinical-research requirements such as lifecycle planning, provisioning, application control, connectivity, replacement availability and patient-facing workflows rather than relying entirely on consumer-market device cycles.

What is STK Helix?

STK Helix is a purpose-built 5G AI-native smartphone developed by STK for decentralised and hybrid clinical trials, eCOA/ePRO data capture, remote participation and life sciences deployments.

What is STK Cortex™?

STK Cortex™ is the evolving AI capability layer for STK Helix. Helix provides the hardware foundation, while Cortex is being developed to support AI-enabled clinical research workflows. Individual capabilities are subject to release status, study requirements, validation and applicable approvals.

How can AI be used on clinical-trial smartphones?

Potential applications include on-device inference, participant reminders, multilingual engagement, biometric identity workflows, passive signal capture, voice workflows and image-capture guidance. These capabilities should support defined clinical-research processes and should not be positioned as replacing clinical judgement.

What is STK Nexus™?

STK Nexus™ is STK Life's connectivity proposition for global device deployments, supporting physical SIM, eSIM and multi-network connectivity requirements.

Does STK Helix diagnose or treat patients?

No. STK Helix is designed to support clinical research infrastructure and data-capture workflows. It is not positioned as diagnosing, treating or preventing disease, or as replacing clinical decision-making.