We specialize in the creation of private label and custom Android device solutions
Clinical trials generate enormous volumes of patient data, and increasingly, that data starts on a mobile device. Over the past decade, the industry has moved away from paper-based data collection toward provisioned, purpose-configured Android handsets that patients carry at home and site coordinators use across hundreds of trial locations worldwide.
That shift has made the device itself a critical variable. The wrong hardware choice creates compliance gaps, data integrity issues, and logistical headaches that can slow a trial or compromise its results. The right one disappears into the background, reliable, secure, and built around the needs of the trial.
This guide covers what clinical trial devices actually need to do, who selects them, and why Android has become the platform of choice for sponsors, CROs, and the 3PLs who put devices in patients’ hands.
TL;DR: Key Takeaways
The global clinical trials market was valued at approximately $65 billion in 2025, and the technology infrastructure supporting those trials has grown alongside it. Sponsors are running larger, more geographically distributed studies, and the logistics of collecting reliable data across hundreds of sites in multiple countries have made standardized, provisioned devices a core operational requirement rather than a nice-to-have.
The shift toward decentralized and hybrid trial models has accelerated this. The decentralized clinical trials market is projected to nearly double by 2030, reflecting a broader move away from site-centric research toward patient-centric models where the device in a participant’s home becomes the primary data collection point. That puts new pressure on hardware selection as the device needs to work consistently, stay secure, and keep a patient engaged over a trial that may run for years.
Device decisions in this ecosystem typically flow through three layers. Pharmaceutical sponsors set the protocol requirements and compliance mandates. CROs like IQVIA, ICON, Parexel, and Syneos Health translate those requirements into vendor selection and device management strategy. 3PLs including McKesson, DHL, and UPS Healthcare handle the physical side: provisioning, distributing, and recovering devices across trial sites. Each layer has different priorities, but all three depend on hardware that is reliable, configurable, and compliant from day one.
Not all clinical trial devices serve the same function, and understanding the distinctions matters when evaluating hardware requirements.
eCOA, or Electronic Clinical Outcome Assessment, is the umbrella category covering all electronic methods of capturing clinical outcome data. This includes data reported by patients, clinicians, caregivers, and performance-based assessments recorded during structured tasks.
eCOA replaced paper-based data collection because electronic capture produces more accurate, complete, and auditable records, an important distinction in a regulatory environment where incomplete or inconsistent data can delay approvals or invalidate a study. The FDA has made its preference for electronic data collection clear in its guidance on clinical outcome assessments, and paper-based collection is now the exception rather than the rule.
ePRO, or Electronic Patient-Reported Outcomes, is the most common eCOA application in decentralized and hybrid trials. It covers data reported directly by participants: symptom diaries, quality-of-life assessments, medication logs, and adverse event tracking completed between clinic visits.
Because ePRO relies on patients self-reporting from home, the device they use becomes a critical part of the data collection infrastructure. It needs to be simple enough for a broad patient population to use consistently, durable enough to last the full trial duration, and locked down tightly enough to ensure data is captured as intended without interference from other apps or settings.
Many trials go beyond self-reported data and integrate connected sensors and wearables — continuous glucose monitors, cardiac patches, blood pressure cuffs, and biosensors that transmit physiological data in real time. In these configurations, the provisioned Android handset sits at the center of the data flow, pulling readings from peripheral sensors and routing them securely back to the trial’s data management platform.
That role puts specific hardware demands on the device, including reliable Bluetooth connectivity, background data sync across variable network conditions, and a security framework that protects sensitive biometric data end to end.
A provisioned clinical trial device is not a general-purpose smartphone. It has a specific job, and the hardware and configuration choices made before it reaches a patient or site coordinator directly affect data quality, regulatory compliance, and trial outcomes. Getting those choices wrong can be expensive. Replacing devices mid-trial, managing compliance gaps, or dealing with inconsistent data across sites creates problems that are difficult and costly to fix. The core functional requirements are:
Clinical trial devices are typically configured in kiosk mode, restricting the device to the trial’s ePRO or eCOA application and nothing else. This prevents participants from accidentally. or intentionally, navigating away from the trial app, modifying device settings, or introducing variables that could compromise data integrity.
For sponsors and CROs, kiosk mode is a must have feature; it is a core control that ensures data is captured as the protocol intends.
Large-scale trials can span hundreds of sites across multiple countries, with thousands of devices in circulation simultaneously. MDM enrollment allows trial operators to configure, monitor, update, and troubleshoot every device remotely from a single console, without requiring on-site IT support.
This matters throughout the trial lifecycle: from initial provisioning before devices ship, to pushing app updates mid-study, to remotely wiping devices when participants complete or withdraw from the trial.
Every data point collected on a clinical trial device needs to meet the FDA’s requirements for electronic records under 21 CFR Part 11, meaning records must be attributable, legible, contemporaneous, original, and accurate. At the device level, this translates to encrypted data storage, timestamped entries, and access controls that prevent unauthorized modification of trial data.
Hardware that cannot support these controls creates compliance risk that no software layer can fully compensate for.
Clinical trials are long. Phase III studies routinely run for two to four years, and a device that ships to a participant at enrollment needs to perform consistently until the trial closes. That means durable hardware, stable battery performance, and the ability to operate reliably across variable network conditions, whether a participant is in an urban hospital network or a rural area with limited connectivity.
Platform choice matters more than it might initially appear. While both Android and iOS are capable of running ePRO and eCOA applications, Android has become the dominant choice for provisioned clinical trial devices.
Android’s open architecture gives sponsors, CROs, and device partners far greater control over how a device is configured and locked down for single-purpose use. Kiosk mode, custom launchers, pre-loaded app environments, and deep MDM integration are all significantly more flexible on Android than on iOS, where Apple’s closed ecosystem places limits on how far a device can be modified for dedicated use. For clinical trials, where standardization across every device in a study is a core data integrity requirement, and Android’s flexibility makes that standardization considerably easier to achieve at scale.
The major ePRO and eCOA software vendors build their platforms to run on Android, and the open ecosystem makes integration with third-party applications and connected sensors considerably more straightforward than on iOS.
Sponsors do not need to choose between their preferred clinical software and their preferred hardware, and on Android the two tend to work together without the compatibility friction that comes with a closed platform.
A Phase III trial with thousands of participants across multiple countries requires thousands of provisioned devices. The majority of clinical studies using ePRO use a provisioned device model, meaning device costs can add up fast across a large study.
Android hardware offers a significantly wider range of price points than iOS, allowing sponsors and CROs to select devices that meet their technical requirements without paying for features a trial does not need.
NUU sits on the hardware side of the clinical trial technology stack. The ePRO and eCOA applications belong to the clinical software vendors. NUU provides the physical device those applications run on, configured and provisioned to meet the specific demands of a trial.
That distinction matters. A generic off-the-shelf Android device can run an ePRO application, but it cannot arrive at a trial site pre-configured, locked to a single app, enrolled in an MDM platform, and ready for immediate patient use without additional setup. NUU’s enterprise Android devices and customization capabilities are built precisely for that kind of deployment, where every device in a fleet needs to behave identically from day one, across hundreds of sites in multiple countries.
The specific capabilities that translate directly to clinical trial use cases include:
NUU’s custom device work extends beyond configuration. Where a trial requires hardware that does not exist as a standard commercial product, NUU can build it. The clearest example of this in a healthcare context is NUU’s development of a device that functioned as a controller for an insulin delivery system, a purpose-built solution that emerged from a specific clinical need rather than an off-the-shelf product. That same capability applies to any trial requiring a device that integrates with proprietary sensors, wearables, or monitoring equipment in ways that standard hardware cannot support.
If you are evaluating Android device options for an upcoming clinical trial, get in touch with the NUU team to discuss your program’s specific hardware and configuration requirements.
eCOA (Electronic Clinical Outcome Assessment) is the umbrella category covering all electronic methods of capturing clinical outcome data, including assessments completed by patients, clinicians, caregivers, and performance-based tests. ePRO (Electronic Patient-Reported Outcomes) is a subset of eCOA that covers data reported directly by trial participants — symptom diaries, quality-of-life questionnaires, and similar self-reported measures. In practice, ePRO is the most common application of eCOA in decentralized trials and the primary use case for provisioned patient devices.
The key standards are 21 CFR Part 11, which governs FDA requirements for electronic records and signatures; GCP (Good Clinical Practice), which sets expectations for data integrity and device standardization across trial sites; and HIPAA, which governs the handling of patient health data at the device level. Devices must support encrypted data storage, audit trails, and access controls to meet these requirements.
Android’s open architecture gives sponsors and device partners significantly more control over how devices are configured and locked down for single-purpose use. MDM integration, kiosk mode, and custom app environments are all more flexible on Android than on iOS. Android also offers a wider range of hardware price points, which matters considerably when provisioning devices at the scale a large multi-site trial requires.
Commercial Android devices can be used in trials when properly configured, enrolled in MDM, locked to the trial application, and set up with the appropriate security controls. However, for trials requiring integration with proprietary sensors, custom hardware features, or a branded patient experience, purpose-built devices offer capabilities that commercial off-the-shelf hardware cannot match.
Sign up to receive emails for new device launches, industry news, as well as notifications about closeout savings.
location – keep blank
Your email
This website uses cookies to improve user experience. By using our website you consent to all cookies in accordance with our Cookie Policy. Read more
Strictly necessary
Strictly necessary cookies allow core website functionality such as user login and account management. The website cannot be used properly without strictly necessary cookies.
Performance
Performance cookies are used to see how visitors use the website, eg. analytics cookies. Those cookies cannot be used to directly identify a certain visitor.
Targeting
Targeting cookies are used to identify visitors between different websites, eg. content partners, banner networks. Those cookies may be used by companies to build a profile of visitor interests or show relevant ads on other websites.
Cookies are small text files that are placed on your computer by websites that you visit. Websites use cookies to help users navigate efficiently and perform certain functions. Cookies that are required for the website to operate properly are allowed to be set without your permission. All other cookies need to be approved before they can be set in the browser.