The Rise of Patient-Centric, Decentralized Trials

Clinical research is undergoing a transformation as decentralized clinical trials (DCTs) move into the mainstream. Traditionally, in-person site visits have been a major hurdle – even in recent years, only about 5% of Americans have participated in trials, with 70% living over two hours from a study site, limiting access for many patients. DCTs change this dynamic by bringing trials to patients’ homes and local communities through digital technology. What began as a stopgap during the pandemic has become “an integral part of modern study design,” offering greater accessibility, efficiency, and flexibility in how trials are run. Reflecting this shift, the global DCT market is projected to soar from $9.5 billion in 2024 to over $38 billion by 2034, as sponsors invest heavily in technologies like telehealth, wearables, and remote data platforms.

Regulators are encouraging this evolution. The Food and Drug Administration’s (FDA) final 2024 guidance on DCTs affirmed support for decentralized methods, providing clarity on how to maintain data integrity and patient safety outside traditional sites. Early adopters are already reporting impressive gains: decentralized approaches have delivered up to 50% faster enrollment and 10–25% trial cost reductions by expanding reach and reducing site overhead. Automated, real-time data capture in DCTs is also improving data quality and speeding analysis, helping identify issues sooner.

For sponsors and clinical operations leaders, the message is clear – decentralized trial technologies can dramatically improve patient engagement, data quality, trial efficiency, and even regulatory compliance. Below, we delve into the top innovations driving DCT success in 2025, from wearable health sensors and telemedicine visits to remote ePRO data capture and integrated digital platforms and analyze how each is reshaping clinical development.

 

Wearable Technology for Real-Time Monitoring

Wearable health devices – from fitness trackers and smartwatches to medical-grade sensors – are revolutionizing how trial data is collected. These tools enable continuous, real-time monitoring of key patient metrics (e.g. heart rate, glucose levels, activity and sleep quality) during the trial. By seamlessly streaming biometric data to researchers, wearables provide a more comprehensive picture of patient health between clinic visits. This not only yields higher data precision but also enhances patient safety: any concerning trends or anomalies can trigger alerts for the study team to intervene quickly.

Importantly, wearables also boost patient engagement and adherence. Equipped with devices that let them actively manage and track their health, patients feel more empowered – which in turn keeps them more invested in the study. In fact, allowing participants to monitor their own data has been shown to increase adherence and retention by reducing the burden of frequent site visits and manual diary entries. One leading DCT provider, Medable, reported that integrating wearable sensors for remote patient monitoring led to a 30–40% improvement in patient retention across multiple studies. Wearables effectively “reduce the burden of clinic visits and manual reporting, streamlining data collection and improving the participant experience.” By collecting objective health data in the background, these devices also minimize reliance on sporadic site assessments or patient recall, thereby improving data accuracy.

Looking forward, wearables are set to become even more powerful when combined with analytics. Trial platforms are starting to incorporate AI to sift through the continuous data streams, offering predictive insights (for example, forecasting adverse events or identifying non-adherence) that can further personalize patient support. For sponsors, the takeaway is that wearable tech is a vital enabler of fully decentralized and hybrid trials, delivering richer real-time data and keeping patients actively engaged outside the clinic walls.

 

Telehealth Integration for Remote Patient Visits

Telehealth has emerged as a cornerstone of decentralized trials, enabling virtual clinic visits through video conferencing and remote monitoring. Instead of traveling to a distant site, patients can now consult with investigators from the comfort of home. This dramatically lowers participation barriers – especially for those in rural or underserved areas – and has a direct impact on recruitment and retention. Remote visits and telemedicine make trials far more convenient. By minimizing logistical burdens like time off work, transportation, or childcare, telehealth encourages a broader range of patients to enroll and stick with the study.

Real-world results back this up. In one fully decentralized Phase IV oncology trial, a top pharma sponsor replaced traditional site visits with telehealth consultations, mobile nursing visits, and ePRO data collection. The outcome was a 96% patient retention rate, roughly a 30% improvement over typical retention (~70%) in comparable site-based trials. This virtual design not only kept nearly all patients engaged to completion, but also accelerated study start-up and cut operational costs for the sponsor. Such success stories show how remote visit models can curb the high dropout rates plaguing many studies. Patients are simply more likely to stay in a trial when the trial comes to them.

Telehealth integration also contributes to greater trial diversity and equity. By eliminating geographic barriers, decentralized trials can include patients who historically could not travel to academic medical centers – for example, those from rural communities or underserved urban areas. This leads to more representative study populations. As one analysis observed, DCT approaches have enabled faster-than-expected enrollment timelines and a significantly higher inclusion of diverse demographics, because participants can join “regardless of location.” Regulators recognize this benefit: FDA guidance explicitly allows telehealth visits and local healthcare providers in DCTs, provided investigational oversight and data quality are maintained. With proper protocols, remote visits can be conducted safely and in compliance with GCP, ensuring patients receive the same level of care and monitoring as in-person visits.

In short, telehealth is transforming trial operations by expanding access and keeping patients engaged. Sponsors adopting telemedicine in trials can reach more patients (faster recruitment), keep those patients active through convenient virtual check-ins (higher retention), and ultimately collect complete data sets from a diverse cohort – all while maintaining trial rigor.

 

Remote ePRO and eCOA: Streamlined Data Capture from Anywhere

Another game-changing technology in DCTs is the use of remote electronic data capture tools – notably electronic patient-reported outcomes (ePRO) and electronic clinical outcome assessments (eCOA). These digital systems allow participants to report their symptoms, side effects, and quality-of-life metrics through smartphone apps or web portals, rather than paper diaries or in-person interviews. The result is a more efficient and high-quality data collection process that benefits both patients and sponsors.

Digital outcome collection dramatically simplifies the patient experience. Participants can complete questionnaires or daily diaries on their own device, on their own schedule – receiving automated reminders and prompts that improve compliance and adherence to the protocol. For example, a patient can be pinged each evening to report any symptoms, ensuring timely, time-stamped entries that reduce recall bias compared to paper logs. This not only keeps patients engaged (by giving them an easy, convenient way to contribute data), but it also means fewer missing data points and more accurate outcomes for the study. In fact, replacing clunky paper forms with ePRO/eCOA has been shown to “improve data quality, enhance protocol compliance, and support real-time access to outcomes data.” Every entry is securely time-marked and uploaded, providing investigators instant visibility into patient status between visits.

From the sponsor’s perspective, real-time electronic reporting yields cleaner and more credible data. Transcription errors are eliminated (since data goes directly from patient to database), and any concerning responses can trigger immediate alerts or queries. Data quality is markedly improved, and audit trails are automatically captured for regulatory compliance. As one industry analysis summarized, “digital innovations such as ePRO and eCOA are streamlining clinical trials, boosting participant engagement, and improving data quality and compliance while enabling real-time insights.” For instance, if a patient indicates a severe side effect on an ePRO app, the site can be notified at once and take action, rather than finding out at the next scheduled visit. This kind of responsiveness enhances patient safety and data integrity.

Furthermore, remote eCOA solutions often integrate with other DCT tools (like wearables and EHR data) to give a holistic view of patient outcomes. They can be deployed in fully virtual trials or used to complement on-site assessments in hybrid designs. Either way, the efficiency gains are significant: patients spend less time on paperwork and travel, while study teams spend less time on data entry and monitoring for missing forms. A fully integrated eCOA platform can even work offline and sync later, ensuring flexibility. Overall, electronic outcome capture reduces burden, increases engagement, and delivers higher-quality data than traditional methods. Biopharma sponsors who leverage ePRO/eCOA in their trials often find that not only is data collection more efficient, but regulators and stakeholders have greater confidence in the data since it’s contemporaneous and auditable.

 

Integrated Platforms and Tech-Enabled CROs Leading the DCT Charge

Successfully running a decentralized trial requires more than individual point solutions – it demands an orchestrated platform that ties all the digital threads together. Recognizing this, many leading vendors and contract research organization (CROs) have developed end-to-end DCT platforms that combine patient-facing apps, data integration, and virtual trial management in one cohesive system. These platforms are becoming the backbone for sponsors looking to implement DCT at scale, offering unified oversight and ensuring that the myriad decentralized components operate in sync.

Medidata, for example, has built one of the most comprehensive DCT platforms in the industry. Part of Dassault Systèmes, Medidata’s cloud-based system unifies eConsent, ePRO/eCOA, wearable sensor integration (via its Sensor Cloud), telehealth, and more – all anchored to its Rave EDC database. By “unifying data capture tools and analytics on one platform,” sponsors gain access to real-time intelligence on trial performance and data quality across all sites and home-based participants. Medidata’s patient-facing module, myMedidata Patient Cloud, is designed to “virtually recruit inclusive and diverse patients, keep them engaged throughout the trial, and produce better study results, ultimately enhancing the patient experience.” In practice, this means features like a single login for patients, an intuitive dashboard for all their trial tasks, and seamless data flow to investigators. It’s no surprise that Medidata is a dominant player – as of 2025, 19 of the top 20 pharma companies rely on Medidata’s platform, which has supported over 35,000 trials and 10 million patients to date. Sponsors value how an integrated platform simplifies trial management while maintaining regulatory compliance (e.g. 21 CFR Part 11 for all eClinical data) by design.

Other companies are also investing heavily to support sponsors with DCT capabilities. For instance, in 2024 Labcorp partnered with Hawthorne Effect – a provider of home nursing and telehealth technology – to offer in-home clinical trial visits and assessments. This collaboration was driven by sponsor demand to “increase patient diversity and inclusion, decrease site burden, and accelerate enrollment and study timelines.” By combining Labcorp’s global lab and logistics infrastructure with Hawthorne’s digital platform for conducting complex study visits at the patient’s home, the partnership demonstrated the power of DCT: it “increased diverse patient participation, improved the completeness and timeliness of trial data, and accelerated trial timelines.” For sponsors, it means trials can reach broader populations and finish faster, without compromising data quality – a clear competitive advantage.

Another notable player is THREAD, a DCT technology provider often cited as a leader in the space. THREAD offers a versatile platform and consulting services that enable “studies for everyone, everywhere.” In practice, THREAD’s cloud platform supports remote ePRO, sensors, eConsent, and site/patient communications in one solution. The company prides itself on making trials “accessible, efficient and centered on the patient.” It even introduced no-code tools (like a configurable single sign-on for sites and patients) to simplify the user experience and integration with sponsor system. This kind of patient-centric, flexible design is a hallmark of the new tech-driven CRO model. Indeed, THREAD has been recognized in industry assessments (e.g. Everest Group, IDC) as a leading DCT platform, indicating that sponsors have trustworthy options beyond the largest vendors.

Across all these examples, the common theme is integration and patient-centricity. A unified DCT platform not only makes life easier for sites and sponsors (with one login, one data repository, one set of SOPs), but also for patients – by coordinating scheduling, reminders, data collection, and even drug delivery to the home. The payoff for biopharma sponsors is substantial. Medable (another DCT platform provider) has noted that end-to-end digital trial platforms can reduce overall trial timelines by as much as 50% in some cases. Faster enrollment, higher retention, fewer protocol deviations, and real-time data all contribute to getting results sooner and at lower cost. By partnering with tech-enabled CROs or adopting robust DCT platforms, sponsors can execute decentralized trials with confidence that patient data will be high-quality and regulatory requirements met. The leading providers – whether it’s Medidata, THREAD, Labcorp, or others – are effectively serving as DCT enablers, giving sponsors the tools and support to run trials anywhere in the world.

 

Conclusion: Driving Better Trials Through Technology

From wearable sensors and telehealth visits to ePRO apps and integrated digital platforms, the innovations powering decentralized clinical trials are clearly delivering value. These technologies are making trials more patient-friendly and inclusive – boosting engagement by reducing travel burdens and enabling patients to participate on their terms. At the same time, they are elevating data quality and oversight by capturing more continuous, real-world data and automating processes that were once error-prone. The net effect is greater efficiency: streamlined operations, faster recruitment and enrollment, and improved retention translate to shorter trial timelines and potentially lower costs for sponsors. As one report put it, the benefits of DCTs – from “faster data collection” to “more diverse patient engagement” – present significant opportunities for innovation, allowing the industry to gather robust clinical evidence more efficiently and accelerate new treatments to market.

Crucially, these gains do not come at the expense of quality or compliance. Modern DCT solutions are built with regulatory requirements in mind (21 CFR Part 11-compliant data systems, GCP-trained telemedicine staff, auditable workflows, etc.), and regulators are increasingly comfortable with decentralized methods when proper controls are in place. In fact, sponsors who embrace DCT technologies may find that compliance is enhanced – for example, digital platforms can enforce protocol steps and flag deviations in real time, something not easily done in paper-based trials.

For United States (U.S.) sponsors and clinical operations leaders, the message is that decentralized trial technologies are no longer experimental – they are transformational tools ready to be deployed. Embracing wearables, telehealth, remote data capture, and unified platforms can lead to more patient-centric trials that not only delight participants (through easier access and engagement) but also deliver robust results faster. In an age where speed and diversity in clinical research are paramount, those sponsors who leverage these innovations will be well positioned to bring new therapies to patients more efficiently. The technology is here; the regulatory support is growing. Now it’s about operationalizing these capabilities to design smarter, more resilient trials. By doing so, sponsors can reduce trial friction, reach the right patients wherever they are, and ultimately improve the odds of trial success – a win for patients, sponsors, and healthcare progress alike.

About TFS HealthScience CRO

TFS HealthScience is a full-service, global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to advance innovative treatments and improve patient outcomes.  With operations across 50 countries, TFS and its strategic partners provide tailored strategic resourcing solutions and clinical development services in specialized therapeutic areas, including Dermatology, Oncology, Neuroscience, and more. At TFS, we believe that clinical trial success hinges on more than just experience; it requires innovation. As a tech-enabled CRO, we integrate advanced technologies across every function to drive smarter, faster, and more efficient trials. From data-driven clinical development decision-making to scalable FSP and strategic resourcing solutions, our approach is designed to meet the evolving needs of sponsors in a digital era.

 Explore our technology capabilities  or connect with a TFS representative  to learn how we can bring your next trial to life today!