Decentralized Clinical Trials, Executed End-to-End

From eConsent to remote endpoints, we run decentralized, hybrid, and site-augmented studies that enroll faster, retain better, and deliver evidence sponsors can publish.

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[TRUST BAR: decentralized trials executed | participants enrolled remotely | peer-reviewed publications | tech partner and client logos]

What Are Decentralized Clinical Trials?

Decentralized clinical trials (DCTs) are studies that conduct some or all of their activities remotely, using technology like telemedicine, eConsent, wearables, and direct-to-patient drug supply to reach participants where they are. DCTs reduce site burden, broaden patient diversity, and often accelerate enrollment compared to traditional site-based studies.

DCT isn't a single methodology; it's a spectrum. Some studies are fully decentralized: every visit happens at home, every endpoint is captured remotely. Others are hybrid: a mix of on-site and remote visits. Others are site-augmented: traditional sites with technology like ePRO and wearables added in. The right model depends on your protocol, your therapeutic area, and your patient population.

The DCT Spectrum:

Traditional: all activities at the clinical site
Site-augmented: site-based with ePRO, wearables, and remote monitoring layered in
Hybrid: mix of on-site visits and remote/home visits
Fully decentralized: all activities remote, no traditional site

People Science designs studies across the full spectrum. Most of our published work is fully decentralized; we also run hybrid and site-augmented protocols where the science calls for it.

[VISUAL: DCT spectrum graphic]

Why Sponsors Choose Decentralized Clinical Trials

Faster Enrollment

Without geographic constraints, DCTs draw from broader populations and complete enrollment in less time. Most of our DCT programs see enrollment timelines compressed by 30 to 50% versus traditional designs.

Better Retention

Reducing the burden of in-person visits keeps participants engaged. We routinely see DCT retention rates above 85%, well ahead of industry averages for site-based studies.

Broader Patient Diversity

Geography, transportation, and time off work are real barriers to traditional trial participation. DCT models open the door to participants who couldn't otherwise reach a study site, supporting compliance with FDA's Diversity Action Plan requirements.

Lower Cost Per Enrolled Patient

Fewer site visits, less travel reimbursement, lower drop-out rates. The economics of DCT often beat traditional designs.

Real-World Data Capture

Wearables, ePRO, and connected devices capture data in the participant's actual environment, not a clinic. More representative outcomes that translate to real-world use.

The Decentralized Trial Toolkit

DCT is the integration of these components, designed around the participant's experience.

eConsent. Participants understand and sign consent on their own device, with multimedia explanations and comprehension checks built in.

Telemedicine and Telehealth Visits. Investigator-led visits via secure video, with structured assessments captured in real time.

ePRO and eCOA. Participant-reported outcomes captured digitally, often through a study app, with automated reminders and data validation.

Wearables and Connected Devices. Continuous, passive data capture: heart rate, sleep, activity, glucose, blood pressure.

Direct-to-Patient Drug Supply. Investigational product shipped to the participant's home with chain-of-custody and temperature controls.

Mobile Nursing and Home Health Visits. In-home phlebotomy, dosing, infusions, and clinical assessments where remote tools alone aren't enough.

Remote Monitoring and Site Oversight. Real-time data quality monitoring, AE detection, and site oversight without travel.

Decentralized Site Networks. Distributed sites that complement remote activities for hybrid models.

Why Sponsors Choose People Science for DCT

DCT-Native, Not DCT-Adjacent

Most CROs added DCT capability over the last few years. We've been running decentralized studies since the start, and our published evidence reflects that. [STAT NEEDED: percent of completed studies that are fully or hybrid decentralized]

Peer-Reviewed Evidence

Our DCT methodology has been validated in peer-reviewed publications, including studies in Nature Scientific Reports. Sponsors get a methodology that's been external-vetted, not just internally claimed.

Integrated Platform

Our Chloe Clinical platform unifies eConsent, ePRO, study management, and participant communications in one integrated system. Less vendor coordination, faster activation, cleaner data. [STAT NEEDED: average study activation time using Chloe Clinical]

Patient-First Methodology

Every protocol is designed around the participant experience first, the operational convenience second.

Where Decentralized Clinical Trials Work Best

DCT is a stronger fit in some therapeutic areas than others. Categories where we've delivered strong DCT outcomes:

Metabolic health and weight management
Sleep and cognitive health
Mental wellness, anxiety, and stress
Digestive health and microbiome
Pediatric nutrition and synbiotic
Women's health
Dermatology and cosmetics
Cannabinoid and emerging categories
Functional foods, beverages, and dietary supplements

From Feasibility to Final Report

Step 1: Feasibility and DCT Design Consult. We start with the question your protocol needs to answer, then map the right DCT components to it.

Step 2: Tech Stack and Vendor Selection. Chloe Clinical for core operations; complementary tech partners (wearables, telehealth, drug supply) integrated where needed.

Step 3: Protocol, IRB, and Regulatory Strategy. Protocol design with FDA DCT guidance and ICH GCP E6(R3) baked in.

Step 4: Recruitment and Activation. Targeted recruitment leveraging our remote-first network. Diversity built into screening criteria.

Step 5: Patient-Centered Execution. eConsent, telehealth visits, ePRO, wearables, direct-to-patient logistics, mobile nursing where needed.

Step 6: Data Integration, Analysis, and Reporting. Integrated data from every source. Statistical analysis, regulatory-ready report, and publication support.

DCT, Done Right Under FDA and ICH

DCT is regulated. The FDA's 2023 final guidance on decentralized clinical trials, ICH GCP E6(R3), 21 CFR Part 11, and FDA's Diversity Action Plan requirements all shape how a DCT must be designed and executed.

People Science designs every study with these in mind: data integrity, audit trail, eSource validation, participant safety in remote contexts, informed consent comprehension, and demographic representation. Our protocols and reports are built to support sponsors through any regulatory submission.

DCT Studies That Made the Literature

Mimio: Recreating Fasting Benefits with a Novel Fasting Mimetic

Double-blind, placebo-controlled, randomized, decentralized trial. Published in Nature Scientific Reports.

Persephone: Chloe Clinical Software Enables Novel Infant Synbiotic Study

Double-blind, placebo-controlled, randomized, decentralized trial. Demonstrated DCT execution in a pediatric population.

Verb Biotics: Evaluating a Novel GABA Probiotic's Impact on Sleep Quality

Double-blind, placebo-controlled, randomized, decentralized trial. Published in Nature Scientific Reports.

[CALLOUT: Two peer-reviewed publications in Nature Scientific Reports]

Built on Chloe Clinical, Integrated With the Best

Our Chloe Clinical platform anchors every study: eConsent, ePRO, study management, and participant communications, all in one system. We integrate complementary tech where it adds value, including wearable data platforms, telehealth providers, and direct-to-patient logistics partners.

We're platform-pragmatic, not platform-dogmatic. Sponsors who arrive with a preferred tech stack are welcome; sponsors who want us to assemble the stack get a battle-tested default.

Senior Scientists. DCT Operators. Real Practitioners.

Our team brings decades of combined experience across clinical research, decentralized methodology, biostatistics, regulatory affairs, and consumer product development. PhDs, MDs, RDs, biostatisticians, and DCT-native operators sit on every project.

When you call us, you talk to the scientist who designed your study, not a layer of account management.

Frequently Asked Questions

What are decentralized clinical trials? DCTs are studies that conduct some or all activities remotely, using technology like telemedicine, eConsent, wearables, and direct-to-patient drug supply. Compared to traditional site-based trials, DCTs reduce participant burden, broaden diversity, and often accelerate enrollment.

What is the difference between a decentralized and a hybrid clinical trial? A fully decentralized trial conducts every activity remotely. A hybrid trial mixes remote and on-site visits. Site-augmented trials are traditional site-based studies with DCT components like ePRO and wearables. The right model depends on the protocol and patient population.

Are decentralized clinical trials FDA-approved? Yes. The FDA published final guidance on DCTs in 2023, formally endorsing the modality. ICH GCP E6(R3), finalized in 2024, also incorporates DCT considerations into the global GCP standard.

What are the benefits of decentralized clinical trials? Faster enrollment, higher retention, broader patient diversity, lower cost per enrolled patient, and richer real-world data. DCTs also reduce burden on study sites and on participants.

How do you ensure patient safety in a decentralized trial? Through redundant safety monitoring: continuous wearable data review, ePRO-based AE prompts, telehealth check-ins, mobile nursing for in-person assessments when needed, and 24/7 participant support.

What technology is used in decentralized clinical trials? eConsent, telemedicine, ePRO/eCOA tools, wearables, direct-to-patient logistics, and integrated study management systems. People Science uses our Chloe Clinical platform for core operations.

What therapeutic areas are best suited for DCTs? Metabolic health, sleep, mental wellness, digestive health, women's health, dermatology, dietary supplements, and many functional product categories. Also viable in pediatric and emerging-category research.

Can a DCT meet FDA Diversity Action Plan requirements? Yes, and DCT is often a stronger path. Removing geographic and logistical barriers expands access to participants who couldn't otherwise reach a study site.

How long does it take to activate a DCT study? With Chloe Clinical and our DCT-native operations, most studies activate in weeks rather than months. Exact timeline depends on protocol complexity and recruitment plan.

Will a DCT cost more or less than a traditional trial? DCT often comes in lower cost-per-enrolled-patient because of faster enrollment and higher retention. Up-front technology costs can be higher; downstream operational costs are typically lower.

Keep Reading

DCT Feasibility Checklist (downloadable PDF)
Hybrid vs. Fully Decentralized: Which Model Fits Your Study?
Clinical Research Organization Services [links to Page 1]
Structure Function Claim Substantiation [links to Page 2]

Ready to Run a Decentralized Trial That Holds Up?

Free 30-minute DCT feasibility consult for your protocol. Bring the question, the population, the timeline. We'll bring the methodology.