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TrialKit Decentralized Clinical Trial Platform

Execute studies 30% faster with a truly SaaS solution for decentralized clinical trials.

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What are Decentralized Clinical Trials?

Decentralized clinical trials (DCTs) are studies that use digital technologies to enable patients to participate without needing to visit a physical clinical site. Data is collected remotely through mobile apps, wearable devices, eConsent, electronic patient-reported outcomes (ePRO), and telehealth solutions.

Unlike traditional trials, which require frequent on-site visits, decentralized trials give participants more flexibility, whether they’re completing assessments at home, joining virtual visits, or submitting data through a smartphone. This approach reduces barriers to participation and expands access to more diverse patient populations.

Learn more about the evolution of decentralized trials.

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What are Hybrid Trials?

Hybrid clinical trials combine elements of both traditional and decentralized approaches. While some visits are conducted on-site (such as blood draws or imaging procedures), others—like patient questionnaires or follow-up consultations—occur remotely.

Hybrid trials are ideal when studies require occasional in-person assessments but still aim to reduce site burden, expand access, and offer a more patient-centric experience.

Challenges in Decentralized and Hybrid Trials

While decentralized and hybrid clinical trials offer significant advantages, they also introduce new operational complexities:

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Technology access and digital literacy

Not all patients or sites are equally equipped to use mobile apps, wearables, or telehealth tools.

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Data security and privacy concerns

Remote access increases the risk of data breaches without proper controls.

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Regulatory variability across regions

Standards may differ depending on geography, requiring adaptable compliance strategies.

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Device and platform fragmentation

Managing multiple data sources (wearables, eConsent tools, virtual visit platforms) can create silos if not integrated.

TrialKit is designed to overcome these barriers by providing a unified platform that:

  • Enables scalable deployment across global sites and participant populations
  • Centralizes all trial activity: EDC, ePRO, eConsent, imaging, and virtual visits
  • Offers intuitive mobile and web interfaces to minimize the learning curve
  • Supports HIPAA, GDPR, and 21 CFR Part 11 compliance with built-in controls

The Role of Technology in Decentralized and Hybrid Clinical Trials

To successfully run decentralized or hybrid clinical trials, sponsors and CROs need interoperable, regulatory-compliant technology. TrialKit offers an end-to-end digital infrastructure that supports every phase of a decentralized study:

– EDC: Capture validated data remotely in real time with full audit trails and source tracking.
– eCOA/ePRO: Empower patients to self-report symptoms and outcomes from any device.
– eConsent: Obtain informed consent remotely with identity verification and real-time updates.
– Virtual visits: Conduct televisits and remote assessments within a secure, fully integrated platform.

All modules are natively accessible via iOS, Android, web, and Mac, ensuring that both participants and study teams can engage from any location without switching platforms.

Benefits of Decentralized Clinical Trials

Streamlined Clinical Trial Workflows

Reduced Site Burden

  • Lower administrative load by replacing paper forms and manual tracking
  • Minimize on-site monitoring through automated alerts and remote access
  • Enable virtual visits with no additional infrastructure
  • Learn how TrialKit supports remote data collection

Improved Regulatory Compliance

TrialKit: Your Ultimate Decentralized Trial Solution

TrialKit is a unified eClinical platform built to support modern research—whether you’re conducting a fully decentralized trial, a hybrid study, or a traditional design that needs more flexibility. It includes:


– Electronic Data Capture (EDC)
– ePRO and eCOA
– eConsent
– Televisits and remote assessments
– Imaging (PACS), adjudication, and AI-powered reporting
– Wearable integrations and real-world data capture

With TrialKit, you can scale your DCTs without adding operational burden or sacrificing data quality.

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  • We rely on TrialKit to document the collection of dried blood samples and upload data from users’ mobile devices to secure storage in the cloud. Collaborating with the experienced TrialKit team has been a very cost-effective method to rapidly design and test a capable and polished product.

    CEO
    Read the full case study

FAQs About Decentralized Trial Solutions

What types of trials are best suited for decentralization?

Decentralized clinical trials are ideal for studies that don’t require frequent on-site procedures, including observational research, post-marketing surveillance, and Phase II–III trials where remote data collection is feasible.

Can decentralized trials fully replace traditional studies?

Not always. Some trials still require in-person assessments or highly controlled environments. However, hybrid trials—which blend remote and in-person components—offer a flexible path forward and are becoming increasingly common.

How does TrialKit ensure data security and compliance?

TrialKit supports global regulatory standards, including 21 CFR Part 11, HIPAA, and GDPR. Features include encrypted data transmission, multi-factor authentication, audit trails, and role-based access.

Can an EDC system be used in decentralized or hybrid trials?

Absolutely. EDC systems are especially valuable in decentralized and hybrid trials because they allow data to be collected remotely via mobile devices, wearable tech, or home visits, supporting patient engagement and real-time data access.

What is the difference between decentralized and hybrid clinical trials?

Decentralized trials eliminate the need for regular site visits by leveraging digital tools. Hybrid trials combine remote data collection with in-person touchpoints for assessments that must be conducted on-site.

How can EDC benefit decentralized clinical trials?

EDC software for decentralized clinical trials enables remote data collection, real-time monitoring, and automated data validation—all of which support faster decisions, reduced errors, and improved patient experience.