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Why Decentralized Trials Are Gaining Momentum

Decentralized Clinical Trails (DCT) shift key components of the clinical trial away from traditional sites and toward remote, patient-centered interactions. This shift is driven by:

  • Patient convenience and improved recruitment from underserved regions

  • Faster data capture via digital tools and wearables

  • COVID-19-era adaptations that have proven scalable

  • Regulatory openness to digital endpoints and remote assessments

But success depends on having the right systems, standards, and integrations in place—something many sponsors still struggle to navigate.


Decentralized Clinical Trials data sources image by Touchcore Systems

Key Systems Enabling DCTs


A decentralized or hybrid trial model relies on a connected ecosystem of tools, including:

  1. eConsent Platforms: Allow participants to remotely review and sign consent forms, with built-in comprehension checks.

  2. ePRO / eCOA: Enable patients to report outcomes from home, often via mobile apps or BYOD devices.

  3. Wearables & Sensors: Track vital signs, physical activity, or biomarkers in real time—feeding directly into the study database.

  4. Telemedicine Modules: Facilitate remote visits between investigators and participants, while capturing source data securely.

  5. Home Health Coordination: Manages logistics for in-home visits, sample collection, or medication delivery.

  6. Centralized EDC + Integration Hub: A centralized data platform (like Medidata Rave or Veeva Vault EDC) must be integrated with all remote tools to maintain data integrity and regulatory compliance.


Standards That Matter

Interoperability and compliance are crucial in decentralized models. Touchcore ensures alignment with:

  • CDISC/CDASH: For standardized data models across remote and site-based inputs

  • HL7/FHIR: For integration with EHR systems or digital health data

  • 21 CFR Part 11: Ensures electronic records and signatures are audit-ready

  • ICH GCP (E6/R2): Maintains clinical and regulatory rigor

By building around these standards, we ensure your tech ecosystem supports quality data, smooth submissions, and downstream analytics.


How Touchcore Systems Supports Decentralized Trials

We help sponsors and CROs plan, build, and integrate decentralized capabilities that fit their trial’s scope. Our services include:


✅ Modular Architecture for Rapid Deployment

We build or configure modules—such as remote visit scheduling, ePRO dashboards, or data ingestion layers—that plug into your EDC or CTMS environment.


✅ Medidata CRF + DCT Extension Support

As a team experienced with Medidata CRF development, we ensure your eCRFs are DCT-ready, supporting fields for telehealth encounters, remote monitoring, and device feeds.


✅ Custom Integrations with Wearables and eCOA Tools

We enable seamless data flow between third-party vendors and your central platform, eliminating manual reconciliation and reducing data lag.


✅ Study-Specific Dashboards

Touchcore builds dashboards that consolidate ePRO, lab, and wearable inputs, giving study teams real-time insights across geographies and data sources.


✅ Protocol-Aligned Digital Workflows

We don’t just digitize forms—we design protocol-specific workflows that support participant-centric engagement while maintaining regulatory fidelity.


Success Factors for DCT Execution

From our experience, successful decentralized or hybrid studies share these attributes:

  1. System Interoperability: All tools must talk to each other through secure, validated channels.

  2. User-Centered Design: Remote interfaces for patients and CRCs must be intuitive and accessible.

  3. Proactive Compliance Planning: Audit trails, version control, and documentation must be built in from day one.

  4. Agile Study Management: Teams must be trained to respond to tech issues, participant concerns, or data discrepancies in real time.

  5. Data Unification: The ability to harmonize site-based and remote data is essential for smooth interim analyses and submission readiness.


Final Thoughts

Decentralized trials unlock powerful benefits—but only when backed by purpose-built infrastructure. At Touchcore Systems, we support sponsors across therapeutic areas and trial phases to build the modular, standards-compliant ecosystems that make hybrid and fully remote trials successful.


Want to design your DCT stack—fit for science, patients, and speed, contact us at partner@touchcoresystems.com today.

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