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Decentralized Trials

Decentralized clinical trial software for controlled remote execution

Wemedoo supports decentralized and hybrid trials through a structured approach and unified clinical trial software ensuring remote execution remains controlled, traceable, and compliant.

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ISO 27001 SOC 2 FDA 21 CFR Part 11 GDPR & HIPAA

Unified Execution

Why decentralized clinical trials require unified execution

Decentralized clinical trials add complexity to remote data capture, patient engagement, and study oversight.

When these activities rely on multiple disconnected tools, data becomes fragmented, visibility decreases, and coordination across sites, vendors, and patients is harder to maintain.

A unified clinical trial software brings decentralized and site-based activities together in one environment, enabling consistent data flow, centralized oversight, and more controlled study execution.

Modular eClinical systems

Data spread across multiple remote systems and platforms

Limited visibility into patient activities and study progress

Separate tools for engagement, data capture, and monitoring

High coordination effort across sites and vendors

Unified Clinical Trial Software (oomnia)

All decentralized and on-site activities managed in one system

Continuous visibility across patient data and workflows

Integrated patient engagement and data capture

Streamlined operations with reduced complexity

Our Approach

Supporting decentralized and hybrid clinical trials with a unified clinical trial platform

Decentralized trials require clear structure and oversight to manage remote data, participants, and operations effectively

Flexible decentralized and hybrid trial models

Our approach supports a range of decentralized study designs, including:

Fully decentralized trials with remote participation
Hybrid trial designs combining on-site and remote activities
Site-less or reduced-site operational models

Digital patient engagement and remote data capture

Enabling effective patient participation across decentralized environments through:

Consistent data capture across remote and site-based activities
Clear data provenance and traceability
Continuous oversight and monitoring of trial progress

Reliable data and real-time trial oversight

Remote execution should not reduce visibility. Study workflows are designed to ensure:

Consistent data capture across remote and site-based activities
Clear data provenance and traceability
Continuous real-time oversight and monitoring of trial progress

Side by Side

Managing decentralized trials with modular vs unified systems

Area	Modular eClinical system	Unified clinical trial software (oomnia)
Data capture	Multiple tools for remote and site-based data collection	One system for real-time remote and on-site data capture
Visibility	Limited and delayed oversight across decentralized activities	Real-time visibility across all study workflows
Patient engagement	Separate platforms for patient interaction	Integrated patient engagement with real-time data capture
Data consistency	Inconsistent data across systems and sources	Consistent, real-time data across all study activities
Coordination	High effort to manage vendors and systems	Streamlined coordination within one environment
Compliance	Complex to maintain traceability across tools	Centralized control with real-time auditability and traceability
Operations	Fragmented workflows and manual processes	Structured workflows with reduced complexity and real-time oversight

Regulatory Readiness

Regulatory readiness for decentralized clinical trials

Decentralized trials must meet the same regulatory and compliance standards as traditional studies

Aligned with GxP principles

Supports GxP-aligned processes across all decentralized and remote clinical research operations

Supports compliance with 21 CFR Part 11

Fully compatible with 21 CFR Part 11 electronic records and signature requirements for remote environments

ICH-GCP-compliant workflows and oversight controls

Workflows structured in accordance with ICH-GCP standards, supporting oversight across distributed study sites

GDPR-aligned data handling and privacy safeguards

GDPR-compliant data handling and privacy protection across all remote and site-based study environments

Built-in audit trails and full data traceability

Automatic audit trails and complete data traceability across all decentralized study operations and remote activities

Validation documentation and continuous system compliance support

Clear validation documentation and ongoing support to maintain compliance across decentralized trial configurations

Who We Serve

Used across research and regulated industries

Wemedoo supports decentralized trials across a broad range of research and regulated organizations, addressing diverse operational and compliance needs

Large biopharma

Oversight of complex, global study portfolios

Emerging and mid-sized biopharma

Scalable and adaptable infrastructure to enable expanding clinical pipelines

MedTech companies

Accelerated study delivery with greater transparency into operations

CROs

Operational efficiency through consolidation of disconnected vendor platforms

Academic institutions

More efficient processes tailored for research teams with limited resources

Clinical trial units

Unified management of data and operations across multiple sites and departments

Food industry

Integrated coordination of safety, quality, and regulatory research across diverse product lines

Cosmetics

Organized frameworks for safety evaluation and product claims support across global markets

Animal health

Comprehensive, end-to-end support for veterinary research and product development

Nutraceuticals

Structured management of compliance and substantiation studies for nutraceutical offerings

Explore our clients

Trusted Partners

Decentralized trials supported through meaningful partnerships

Wemedoo collaborates with Research Professionals (RP-CRO) and Research Professionals |DCT| (Decentralized Clinical Trials) to support decentralized and hybrid clinical trials through a combined approach of unified software and operational expertise.

By connecting oomnia with CRO and DCT delivery capabilities, organizations can manage remote and site-based activities with greater coordination, consistent data flow, and controlled execution across the full study lifecycle.

Therapeutic Coverage

Built to support decentralized trials across therapeutic areas

oomnia supports decentralized and hybrid clinical trials across a wide range of therapeutic areas within a single unified platform.

By using one connected system for remote and site-based activities, teams can run Phase I through Phase IV studies across multiple therapeutic areas while maintaining consistent data standards, streamlined operations, and centralized oversight throughout the clinical lifecycle.

Explore how oomnia supports various therapeutic areas

Clinical Development Strategy

How decentralized trials connect to other clinical trial models

Decentralized clinical trials are often part of a broader clinical development strategy, working alongside traditional and hybrid study designs across different phases and data sources.

Explore Phase I–IV clinical trials Learn about real-world data studies

The Platform

A unified clinical trial software for decentralized trials

oomnia brings decentralized data capture, patient engagement, and trial operations together in one unified software environment, enabling consistent data management and oversight across distributed studies

EDC

EDC software

Unified Electronic Data Capture system for compliant, real-time clinical data collection

CTMS

CTMS software

Automated trial management solution designed to streamline study oversight

ETMF

eTMF software

Digital workspace for storing, managing, and accessing trial master file documents

ECONSENT

eConsent software

Electronic informed consent solution designed for seamless participant consent capture

EPRO

ePRO software

Real-time electronic patient-reported outcomes solution for patient data entry

ECOA

eCOA software

Capture patient-reported outcomes, clinician assessments, and study data in real time without paper workflows

RTSM

RTSM software

Randomization and Trial Supply Management system that automates treatment allocation and blinding in real-time

ESOURCE

eSource clinical trials

Electronic source system that captures original site data in real time, fully validated and without manual transcription

Unified approach with oomnia

Get Started

Bringing decentralized trials together in one environment

From fully remote to hybrid models, trial setup is aligned with your operational workflows, data pathways, and regulatory needs

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Frequently asked questions (FAQ)

What is a decentralized clinical trial?

A decentralized clinical trial (DCT) enables participants to take part in some or all study activities remotely, using digital technologies such as eConsent, ePRO, eCOA, and remote data capture. Depending on the design, site visits may be reduced or replaced with virtual interactions, home visits, or digital workflows.

How does Wemedoo support decentralized and hybrid trials?

Wemedoo enables decentralized and hybrid trials through a unified software environment that brings trial operations, data capture, and oversight together. The structured approach ensures that remote execution remains controlled, traceable, and compliant with regulatory requirements.

Can decentralized trials still maintain strong oversight and visibility?

Yes. Remote participation does not mean reduced control. Study workflows are designed to provide continuous visibility into trial progress, with consistent data capture, clear audit trails, and real-time oversight across both remote and site-based activities.

What types of decentralized trial models are supported?

Wemedoo supports a range of models, including fully decentralized trials, hybrid trials combining on-site and remote elements, reduced-site or site-less designs, and digitally enabled patient engagement and data collection.

How is data quality ensured in decentralized trials?

Data quality is maintained through standardized workflows, consistent data collection across all study activities, and clear data provenance. Centralized systems help ensure traceability, version control, and alignment between operational and clinical data.

Are decentralized trials compliant with regulatory requirements?

Decentralized trials must meet the same regulatory and compliance standards as traditional trials. Processes are designed to support audit readiness, alignment with applicable regulatory guidance, and data protection and privacy requirements across regions.

Which organizations typically use decentralized trial approaches?

Decentralized trials are used across a broad range of regulated and research settings, including biopharma companies of all sizes, MedTech organizations, CROs, academic institutions, clinical trial units, and industries such as food, cosmetics, animal health, and nutraceuticals.

What tools are included to support decentralized trials?

Decentralized trials are supported through a unified set of tools within oomnia, including EDC, CTMS, eTMF, ePRO, eSource, eCOA, eConsent, and RTSM. All tools operate within one integrated environment to reduce fragmentation and complexity.

Can decentralized workflows be aligned with existing trial operations?

Yes. Trial setup is tailored to existing operational workflows, data pathways, and regulatory needs. This ensures that decentralized or hybrid execution integrates smoothly with established processes rather than disrupting them.

Is oomnia suitable for both fully remote and hybrid studies?

Absolutely. oomnia is designed to support the full spectrum of decentralized trial models, from fully remote studies to hybrid designs, while maintaining consistent data management, oversight, and regulatory readiness across all study types.