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Real-World Data Trials

Clinical trial software for real-world and observational studies

Wemedoo supports real-world and observational studies through unified clinical trial software and professional services, ensuring data quality, traceability, and operational control from start to finish.

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

Unified Approach

Why managing real-world data studies in one system matters

Real-world data programs span multiple study types, data sources, and timelines, often requiring teams to switch between systems as evidence generation evolves.

This fragmented approach leads to disconnected datasets, duplicated integration efforts, and limited visibility across the full real-world evidence lifecycle.

A unified platform like oomnia, built as a Clinical Research Information System (CRIS), enables consistent management of real-world data studies, ensuring continuity across data sources, workflows, and regulatory requirements.

Modular eClinical systems

Multiple systems used across real-world data sources and study types

Disconnected datasets from clinical, registry, and real-world sources

Repeated integration and configuration efforts

Limited visibility across the full evidence generation lifecycle

Unified Clinical Trial Software (oomnia)

One platform supporting real-world data and clinical research workflows

Continuous data consistency across all sources and studies

Reusable data models and integration frameworks

Full traceability from data capture to real-world evidence generation

Our Approach

Supporting real-world and observational studies

Real-world studies require flexible workflows, structured oversight, and reliable data management across diverse research environments

Observational and non-interventional studies

Support for observational and non-interventional studies with structured workflows, continuous oversight, and consistent data collection across study activities

Registry-based and longitudinal research

Enable registry-based and long-term follow-up studies with clear traceability, structured data management, and ongoing evidence collection over extended timelines

Hybrid and digital studies

Support hybrid and digitally enabled study designs combining remote participation, real-world data collection, and centralized operational oversight

Side by Side

Managing real-world data studies with modular eClinical systems vs a unified approach

Area	Modular eClinical system	Unified clinical trial software (oomnia)
Systems	Multiple systems across data sources and study types	One platform across all real-world data workflows
Data consistency	Disconnected datasets across sources and studies	Continuous data consistency across all data streams
Data integration & setup	Repeated integration and configuration per study or source	Reusable data models and standardized integration frameworks
Traceability	Limited visibility across data sources and transformations	Full traceability from data capture to evidence generation
Operational risk	Increased risk across handovers and integrations	Reduced risk with a unified, controlled environment
Efficiency	Manual reconciliation and delays between datasets	Faster insights with streamlined, connected workflows

Regulatory Readiness

Built for regulated research environments

oomnia is designed to meet global regulatory expectations through structured controls and validated processes

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

Our work supports a broad range of organizations, each with distinct operational, regulatory, and study requirements

Large biopharma

Oversight of complex, global study portfolios

Emerging and mid-sized biopharma

Flexible infrastructure to support growing clinical programs

MedTech companies

Faster study execution with improved operational visibility

CROs

Simplifying operations by replacing fragmented vendor systems

Academic institutions

Streamlined workflows for resource-constrained research teams

Clinical trial units

Centralized data and operations across sites and departments

Food industry

Coordinated safety, quality, and regulatory studies across product ranges

Cosmetics

Structured support for safety assessment and product substantiation across markets

Animal health

End-to-end support for veterinary studies and product development

Nutraceuticals

Managing substantiation and compliance studies for nutraceutical products

Explore our clients

Trusted partners

Global network of partners

Clinical Development Strategy

How real-world studies connect to other clinical trial models

Real-world studies are often integrated with broader clinical development strategies, supporting evidence generation before, during, and after traditional clinical trials.

Explore Phase I–IV clinical trials Explore decentralized clinical trials

Essential tools unified in one platform

A unified clinical trial software for real-world data studies

oomnia brings real-world data, observational research, and clinical trial operations together in one unified software environment, enabling consistent data management, oversight, and traceability

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

Build structured and reliable real-world studies

Connect observational data, oversight, and evidence generation within one controlled environment.

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Frequently asked questions (FAQ)

What is a real-world data (RWD) trial?

A real-world data trial uses data collected outside traditional randomized clinical trials, such as routine clinical practice, registries, or digital sources, to generate evidence on treatment use, outcomes, and safety.

What types of real-world studies are supported?

Support is provided for observational and non-interventional studies, registry-based research, hybrid and digitally enabled designs, and post-market or outcomes-focused evidence generation.

How do you ensure data quality in real-world studies?

Study workflows are designed to ensure data structure, consistency, and early validation, with clear traceability, ongoing review, and defined oversight processes throughout the study lifecycle.

Can real-world data be combined with clinical trial data?

Yes. Real-world data elements can be incorporated alongside traditional clinical trial data, enabling broader context, long-term follow-up, and post-approval evidence generation when appropriate.

How are regulatory and compliance requirements addressed?

Real-world data studies are set up with clear data provenance, documentation, and controls to support alignment with applicable regulatory, data protection, and inspection requirements.

What is the Across Global Alliance, and how does it fit in?

Wemedoo is a member of the Across Global Alliance, which provides access to a global network of experienced clinical data professionals to support tailored real-world data collection.

Which organizations use real-world data trial approaches?

Real-world data studies are used across large and emerging biopharma, MedTech companies, CROs, academic institutions, clinical trial units, and regulated industries such as food, cosmetics, animal health, and nutraceuticals.

What tools are used in real-world data trials?

Real-world data studies can leverage essential clinical trial tools such as EDC, CTMS, eTMF, ePRO, eSource, eCOA, eConsent, and RTSM, unified within a single software environment.

How is implementation handled for real-world data studies?

The implementation approach is adapted to your data sources, study goals, and regulatory context, ensuring a practical setup that fits the specifics of each real-world study.

How can we get started with a real-world data study?

The best next step is to speak with the team to discuss your study objectives, data sources, and requirements, and define a suitable approach.