REAL-TIME ESOURCE SOFTWARE FOR CLINICAL TRIALS
eSource clinical trials solution
oomnia eSource is part of Wemedoo's unified clinical trial software, enabling structured source documentation within a clinical research information system (CRIS).
Unified data capture
What is oomnia eSource software?
oomnia eSource is an electronic source system that captures original site data in real time, fully validated and without manual transcription, replacing paper source records and eliminating secondary entry into eCRFs.
Operating within a unified clinical research information system, source documentation is structured from the moment of entry and remains traceable throughout the study lifecycle.
CLINICAL DATA
What is oomnia eSource used for?
oomnia eSource captures original site data directly at the point of care — eliminating paper source documents, manual transcription, and the need for SDV visits.
oomnia eSource supports:
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Digital capture of original source records
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Automated transfer of structured data to EDC
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Elimination of duplicate transcription steps
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Reduced Source Data Verification (SDV) workload
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Remote monitoring access to validated source data
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Integration with EHR, HIS, and LIMS systems
By eliminating paper workflows and manual transcription steps, organizations can reduce documentation effort by up to 80%.
*Based on internal process optimization assessments and client-reported efficiency gains
Key Capabilities
Key capabilities of oomnia eSource software
| Aspect | Modular eClinical systems | Unified clinical trial software (oomnia) |
|---|---|---|
| Data capture at source | Paper worksheets or hybrid entry followed by later transcription into EDC | Direct electronic capture at the point of care within a unified clinical system |
| Transcription & duplication | Manual re-entry into eCRFs required | No duplicate entry, structured data flows directly into the study database |
| Data reconciliation | Manual comparison between source and EDC | No cross-system reconciliation required |
| Data model structure | Unstructured notes or site-specific formats | Structured, protocol-aligned data model shared across CRIS modules |
| Validation at entry | Post-entry review and correction | Source-level validation rules applied at the moment of data capture |
| Monitoring model | On-site SDV dependent | Remote-accessible, real-time source review with reduced SDV burden |
| Audit & traceability | Manual logs or limited traceability | Full electronic audit trail from initial capture through study lifecycle |
| EDC integration | Secondary data transfer required | Immediate structured mapping to eCRFs within the unified environment |
| EHR / HIS interoperability | Manual uploads or disconnected exports | HL7 / FHIR-based integration for structured healthcare data transfer |
| LIMS integration | Lab reconciliation performed separately | Structured LIMS-to-eSource data transfer within unified model |
| Scalability & data volume | Physical storage limitations and fragmented digital archives | Enterprise-grade storage, processing, and structured retrieval capabilities |
| Offline capability | Paper fallback processes | Secure offline capture with controlled synchronization |
| Reporting & analytics | Manual aggregation for reporting | Real-time dashboards, exports, and analytics-ready structured data |
| Inspection readiness | Time-intensive preparation and verification | Inspection-ready documentation supported by unified compliance framework |
Regulatory Readiness
Compliance and validation
oomnia eSource supports regulatory requirements relevant to electronic source documentation:
GxP principles
GxP-aligned processes ensuring compliance across all clinical operations
21 CFR Part 11
Compliant electronic records and secure electronic signatures
ICH-GCP
Workflows aligned with ICH-GCP standards and regulatory expectations
ALCOA+ data integrity
Data is attributable, legible, contemporaneous, original, accurate, and complete
FAIR data principles
Data is findable, accessible, interoperable, and reusable
Validation & audit readiness
Source-level validation rules, full audit trails, and inspection-ready documentation
How It Works
How oomnia eSource works inside a unified clinical trial software?
When electronic source documentation operates within a unified Clinical Research Information System (CRIS), original site data remains within a single environment throughout the study lifecycle. This eliminates the need for data export, re-entry, or secondary validation across disconnected systems.
No data export or re-entry required across separate systems
Eliminates secondary validation and reduces duplication
Source data remains directly connected to study data and workflows
Seamless flow from capture to monitoring and reporting
Reduced dependency on manual reconciliation and data cleaning
Who This Is For
Who oomnia eSource software is for?
oomnia eSource is built for:
Sponsors replacing paper-based source documentation
CROs implementing remote and risk-based monitoring
Study teams reducing Source Data Verification (SDV) workload
Organizations integrating trials with hospital and device systems
The Platform
All clinical trial tools unified in one clinical trial platform
EDC software
Unified Electronic Data Capture system for compliant, real-time clinical data collection
CTMSCTMS software
Automated trial management solution designed to streamline study oversight
ETMFeTMF software
Digital workspace for storing, managing, and accessing trial master file documents
ECONSENTeConsent software
Electronic informed consent solution designed for seamless participant consent capture
EPROePRO software
Real-time electronic patient-reported outcomes solution for patient data entry
ECOAeCOA software
Capture patient-reported outcomes, clinician assessments, and study data in real time without paper workflows
RTSMRTSM software
Randomization and Trial Supply Management system that automates treatment allocation and blinding in real-time
Get Started
Ready to replace paper-based source documentation?
Transition from manual transcription to real-time, validated source capture within a unified clinical environment.
Book a demoFrequently asked questions
What is eSource in clinical trials?
eSource in clinical trials refers to the direct electronic capture of source data at the point of care, eliminating the need for paper source documents. Wemedoo's oomnia eSource solution allows investigators to enter data directly into electronic forms that serve as both the source document and the eCRF.
How does eSource eliminate paper in clinical trials?
oomnia eSource replaces paper-based source documents by enabling direct data capture into electronic forms aligned to the study protocol. Data entered at the site becomes the original source record, removing the need for transcription from paper to EDC, reducing errors, and accelerating data availability.
What are the benefits of eSource data capture?
eSource data capture provides immediate data availability for real-time monitoring, eliminates transcription errors, reduces site workload, enables remote source data verification, accelerates database lock timelines, and lowers operational costs by removing paper-based workflows.
Is eSource compliant with FDA and EMA requirements?
Yes, oomnia eSource is designed to comply with FDA guidance on electronic source data, EMA requirements, ICH GCP E6(R2), and 21 CFR Part 11. The system maintains complete audit trails, electronic signatures, and data integrity controls required for regulatory inspections.
How does oomnia eSource integrate with EDC?
oomnia eSource is fully integrated with the EDC module within one unified system. Data captured at the source flows directly into the clinical database without any manual data entry or reconciliation, providing investigators and monitors with real-time access to clean, validated data.