PATIENT-CENTRIC ECOA SOFTWARE FOR CLINICAL TRIALS
eCOA software for clinical trials
oomnia eCOA is part of Wemedoo's unified Clinical Research Information System (CRIS), enabling electronic clinical outcome assessment across patients, caregivers, and clinicians within a single clinical research system. Capture patient-reported outcomes, clinician assessments, biomarker data, and continuous monitoring data in real time, without paper workflows or fragmented systems.
Unified data capture
Electronic clinical outcome assessment (eCOA) software
oomnia eCOA software enables electronic outcome assessments in clinical trials directly from patients, caregivers, and investigators using mobile devices, tablets, or web interfaces.
Instead of paper questionnaires and delayed data entry, outcome data, including structured questionnaires, free-text inputs, and time-series data from wearables, is captured in real time and immediately unified with the clinical trial database.
Operating inside a unified clinical research information system, all outcome data becomes structured, validated, standardized and aligned with Clinical Data Acquisition Standards Harmonization/ Study Data Tabulation Model (CDASH/SDTM) standards, and instantly available for monitoring, advanced analytics, and reporting.
CLINICAL DATA
What is oomnia eCOA software used for?
oomnia eCOA software improves outcome collection by enabling direct digital reporting and automated data validation at the moment of entry.
oomnia eCOA supports:
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Electronic Patient-Reported Outcomes (ePRO)
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Clinician-Reported Outcomes (ClinRO)
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Observer-Reported Outcomes (ObsRO)
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Performance Outcomes (PerfO)
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Caregiver-reported assessments
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Digital questionnaires and symptom diaries
By replacing paper outcome assessments, clinical trial teams gain faster insight into patient status while reducing administrative workload and missing data.
Key Capabilities
Key capabilities of oomnia eCOA software
| Aspect | Paper-based outcome collection | Modular eClinical system | Unified clinical trial software (oomnia) |
|---|---|---|---|
| Outcome data collection | Paper questionnaires completed at site visits | Digital forms captured in standalone systems | Digital outcome capture directly from patients, caregivers, or clinicians within a unified system |
| Data availability | Available after manual entry into EDC | Available after system sync or transfer | Outcome data available in near real time within the study database |
| Patient reporting | Limited to site visits | Remote reporting via separate eCOA tools | Continuous remote reporting via mobile, tablet, or web within one platform |
| Transcription workload | Manual transcription from paper to EDC | Reduced but still requires data transfer or mapping | No secondary transcription — data captured once and used across the system |
| Missing data management | Missing data identified late | Basic reminders in separate systems | Automated reminders and validation rules improve completeness in real time |
| Patient device access | Paper or site-provided devices | Provisioned devices or limited BYOD | Full BYOD support and multi-device access |
| Data validation | Post-entry review | Validation within the eCOA tool only | Validation aligned across the unified data model |
| Study monitoring | Delayed visibility | Partial visibility across systems | Real-time dashboards with complete study visibility |
| Data integration | Manual reconciliation between paper and EDC | Integration required between eCOA and EDC | No integration needed — shared data model across the system |
| Audit trails | Paper logs or limited traceability | Separate audit trails per system | One unified audit trail across all study data |
| Compliance | High risk of inconsistency | Compliance managed per system | Centralized compliance framework across the platform |
| Operational complexity | High manual workload | Reduced but still fragmented workflows | Reduced operational effort with unified workflows |
Regulatory Readiness
Compliance and regulatory readiness
oomnia eCOA software supports regulatory requirements relevant to electronic outcome collection in clinical trials. Electronic signatures, controlled user access, and complete audit trails ensure outcome data remains traceable and inspection-ready throughout the clinical study lifecycle.
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 eCOA works inside a unified clinical trial software?
When electronic clinical outcome assessment operates inside a unified clinical trial software, outcome data becomes directly connected to the entire clinical study workflow. Patient-reported outcomes, clinician assessments, biomarker data, and continuous monitoring streams remain synchronized within a single platform instead of being distributed across separate systems. This unified approach reduces:
Manual reconciliation between systems
Data transfer delays
Operational complexity in trial monitoring
Fragmented reporting workflows
Who This Is For
Who oomnia eCOA software is for
oomnia eCOA software is designed for organizations conducting modern, data-driven clinical trials. It is particularly valuable for:
Sponsors collecting patient-reported outcomes across multi-site studies
CROs implementing decentralized or hybrid clinical trials
Study teams monitoring patient outcomes between site visits
Organizations replacing paper-based questionnaires
Trials requiring high-frequency or continuous data collection (oncology, CNS, rare diseases, wearable-enabled studies)
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
RTSMRTSM software
Randomization and Trial Supply Management system that automates treatment allocation and blinding in real-time
ESOURCEeSource clinical trials
Electronic source system that captures original site data in real time, fully validated and without manual transcription
Get Started
Ready to digitize outcome assessments in clinical trials?
Transition from paper questionnaires to structured electronic clinical outcome assessment within a unified clinical trial solution.
Talk to our teamResources
eCOA resources
eCOA
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Frequently asked questions
What is eCOA software in clinical trials?
eCOA (Electronic Clinical Outcome Assessment) software is a digital solution for collecting clinical outcome data from patients, clinicians, and caregivers. Wemedoo's oomnia eCOA allows assessments to be completed on any device — smartphone, tablet, or computer — delivering cleaner data, fewer errors, and real-time insights.
What is the difference between eCOA and ePRO?
ePRO (Electronic Patient-Reported Outcomes) specifically captures data reported by patients, while eCOA is a broader category that includes patient-reported outcomes (PRO), clinician-reported outcomes (ClinRO), observer-reported outcomes (ObsRO), and performance outcomes (PerfO). oomnia eCOA software supports all four types.
What types of assessments does oomnia eCOA support?
oomnia eCOA supports validated instruments including PRO-CTCAE, EQ-5D, SF-36, VAS scales, ECOG performance status, and custom questionnaires. It handles patient diaries, clinician assessments, caregiver observations, and performance-based tests across any therapeutic area.
How does oomnia eCOA ensure data quality?
oomnia eCOA ensures data quality through real-time validation, time-stamped entries, automated compliance reminders, built-in edit checks, and a user-centered design that minimizes errors. All data flows directly into the unified clinical database for immediate review.
Can eCOA be used in decentralized clinical trials?
Yes, oomnia eCOA is ideal for decentralized and hybrid clinical trials because patients, clinicians, and caregivers can complete assessments from any location on any device. This supports remote data collection while maintaining the same data quality and compliance standards as site-based assessments.