Unified clinical trial software
Unified clinical trial software for ophthalmology trials
From first patient visit to database lock, oomnia keeps imaging, clinical, and patient‑reported data fully aligned for faster, compliant outcomes.
INDUSTRY CONTEXT
Why ophthalmology trials are hard to run
Ophthalmology trials require precise coordination of imaging, functional endpoints, and long-term follow-up, often across fragmented systems.
Key challenges include:
Coordinating visual function assessments within tight visit windows
Managing complex imaging data from multiple sources (Optical Coherence Tomography (OCT), fundus, etc.)
Long follow-up timelines with increased risk of patient dropout
Integrating outputs from imaging platforms and central reading centers
Operating across disconnected systems, increasing site burden and delays
UNIFIED PLATFORM
Why unified clinical trial software matters for ophthalmology trials
Ophthalmology trials rely on multiple systems to manage imaging, clinical data, and functional endpoints. This fragmented setup increases reconciliation effort, can delay access to consolidated imaging insights, and adds operational burden across sites and reading centers. A unified clinical trial platform, built as a Clinical Research Information System (CRIS), connects all study components within one environment, enabling more consistent data flow, improved data quality, and centralized oversight across ophthalmology trials.
| Area | Modular eClinical system | Unified clinical software (oomnia) |
|---|---|---|
| Imaging data | OCT, fundus, and imaging data stored in separate systems | All imaging and clinical data unified in one system |
| Data consistency | Variability across sites and reading centers | Standardized data across all study components |
| Reconciliation | Manual alignment of imaging and clinical data | Reduced reconciliation effort |
| Patient monitoring | Limited or delayed visibility into visual outcomes | Real-time tracking of patient data |
| Endpoint tracking | Complex management of Best-Corrected Visual Acuity (BCVA) and imaging endpoints | Centralized endpoint tracking |
| Study execution | Disconnected workflows across vendors | Unified workflows across sites and partners |
| Oversight | Limited visibility across imaging and clinical data | Centralized oversight across study data |
| Site burden | High administrative workload across systems | Reduced site burden through unified workflows |
CRIS ARCHITECTURE
One unified clinical trial software for ophthalmology trial execution
oomnia brings together all core ophthalmology trial workflows into one unified Clinical Research Information System (CRIS), helping teams manage imaging-heavy studies with greater efficiency and consistency. Built on a single architecture and data model, oomnia enables:
Execution across all trial phases
Real-time access to unified imaging and clinical data
Faster decision-making without data silos
Reduced operational complexity across sponsors, CROs, and sites
ECOSYSTEM INTEGRATION
How oomnia connects ophthalmology trial stakeholders
oomnia acts as a central data and operational hub connecting all stakeholders in ophthalmology trials.
It integrates with:
KEY CAPABILITIES
Key capabilities for ophthalmology trials
Trial design & adaptation
- Configurable endpoints (Best-Corrected Visual Acuity (BCVA), retinal thickness, visual fields, etc.)
- Flexible protocol execution across multi-year studies
- Adapts to protocol amendments without disrupting study execution
Data capture & quality
- Real-time data entry and validation
- Unified data flow across EDC, CTMS, RTSM, ePRO, eSource
- Reduces duplicate entry and manual reconciliation
Patient engagement
- Mobile-friendly ePRO for visual and functional assessments
- Automated reminders to reduce missed visits and improve adherence
Oversight & analytics
- Centralized dashboards combining imaging and clinical endpoints
- Supports monitoring and interim analysis workflows
- Enables generation of submission-ready datasets aligned with regulatory expectations
Imaging integration
- Integration with OCT, fundus photography, and imaging platforms
- Unified view of imaging + clinical outcomes
- Seamless connection with central reading centers
A truly unified clinical trial software is not integrated; it is built as a Clinical Research Information System (CRIS).
Single architecture vs fragmented systems
Real-time data access vs delayed reconciliation
Configuration instead of redevelopment
Unified imaging + clinical data in one system
Reduced site burden across complex workflows
VALUE PROPOSITION
Why sponsors choose oomnia for ophthalmology
Client Testimonials
Collaboration built on trust and innovation
Wemedoo's technology, expertise, and intimate engagement with our team in the development of the EDC, site/patient interface, and metric capabilities are unique. They provided insight and challenged the underlying assumptions to ensure the study's goals and objectives were clearly defined and the operating structure matched with the study's intent. Their system is not a one-size-fits-all and they adapt to the needs of the sponsor, sites, physicians, and the study requirements into a system that merges health information/data and can then become not only informative but actionable.
James Kuras
Vice President of Clinical Affairs and Operations at Centinel Spine
Wemedoo's cross-functional, integrated teams capture EDC set-up, go-live, data capture, data cleaning, and finally data analysis in a globally compliant fashion supporting trials in different geographies including the US. Their speed of addressing customer needs sets in my personal experience industry benchmark whilst keeping these data solutions lean and affordable. Besides the great proprietary systems they use, their integrated team approach with personal responsibility and honest commitment to targeting outcomes differentiates the Wemedoo team from other providers. Wemedoo only made Oxular's key initial trial, a device-drug trial possible, as based on some pre-work, the Wemedoo team could substantially adapt and update the first EDC ideas for a trial under a US FDA IND. The Wemedoo team worked extremely focused on familiarizing US trial sites and clinical CROs with the use of their system, which turned out to be a key success factor of the respective trial. The highly professional and up-to-date capabilities in data sciences were mirrored by customer-centricity and super fast timelines of integrating mandatory adaptations to the data systems.
Friedrich Asmus
Former Chief Medical Officer at OXULAR
All jobs, both large and small, are performed with the same dedication to quality, detail, innovative thinking, and rigor. It is always a pleasure to work with the Wemedoo team.
Georg Mathis, PhD
CEO at Appletree CI Group AG
Wemedoo embodies all the traits desired in a partner in the clinical trial industry – expertise, innovation, reliability, compliance, and attention to detail.
Martina Diminic Smetisko, DMD
Managing Director at Marti Farm Ltd
Their dedication to, and support of, our projects has resulted in clear quality deliverables. They are always there to answer any questions with expertise in a timely manner. I am looking forward to our next project together.
Volodymyr Stus, MD
Biopharmaceutics and Clinical Research Department Manager at Polpharma SA
Complex adaptive trials demand speed, precision, and system stability. With oomnia, Wemedoo's unified clinical trial software maintained continuous drug supply oversight, real-time data capture above 99%, and zero Randomization and Trial Supply Management (RTSM) dispensing errors throughout the study. The study reached database lock within 3 days after Last Patient Last Visit (LPLV), a direct result of integrated EDC–RTSM execution and proactive technical support. Wemedoo's technology and team responsiveness played a key role in meeting aggressive milestones.
Dhiraj Patel, Dr.
Director at Velocious Clinical Research
PLATFORM IMPACT
Quantified benefits
| Challenge area | Legacy baseline | oomnia approach | Measured impact |
|---|---|---|---|
| Enrollment timeline | 86% of trials miss targets ¹ | Streamlined consent & reduced site burden | Faster trial setup (up to 83% faster) |
| Central reading delays | 5–7 days standard | Integrated imaging with real-time quality checks | 70–80% faster query resolution |
| Platform proliferation | 5+ systems per trial | Single unified system, one login | Reduced operational delays & complexity |
| Drug supply overage | 200–300% overage typical ² | Predictive supply algorithms | 30–50% reduction in overage |
| Score interpretation | Low accuracy (manual scoring) | Automated calculations | Improved data accuracy & consistency |
| Database lock delays | Long reconciliation cycles | Real-time unified data (no silos) | Up to 90% faster database lock |
- ¹ Credevo. (2020). How to improve patient recruitment in clinical trials. https://credevo.com/articles/2020/03/31/how-to-improve-patient-recruitment-in-clinical-trials/#:~:text=According%20to%20the%20National%20Institutes
- ² Customer reported operational benchmark
REGULATORY READINESS
Built for regulatory confidence
oomnia supports compliant execution of ophthalmology trials by embedding regulatory standards, secure data handling, and quality oversight into unified imaging and clinical workflows
21 CFR Part 11 compliance
21 CFR Part 11‑ready records, complete with audit trails and secure electronic signatures
Risk-Based Quality Management
Risk‑Based Quality Management (ICH E6(R3)) incorporated directly into routine study workflows
CDISC-aligned data standards
CDISC-compliant data standards, including CDASH for data collection and SDTM-ready outputs for streamlined analysis and submission
Global regulatory submissions
Built to support regulatory submissions across FDA, EMA, and global authorities
Get Started
Manage complex ophthalmology trials with greater control
Unify imaging, clinical, and patient data in one platform to improve oversight, reduce site burden, and accelerate study execution.
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