Unified clinical trial software
Unified clinical trial software for gastroenterology clinical trials
oomnia supports gastroenterology research by unifying clinical workflows and study data, helping teams manage complex gastrointestinal (GI) trials from study start-up through completion
INDUSTRY CONTEXT
Why gastroenterology trials are difficult to run
Gastroenterology trials are challenging due to variable symptom presentation, reliance on subjective and objective endpoints, and the complexity of managing chronic and relapsing gastrointestinal conditions over time.
Key challenges include:
Unpredictable disease courses with flare-ups and remission, making endpoint timing and interpretation difficult
Heavy reliance on patient-reported symptoms alongside clinical, laboratory, and endoscopic data
High variability in treatment response, requiring larger study populations and careful subgroup definition
Burdensome procedures such as endoscopy and biopsies that impact recruitment, retention, and site workload
Operational complexity in maintaining data quality and patient engagement across long-term GI studies
UNIFIED PLATFORM
Why unified clinical trial software is essential for gastroenterology trials
When GI studies rely on disconnected systems to handle symptoms, laboratory data, endoscopy results, and operations, teams face data silos, delayed insight, and significant burden on sites.
A unified clinical trial platform built as a Clinical Research Information System (CRIS) brings gastroenterology-specific data and workflows into a single, coordinated environment designed for procedural and symptom-driven research.
This approach enables reliable longitudinal data tracking, clearer visibility into disease activity and treatment effects, and more efficient execution across complex, multi-site gastroenterology programs.
| Area | Modular eClinical system | Unified clinical trial software (oomnia) |
|---|---|---|
| Data sources | Symptoms, labs, procedures, and clinical data spread across multiple systems | All GI-relevant data managed within one integrated platform |
| Procedure data | Endoscopy, histology, and imaging tracked separately from clinical data | Procedural findings captured and aligned with clinical outcomes |
| Symptom variability | Inconsistent mapping of symptom scores over time | Standardized symptom tracking across visits and sites |
| Longitudinal analysis | Difficulty comparing disease activity across flares and remission | Consistent longitudinal view of GI outcomes and trends |
| Reconciliation effort | Manual alignment of lab, symptom, and procedure datasets | Reduced reconciliation through a shared data foundation |
| Protocol changes | Updates require rework across multiple systems | Configuration-based updates without disrupting ongoing studies |
| Patient follow-up | Gaps in visibility across repeated visits and procedures | Continuous tracking of patient status over long follow-up |
| Site workload | High burden from multiple tools and duplicate entry | Simplified workflows within a single system |
| Data quality | Higher risk of missing or inconsistent data | Structured capture with real-time validation |
| Oversight | Delayed insight into safety and disease progression | Real-time oversight across symptoms, labs, and procedures |
| Scalability | Difficult to manage multi-year, multi-center GI trials | Scales across global, long-duration gastroenterology programs |
CRIS ARCHITECTURE
One unified platform built for gastroenterology trials
oomnia is built to address the operational and data challenges of gastroenterology trials, enabling streamlined workflows and centralized management of GI-specific clinical data
Brings together GI symptom data, laboratory results, endoscopic findings, and outcomes in one centralized system, eliminating manual reconciliation across disconnected tools
Supports frequent assessments and protocol adjustments driven by disease flares, remission cycles, and evolving study designs
Reduces site workload by replacing fragmented tools with streamlined, end-to-end workflows tailored to the demands of GI research
Enables consistent data quality and real-time oversight across multi-site, long-running gastroenterology programs
ECOSYSTEM INTEGRATION
How oomnia supports the gastroenterology trial ecosystem
oomnia brings together the diverse data sources and stakeholders involved in gastroenterology trials, helping teams manage symptom-driven disease, procedural data, and long-term follow-up within a single, coordinated study environment
It integrates:
KEY CAPABILITIES
Key capabilities for gastroenterology trials
Trial design and adaptation
- Supports gastroenterology study designs involving fluctuating disease activity, frequent assessments, and complex visit schedules
- Enables efficient configuration updates when eligibility criteria, endpoints, or assessment timing change due to symptom variability or protocol evolution
- Preserves data continuity during protocol amendments without disrupting ongoing patient follow-up
Data capture and quality
- Enables real-time data capture and validation across GI-specific datasets, including clinical assessments, laboratory results, endoscopic findings, and patient-reported outcomes
- Provides unified data flow across EDC, CTMS, RTSM, ePRO/eCOA, eTMF, eSource, and eConsent to support sustained gastroenterology study execution
- Reduces manual reconciliation by maintaining consistent data structures across all study systems
Symptom tracking and patient engagement
- Supports flexible ePRO/eCOA for GI symptom reporting, treatment adherence, and quality-of-life assessment in chronic and relapsing conditions
- Enables both remote and in-clinic data capture to accommodate frequent visits, procedures, and long-term follow-up
- Automated visit and assessment reminders help reduce missed data points in long-running GI studies
Oversight and analytics
- Provides consolidated dashboards combining clinical data, symptom scores, laboratory results, and procedural outcomes
- Supports ongoing safety monitoring, interim reviews, and trend analysis across gastroenterology studies
- Generates submission-ready outputs aligned with regulatory expectations for FDA, EMA, and global authorities
Laboratory and procedural data integration
- Integrates central and local laboratory data, including inflammatory markers and GI-relevant test results, into a unified study view
- Supports integration of procedure-derived data such as endoscopy and histology within study workflows
- Enables comprehensive analysis by linking clinical outcomes, symptom data, laboratory results, and procedural findings
Designed to support gastroenterology programs challenged by variable symptoms, mixed endpoints, and procedure-driven assessments
Built on a single, unified data model that aligns clinical findings, laboratory results, endoscopic data, and patient-reported outcomes
Configuration-based updates allow studies to adapt to evolving endpoints, visit schedules, and protocol changes common in GI research
Reduces operational complexity for sites, sponsors, and CROs managing frequent visits, procedures, and long-term follow-up
Unifies modular GI study systems into one platform built around the practical demands of gastroenterology clinical trials
VALUE PROPOSITION
Why sponsors choose oomnia for gastroenterology trials
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
REGULATORY READINESS
Regulatory and data readiness for gastroenterology trials
oomnia provides a compliance-ready data environment designed to support gastroenterology studies involving chronic, relapsing conditions, procedure-based endpoints, and diverse clinical and symptom data
21 CFR Part 11–compliant records
21 CFR Part 11–compliant electronic records with audit trails and controlled access across all gastroenterology study data
Risk-Based Quality Management
Built-in risk-based quality practices aligned with ICH E6(R3), supporting continuous oversight across long-running GI studies
CDISC-aligned data standards
Standardized data capture and downstream outputs aligned with CDISC principles to support consistent review of gastroenterology trial data
Global regulatory support
Designed to support regulatory submissions to the FDA, EMA, and other global health authorities for gastrointestinal indications
Get Started
Supporting modern gastroenterology trials with one unified platform
See how oomnia helps sponsors manage complex GI data and workflows with clarity, consistency, and control
Talk to our team