Unified clinical trial software
Unified clinical trial software for immunology clinical trials
oomnia unifies clinical operations for immunology and inflammatory disease trials, helping teams track highly variable biomarkers and symptoms within one consistent environment for faster, more confident execution
INDUSTRY CONTEXT
Why immunology trials are hard to run
Immunology trials are challenging due to highly variable patient responses, complex biomarker requirements, and multi-endpoint study designs that demand tight coordination and consistent data capture. These challenges are particularly pronounced in autoimmune diseases, chronic inflammatory conditions, and infection-driven studies, where variability in immune response and disease progression directly impacts endpoint evaluation and trial design.
Key challenges include:
Frequent protocol adjustments driven by unpredictable disease activity, flare patterns, and immune-response variability
High-volume, multi-source data including biomarkers, labs, imaging, and digital endpoints that must be interpreted together
Multi-endpoint and longitudinal designs that require precise timing and consistent follow-up across extended study timelines
High operational complexity due to diverse patient phenotypes, specialized assessments, and intensive monitoring across sites
UNIFIED PLATFORM
Why unified clinical trial software matters for immunology trials
Immunology trials rely on multiple disconnected systems to manage clinical data, biomarker results, imaging, and real-world patient data.
This fragmented setup increases reconciliation effort, delays insight generation, and makes it difficult to maintain consistency across adaptive and biomarker-driven studies.
A unified clinical research information system (CRIS) connects all study components within one environment, enabling consistent data flow, improved data quality, and centralized oversight across global immunology programs.
| Area | Modular eClinical system | Unified clinical trial software (oomnia) |
|---|---|---|
| Data sources | Biomarkers, labs, imaging, and patient-reported data across separate systems | All immunology data unified in one system |
| Data consistency | Variability across sites, assays, and vendors | Standardized and harmonized data across all study components |
| Reconciliation | Manual alignment of biomarker, diagnostic, and clinical data | Reduced reconciliation through unified data model |
| Protocol changes | Complex updates due to flare patterns and immune variability | Configuration-based updates without system rebuild |
| Patient monitoring | Limited visibility into disease activity and flare cycles | Near real-time monitoring of immune response and symptoms |
| Endpoint tracking | Multi-endpoint tracking across disconnected tools | Centralized tracking of biomarkers, clinical outcomes, and endpoints |
| Study execution | Fragmented workflows across sites, labs, and vendors | Unified workflows across all stakeholders |
| Oversight | Limited visibility across complex, adaptive studies | Centralized, real-time oversight across global programs |
| Scalability | Difficult to manage global, biomarker-driven trials | Scalable across multi-country immunology studies |
CRIS ARCHITECTURE
One unified clinical trial platform for immunology trials
oomnia unifies multiple disconnected tools into one Clinical Research Information System (CRIS), giving immunology teams a coordinated framework built for variable disease activity, complex biomarkers, and multi-endpoint study designs
Purpose-built to support immunology and inflammatory disease trials within one coordinated environment, from enrollment through final analysis
Unified data foundation that keeps clinical, operational, biomarker, and patient-reported information naturally aligned throughout the study
Protocol adjustments tied to flare patterns or immune-response variability are managed through configuration rather than system rebuilds, minimizing disruption
Minimizes handoffs and reduces operational friction by replacing fragmented systems with one connected workflow across sites, labs, and vendors
ECOSYSTEM INTEGRATION
How oomnia fits into the immunology sponsor ecosystem
oomnia acts as the central operational and data backbone for immunology trials, connecting the systems and stakeholders required to manage variable disease activity, multi-endpoint designs, and high-complexity biomarker workflows
It connects with:
KEY CAPABILITIES
Core capabilities for immunology and inflammatory disease trials
Trial design and adaptation
- Supports complex, immune-mediated and pathogen-driven study designs, including flare-based, longitudinal, and multi-endpoint protocols
- Enables rapid configuration for evolving cohorts, immune-response subgroups, and assay-driven amendments
- Maintains study continuity during mid-protocol updates involving biomarkers, disease-activity scoring, or diagnostic workflows
Data capture and consistency
- Real-time collection and validation across diverse immunology and inflammatory disease datasets
- Harmonized data flow across EDC, CTMS, RTSM, ePRO/eCOA, eSource, eConsent, lab systems, and microbiology and serology data streams
- Reduces manual reconciliation and errors in high-complexity biomarker and pathogen-response data
Patient monitoring and engagement
- Flexible ePRO/eCOA for flare activity, symptom tracking, inflammatory-related events, and quality-of-life measures
- Supports remote monitoring for chronic immune conditions and outbreak-related studies
- Automated reminders help maintain adherence during long-term follow-up or variable disease-activity cycles
Operational oversight and analytics
- Real-time analytics combining clinical measures, immune biomarkers, inflammatory markers, imaging, and digital health data
- Enables interim analyses, safety reviews, immune-response monitoring, and rapid decision-making across global programs
- Export-ready datasets for regulatory agencies and inflammatory diseases public-health authorities
Imaging, biomarker, and diagnostic integration
- Integrates imaging used in immune-mediated conditions such as ultrasound, MRI, and endoscopy
- Connects immunology, microbiology, virology, and serology laboratory data directly with safety and response analytics
- Provides a unified view of disease activity, immune signatures, pathogen response, and clinical outcomes
Purpose-built for variable, biomarker-rich immunology and inflammatory diseases studies
Built on a unified data architecture connecting clinical, operational, and real-world data
Flexible configuration enables rapid adaptation to evolving endpoints, assays, and protocols
Reduces operational burden for sites, sponsors, and CROs
Removes the need to coordinate multiple disconnected systems for labs, imaging, diagnostics, and patient-reported data
VALUE PROPOSITION
Why sponsors choose oomnia for immunology 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 ecosystem readiness for immunology trials
oomnia equips immunology teams with a compliance-ready data environment that aligns with global regulatory and clinical-quality expectations
21 CFR Part 11–ready records
Fully compliant electronic records supporting 21 CFR Part 11, including complete audit trails and secure electronic signatures across all immunology and inflammatory disease study data
Risk-Based Quality Management
Risk-Based Quality Management (ICH E6(R3)) principles embedded into day-to-day study oversight for immune-mediated and pathogen-related trials
CDISC-aligned data structures
Data structures aligned with CDISC standards, with CDASH-based collection and SDTM-compatible outputs for immune biomarkers, diagnostics, and longitudinal disease-activity data
Global regulatory support
Purpose-built to streamline submissions to the FDA, EMA, and international regulatory and public-health agencies for immunology and inflammatory disease indications
Get Started
Plan your next immunology study with clarity
See how oomnia brings order to complex immunology trials, connecting data, workflows, and stakeholders from enrollment through final analysis
Talk to our team