Unified clinical trial software
Unified clinical trial software for respiratory clinical trials
oomnia connects spirometry, FeNO, imaging, exacerbation data, and patient-reported outcomes in one unified CRIS, giving respiratory trial teams complete visibility and control from protocol to submission
INDUSTRY CONTEXT
Why respiratory clinical trials are hard to run
Respiratory trials generate diverse and complex data — from spirometry and FeNO to HRCT imaging and exacerbation diaries — across large, heterogeneous patient populations and geographically dispersed sites.
Key challenges include:
Multiple, heterogeneous data types — spirometry, FeNO, HRCT imaging, exacerbation diaries, and patient-reported outcomes — that require integration across separate systems
Exacerbation-based endpoint designs that depend on timely, accurate event capture from patients and sites in real time
Large and diverse patient populations across asthma, COPD, IPF, and other chronic lung conditions, each with distinct endpoints and disease monitoring requirements
Geographically dispersed site networks with variable pulmonary function testing equipment, imaging infrastructure, and eCOA capabilities
Chronic disease timelines requiring long-term follow-up, adherence monitoring, and consistent data quality over extended periods
Regulatory complexity across global markets, including FDA, EMA, and other authorities with evolving expectations for respiratory endpoints and real-world evidence
UNIFIED PLATFORM
Why unified clinical trial software matters for respiratory studies
Respiratory trials are data-intensive by nature. Spirometry results, FeNO measurements, HRCT reads, exacerbation reports, safety events, and patient-reported symptom scores must all be connected at the patient level to support meaningful analysis and regulatory-ready datasets. When these data streams are managed in separate systems, teams spend significant time on reconciliation rather than trial oversight.
A unified clinical trial platform, built as a Clinical Research Information System (CRIS), brings all study elements into one shared environment. Clinical, operational, imaging, and patient-reported data flow through a single data model, enabling real-time visibility and reducing the manual effort required to align data from disconnected sources.
This unified approach helps respiratory sponsors maintain data integrity, accelerate query resolution, and generate regulatory-ready outputs across complex, multi-endpoint studies.
| Area | Modular eClinical system | Unified clinical trial software (oomnia) |
|---|---|---|
| Spirometry & FeNO | Captured in standalone pulmonary function systems, transferred manually | Integrated directly into the clinical dataset via a unified data model |
| HRCT imaging | Managed by a separate imaging vendor with no link to clinical data | Connected to patient-level clinical data through ecosystem integration |
| Exacerbation capture | Reported through separate eCOA tools with manual reconciliation | Captured via integrated ePRO/eCOA within the same CRIS |
| Data consistency | Variation across sites and assessment types | Standardized data capture aligned across all endpoints and sites |
| Reconciliation | Manual matching of clinical, imaging, and PRO data | Reduced reconciliation through a shared data model |
| Patient monitoring | Limited real-time visibility into symptom burden and exacerbation rates | Real-time tracking of PRO, safety, and exacerbation data |
| Study execution | Disconnected workflows across sponsors, sites, and imaging vendors | Coordinated workflows across the entire study ecosystem |
| Oversight | Fragmented view of clinical, functional, and imaging endpoints | Unified oversight across all study components in one dashboard |
CRIS ARCHITECTURE
One unified clinical trial platform for respiratory studies
oomnia brings essential clinical and operational tools together in a single clinical research information system (CRIS), giving respiratory trial teams a connected, scalable way to manage data-intensive studies
Designed for multi-endpoint respiratory studies where spirometry, FeNO, imaging, exacerbation events, and patient-reported outcomes must be aligned at the patient level within one system
Uses a unified data model to connect pulmonary function data, biomarker results, safety events, and PRO assessments, ensuring consistent and traceable data across the full study timeline
Enables rapid protocol updates through configuration, allowing studies to adapt to new endpoint requirements, regulatory feedback, or protocol amendments without disrupting ongoing execution
Reduces site burden with one connected workflow, replacing multiple disconnected tools with a single interface for data entry, supply management, and patient engagement
ECOSYSTEM INTEGRATION
How oomnia fits into the respiratory sponsor ecosystem
oomnia serves as the central operational and data backbone for respiratory trials, connecting systems and stakeholders across the study lifecycle
It integrates:
KEY CAPABILITIES
Key capabilities for respiratory clinical trials
Trial design and endpoint configuration
- Supports complex respiratory study designs with multiple endpoints — spirometry, FeNO, exacerbation rates, imaging, and PRO — configured within a single system
- Enables rapid reconfiguration when protocols change due to regulatory feedback or emerging clinical evidence
- Minimizes disruption during amendments, allowing studies to adapt without rebuilding data structures or retraining site staff
Respiratory data capture and quality
- Unifies spirometry, FeNO, HRCT, laboratory, safety, and patient-reported data within a single CRIS, eliminating the need for separate systems and manual transfers
- Reduces transcription errors and query volume through direct integration with pulmonary function labs and imaging vendors
- Supports CDISC-aligned data structures for regulatory-ready outputs across FDA, EMA, and other global submissions
Patient engagement and remote monitoring
- Flexible ePRO/eCOA designed for respiratory symptom diaries, exacerbation reporting, and quality-of-life assessments across asthma, COPD, and other chronic indications
- Supports remote and decentralized participation, enabling patients to report data from home and reducing the frequency of on-site visits for chronic disease populations
- Automated reminders help maintain adherence and consistent data capture over long study timelines
Real-time oversight and safety monitoring
- Real-time dashboards combining spirometry trends, exacerbation rates, FeNO results, safety events, and patient-reported data across all sites
- Supports risk-based monitoring and interim analysis, enabling sponsors to identify data issues and protocol deviations early
- Produces regulatory-ready outputs to support submissions and interactions with FDA, EMA, and other global authorities
Imaging and biomarker integration
- Integrates HRCT reads, biomarker data, and pulmonary function results directly into the clinical dataset at the patient level
- Connects central imaging organizations and diagnostic labs to the study database, eliminating manual data transfers and reconciliation
- Provides a unified view of functional, imaging, and biomarker endpoints alongside clinical outcomes, supporting comprehensive safety and efficacy analysis
Built for multi-endpoint respiratory studies where spirometry, FeNO, imaging, exacerbation data, and PRO must be aligned in one system
Eliminates the reconciliation burden created by fragmented clinical, imaging, and patient-reported data streams
Supports large, diverse patient populations across asthma, COPD, IPF, and other chronic lung conditions
Uses configuration instead of redevelopment, enabling rapid adaptation to protocol amendments and regulatory requirements
Reduces operational burden for sites, sponsors, and CROs by replacing multiple disconnected tools with one unified interface
Produces CDISC-aligned, regulatory-ready datasets to support FDA, EMA, and global submissions
VALUE PROPOSITION
Why sponsors choose oomnia for respiratory 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 respiratory trials
oomnia provides a compliance-ready data environment designed to support evolving regulatory expectations across respiratory clinical trials
21 CFR Part 11–ready records
21 CFR Part 11–ready records with full audit trails and secure electronic signatures to support inspections and submissions across FDA-regulated respiratory studies
Risk-Based Quality Management
Risk-Based Quality Management (ICH E6(R3)) embedded into daily workflows, helping teams focus oversight on the data points that matter most in complex respiratory trials
CDISC-aligned data structures
CDASH-based collection and SDTM-compatible outputs suitable for regulatory submissions across asthma, COPD, IPF, and other respiratory indications
Global regulatory support
Built to support interactions and submissions across FDA, EMA, and global authorities, including studies requiring respiratory-specific endpoint validation and real-world evidence packages
Get Started
Plan your next respiratory study with clarity
Learn how oomnia connects spirometry, imaging, eCOA, and clinical data in one unified platform for respiratory trials
Talk to our team