Unified clinical trial software
Unified clinical trial software for infectious diseases clinical trials
oomnia unifies clinical operations for fast-moving, data-intensive infectious diseases trials by connecting real-time safety, virology, and operational data, enabling sponsors to streamline execution and maintain high-quality datasets
INDUSTRY CONTEXT
Why infectious diseases trials are hard to run
Infectious disease trials are challenging because patient outcomes shift quickly with changing symptoms, immune responses, and diverse real-world populations.
Key challenges include:
Rapidly changing symptoms and disease course, requiring adaptive protocols focused on clinically meaningful outcomes rather than fixed, late-stage measures
Lab pathogen data that often fails to predict real clinical benefit, making endpoint selection complex and outcome-driven designs essential
Need to enroll real-world, heterogeneous patients rather than just pathogen-confirmed cases, increasing site and data management complexity
Outbreak-driven timing pressures, where incidence can rise and fall before sites activate, compressing enrollment windows
High monitoring burden, including frequent safety checks and repeated microbiology and virology testing across geographically dispersed sites
UNIFIED PLATFORM
Why unified clinical trial software matters for infectious diseases trials
Infectious disease trials must respond quickly to changing conditions, often spanning multiple regions while collecting time-sensitive clinical, laboratory, and epidemiological data. When trial activities are managed across disconnected systems, teams struggle to keep data synchronized, monitor emerging trends, and act fast as protocols or public-health guidance evolves.
A unified clinical trial platform, built as a Clinical Research Information System (CRIS), consolidates study operations into a single working environment.
This enables coordinated execution, reliable data flow, and near-real-time visibility across infectious disease studies, supporting faster decisions during periods when speed, consistency, and accuracy are critical.
| Area | Modular eClinical system | Unified clinical trial software (oomnia) |
|---|---|---|
| Data types | Clinical outcomes, lab results, virology data, and surveillance inputs stored separately | All trial and laboratory data unified in one CRIS |
| Data consistency | Inconsistencies across regions, labs, and sites | Standardized data capture across all locations |
| Reconciliation | Manual alignment of clinical, lab, and safety data | Reduced reconciliation through a shared data model |
| Patient monitoring | Delayed insight into infection status and treatment response | Real-time visibility into patient outcomes and trends |
| Study execution | Disconnected workflows across sites, labs, and partners | Coordinated workflows across the full trial network |
| Data quality | Higher risk of missing or delayed data during rapid enrollment | Structured data capture with built-in validation |
| Oversight | Limited situational awareness across sites and regions | Centralized oversight across all study components |
| Scalability | Difficult to scale during outbreaks or multi-region studies | Designed to support rapid expansion and global deployment |
CRIS ARCHITECTURE
One unified clinical trial platform for infectious diseases trials
oomnia provides a unified clinical research information system (CRIS) for infectious disease trials, replacing fragmented systems with a single connected workflow built for fast-changing, outcome-focused studies
Purpose-built for trials where symptoms, immune response, and disease severity evolve quickly, requiring real-time data alignment across clinical, safety, and virology streams
Powered by a unified data model that keeps safety, virology, clinical status, and operational data continuously aligned at the patient level
Protocol adjustments are configurable, allowing teams to respond to shifting disease patterns or emerging evidence without rebuilding systems or disrupting ongoing execution
Reduces handoffs and operational friction by replacing multiple point solutions with one connected workflow designed for outbreak-driven, high-variability infectious disease studies
ECOSYSTEM INTEGRATION
How oomnia fits into the infectious diseases clinical trial ecosystem
oomnia brings together the key data streams in infectious disease studies, creating a single connected environment for all trial stakeholders
It connects with:
KEY CAPABILITIES
Key capabilities for infectious diseases trials
Trial design and adaptation
- Supports outcome-focused, rapidly evolving infectious disease protocols, including multi-arm and severity-based designs
- Enables rapid configuration when case definitions shift, new variants emerge, or enrollment criteria change
- Minimizes disruption during mid-study updates driven by changing disease patterns or updated clinical guidance
Data capture and quality
- Real-time capture and validation of safety, symptoms, vitals, pathogen load, and diagnostic results
- Unified data flow across EDC, CTMS, RTSM, ePRO/eCOA, eTMF, eSource, and eConsent to consolidate high-volume infectious disease data
- Reduces manual reconciliation and prevents duplicate entries across clinical, microbiology, and virology datasets
Patient engagement
- Flexible ePRO/eCOA to track symptom progression, fever patterns, respiratory status, and treatment response
- Supports remote and on-site data capture to accommodate quarantine, isolation, or limited mobility
- Automated reminders reduce missed assessments during short-interval, high-frequency monitoring schedules
Oversight and analytics
- Real-time dashboards combining clinical status, safety events, virology and microbiology results, and diagnostic data
- Supports interim analyses, Data Monitoring Committee reviews, and early-signal detection across global infectious disease programs
- Export-ready outputs for regulatory submissions across FDA, EMA, and global infectious-disease authorities
Diagnostics and laboratory integration
- Integrates data from PCR, antigen, serology, and culture-based diagnostics directly into the trial environment
- Connects microbiology and virology results with safety monitoring and clinical outcome analytics
- Provides a consolidated view of symptom resolution, pathogen dynamics, and patient-level clinical outcomes
Designed for fast-moving, outcome-focused infectious disease research where protocols and case definitions evolve rapidly
Built on a single relational architecture instead of fragile point-to-point integrations
Configuration enables quick adaptation as case definitions or disease patterns change
Reduces operational burden for sites, sponsors, and CROs in high-variability environments
Replaces multiple disconnected systems with one unified infectious disease workflow
VALUE PROPOSITION
Why sponsors choose oomnia for infectious disease 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 infectious diseases trials
oomnia delivers an infectious-diseases-ready, compliance-aligned data environment that meets global regulatory expectations
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 infectious disease studies
Risk-Based Quality Management
Risk-Based Quality Management (ICH E6(R3)) built directly into day-to-day study workflows, helping teams focus oversight where rapidly changing data matters most
CDISC-aligned data structures
CDISC-aligned data standards, including CDASH for collection and SDTM-compatible outputs, suitable for infectious disease regulatory submissions
Global regulatory support
Supports regulatory submissions to FDA, EMA, and global infectious-disease authorities across fast-moving, multi-region, and outbreak-driven programs
Get Started
Plan your next infectious disease trial with clarity
See how oomnia simplifies fast-moving infectious disease clinical trials by unifying critical data and operations across the full study lifecycle
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