Unified clinical trial software
Unified clinical trial software for rare and orphan diseases
oomnia brings structure and continuity to rare and orphan disease studies, enabling teams to manage small, globally distributed patient populations while maintaining high‑quality, regulatory‑ready data
INDUSTRY CONTEXT
Why rare and orphan disease trials are hard to run
Clinical trials in rare and orphan diseases face operational and scientific challenges due to small patient populations, limited clinical knowledge, and the need for flexible study designs.
Key challenges include:
Very small and geographically dispersed patient populations, requiring global site networks, remote participation, and alternative recruitment strategies
Incomplete natural history and limited prior data, making protocol design, endpoint selection, and statistical planning more complex
Adaptive and evolving study designs, as new insights emerge during the trial
High dependency on heterogeneous data sources, including clinical outcomes, registries, biomarkers, patient‑reported outcomes, and long‑term follow‑up data
Significant operational burden on sites and sponsors, where each patient represents a critical data point
Extended timelines and ongoing evidence generation, often required to support post‑approval commitments
UNIFIED PLATFORM
Why unified clinical trial software matters for rare and orphan disease studies
Rare and orphan disease trials are often conducted across a small number of highly specialized sites, rely on diverse data types, and extend over long timelines to capture meaningful outcomes. When clinical, operational, and patient data are spread across multiple tools, teams lose visibility and spend valuable time reconciling information rather than advancing the study.
A unified clinical trial platform, built as a Clinical Research Information System (CRIS), brings all study elements into one shared environment.
This unified approach helps sponsors maintain consistency, preserve data integrity, and gain real‑time insight across rare and orphan disease studies.
| Area | Modular eClinical system | Unified clinical trial software (oomnia) |
|---|---|---|
| Data types | Separate systems for clinical outcomes, patient-reported data, labs, and specialty diagnostics | All study data unified in one CRIS |
| Data consistency | Variation across sites, assessments, and vendors | Standardized data capture across all stakeholders |
| Reconciliation | Manual matching of clinical, safety, and follow‑up data | Reduced reconciliation through a shared data model |
| Patient monitoring | Limited visibility into longitudinal disease progression | Real‑time tracking of long‑term patient outcomes |
| Study execution | Disconnected workflows across sponsors, sites, and partners | Coordinated workflows across the entire study ecosystem |
| Data quality | Higher risk of gaps or inconsistencies over long timelines | Structured data capture with built‑in checks |
| Oversight | Fragmented view of study status and patient data | Unified oversight across all study components |
| Scalability | Difficult to manage small populations across long studies | Built to support distributed sites and extended follow‑up |
CRIS ARCHITECTURE
One unified clinical trial platform for rare and orphan disease studies
oomnia brings essential clinical and operational tools together in a single clinical research information system (CRIS), giving rare and orphan disease teams a simple, flexible way to run data‑critical studies
Designed for adaptive rare and orphan disease studies, where endpoints, cohorts, and protocols evolve as evidence emerges
Uses a unified data model to connect clinical outcomes, patient-reported data, and long-term follow-up at the patient level, ensuring consistent and traceable data across the study
Enables fast protocol updates through configuration, allowing studies to adapt without disrupting ongoing execution
Reduces burden on global sites with one connected workflow, ensuring every patient and data point is captured, traceable, and usable
ECOSYSTEM INTEGRATION
How oomnia fits into the rare and orphan disease sponsor ecosystem
oomnia serves as the central operational and data backbone for rare and orphan disease trials, connecting systems and stakeholders across the study lifecycle
It integrates:
KEY CAPABILITIES
Key capabilities for rare and orphan disease trials
Trial design and adaptation
- Supports flexible and adaptive study designs where protocols evolve as evidence develops
- Enables rapid reconfiguration when cohorts, endpoints, or eligibility criteria change
- Minimizes disruption during amendments driven by emerging data, regulatory feedback, or natural history insights
Data capture and quality
- Supports accurate, real‑time data capture where every patient contributes critical evidence
- Unifies data across EDC, CTMS, RTSM, ePRO/eCOA, eTMF, eSource, and eConsent within a single CRIS
- Reduces manual reconciliation and helps maintain data consistency across long study timelines
Patient engagement
- Flexible ePRO/eCOA designed for disease‑specific symptoms, functional measures, and quality‑of‑life outcomes
- Supports remote and site‑based data capture, enabling participation across dispersed patient populations
- Automated reminders help maintain adherence and consistent long-term follow-up
Oversight for long‑term and small‑cohort studies
- Real‑time dashboards combining clinical outcomes, laboratory results, safety data, and patient‑reported data
- Supports ongoing safety review and interim evaluation, even with small cohorts
- Produces regulatory‑ready outputs to support orphan designation submissions and interactions with FDA, EMA, and other authorities
Specialty diagnostics and biomarker integration
- Integrates data from specialty labs, genetic testing, and disease‑specific diagnostics
- Connects biomarker and laboratory data with safety monitoring and analytics in one system
- Provides a unified view of clinical outcomes and specialized endpoints, supporting decision‑making and evidence generation
Designed for small, adaptive studies where protocols, endpoints, and evidence requirements evolve over time
Maximizes the value of limited patient data across long study timelines
Built on a single, unified CRIS architecture, avoiding the complexity and risk of fragmented integrations
Uses configuration instead of redevelopment, enabling rapid adaptation to new insights
Reduces operational burden for specialist sites, sponsors, and CROs
Eliminates the need to manage multiple disconnected systems
VALUE PROPOSITION
Why sponsors choose oomnia for rare and orphan 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 rare and orphan diseases
oomnia provides a compliance-ready data environment designed to support evolving regulatory expectations across rare and orphan disease 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
Risk‑Based Quality Management
Risk‑Based Quality Management (ICH E6(R3)) embedded into daily workflows, helping teams focus oversight where limited patient data matters most
Standards‑aligned data structures
CDASH‑based collection and SDTM‑compatible outputs suitable for orphan designation and submission needs
Global regulatory support
Built to support interactions and submissions across FDA, EMA, and global authorities, including post‑approval and long‑term evidence requirements
Get Started
Built for the realities of rare and orphan disease trials
Learn how oomnia simplifies trial execution by bringing data, workflows, and stakeholders together in one system
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