Unified clinical trial software
Unified clinical trial software for neurology trials
oomnia brings together all clinical workflows for neurology trials, enabling smoother coordination, cleaner data, and stronger oversight across distributed teams
INDUSTRY CONTEXT
Why neurology clinical trials are hard to run
Neurology trials are difficult to execute because they involve diverse patient populations, subjective outcome measures, and high variability in disease progression. These factors make it harder to detect treatment effects, maintain data quality, and ensure consistent study execution across sites.
Key execution challenges include:
High complexity from multi‑modal biomarker data
Inconsistent capture methods across sites, devices, and readers
Difficulty maintaining data quality for long‑term, continuous tracking
Fragmented data flows across labs, imaging, and digital tools
Subjective or variable assessments that require centralized oversight
Extra workload from specialized reviews and hard‑to‑standardize measures
UNIFIED PLATFORM
Why unified clinical trial software matters for neurology trials
Neurology trials rely on multiple disconnected systems to manage imaging, clinical data, cognitive assessments, and operational workflows. This fragmentation creates inconsistencies, delays, and significant reconciliation effort.
A unified clinical trial platform, built as a Clinical Research Information System (CRIS), connects all study components within one environment. This enables consistent data flow, improved data quality, and real-time oversight across complex central nervous system (CNS) studies.
| Area | Modular eClinical system | Unified clinical trial software (oomnia) |
|---|---|---|
| Data types | Imaging, cognitive, and biomarker data stored in separate systems | All multi-modal data unified in one system |
| Data consistency | Variability across sites, raters, and vendors | Standardized data across all study components |
| Reconciliation | Manual alignment of imaging, clinical, and assessment data | Reduced reconciliation through shared data model |
| Patient monitoring | Delayed visibility into disease progression | Real-time tracking of longitudinal patient outcomes |
| Study execution | Disconnected workflows across systems and partners | Unified workflows across sites, CROs, and vendors |
| Data quality | Higher risk of missing or inconsistent data | Structured data capture with built-in validation |
| Oversight | Limited visibility across CNS data streams | Real-time oversight across all modalities |
| Scalability | Difficult to manage long, complex CNS trials | Scalable across multi-site and long-duration studies |
CRIS ARCHITECTURE
One unified clinical trial platform for neurology trials
oomnia brings all core neurology trial operations into one unified clinical research information system (CRIS), helping teams manage complex, data‑heavy studies with greater speed and consistency
Built for neurology's multi‑modal data needs, with a strong focus on complex biomarker and hard‑tracking measures
Single data model keeps clinical, operational, and assessment data aligned, reducing cross‑site variability and creating a stable structure for high‑volume biomarker streams
Protocol updates handled through configuration, enabling adjustments without system rebuilds
Replaces fragmented tools with one connected workflow, cutting handoffs and minimizing reconciliation
ECOSYSTEM INTEGRATION
How oomnia fits in the neurology sponsor ecosystem
oomnia serves as the centralized operational and data hub for neurology trials, connecting all stakeholders and unifying the diverse, multi‑modal data needed for CNS research
It integrates:
KEY CAPABILITIES
Key capabilities for neurology trials
Study design and protocol evolution
- Supports complex CNS study structures, including multi‑modal assessments, long‑term follow‑up, and variable visit schedules
- Enables rapid configuration updates when assessments, visit windows, or rater‑based measures change
- Minimizes operational disruption during mid‑study adjustments across sites, raters, and vendors
Data capture and quality
- Real‑time entry and validation across imaging, cognitive tests, clinician‑rated scales, digital measures, and standard clinical data
- Unified data flow across EDC, CTMS, RTSM, ePRO/eCOA, eTMF, eSource, and eConsent within one system
- Reduces manual reconciliation and eliminates duplicate entry across fragmented neurology data streams
Patient engagement
- Flexible ePRO/eCOA to collect symptom reporting, functional assessments, mood scales, and daily‑living measures
- Supports both remote and on‑site data capture, ideal for long, variable, or burdensome neurology visit schedules
- Automated reminders help reduce missed assessments and support adherence over extended study timelines
Oversight and analytics
- Real‑time dashboards combining clinical data, imaging outputs, cognitive assessments, and longitudinal measures
- Supports interim reviews, data safety monitoring board (DSMB) updates, and operational decision‑making across multi‑country CNS programs
- Export‑ready outputs for global regulatory submissions and centralized review requirements
Imaging and biomarker integration
- Seamlessly integrates neuroimaging data from central reading centers (MRI, fMRI, PET, CT) into the unified system
- Connects CNS biomarker and laboratory results directly with safety monitoring and analytics workflows
- Provides a consolidated view of clinical outcomes, imaging trends, and biological indicators in one place
Optimized for CNS study workflows, supporting imaging, cognitive tests, and clinician‑rated assessments
Runs on one unified architecture, removing the slow, layered integrations common in neurology trials
Easily adapts to protocol updates through configuration rather than system rebuilds
Reduces operational friction across sites, CROs, and central services with a single connected workflow
VALUE PROPOSITION
Why sponsors choose oomnia for neurology 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
oomnia provides neurology teams with a compliance‑ready environment that meets the rigorous regulatory and data‑integrity expectations of CNS trials
21 CFR Part 11 compliance
21 CFR Part 11–compliant records with secure signatures and full audit trails
Risk-Based Quality Management
ICH E6(R3)–aligned RBQM built directly into routine oversight
CDISC-aligned data standards
CDISC‑aligned structures with CDASH collection and SDTM‑ready outputs
Global regulatory support
Global regulatory support, including FDA, EMA, PMDA, and regional agencies
Inspection-ready traceability
Inspection‑ready traceability across imaging, cognitive, and rater‑based data
Get Started
Manage complex neurology trials with greater control
Bring imaging, cognitive assessments, and clinical data into one unified environment to improve oversight, reduce operational complexity, and accelerate study execution.
Talk to our team