Clinical Trial Software for CTUs
oomnia provides clinical trial management for clinical trial units (CTUs) units by bringing EDC, CTMS, eTMF, RTSM, and patient‑facing tools into one clinical research information system (CRIS), improving coordination and oversight across studies.
Industry Challenges
CTUs operate across multiple departments, systems, and stakeholders, making coordination and oversight inherently complex. Key challenges include:
Fragmented data from wearables, telehealth, apps, and legacy systems creates silos
Manual, time‑consuming workflows slow data cleaning and validation
Limited access to validated AI tools prevents proactive monitoring and automation
Evolving GDPR, HIPAA, and local rules increase compliance burden and complicate audits
Decentralized trial designs create data overload and reduce real‑time insight
Disconnected collaboration across hospitals, CTUs, CROs, and sponsors slows decisions
Reliance on local systems or paper slows adoption of unified, scalable cloud platforms
Our Solution
EDC, CTMS, eTMF, RTSM, eConsent, ePRO/eCOA, and eSource operate within one CRIS
Research teams gain role-based insight into study progress, sites, subjects, and documentation
Reusable forms, templates, and built‑in workflows
Audit trails, e‑signatures, and validation‑ready workflows support inspection readiness
The Platform
eConsent software
Digital informed consent solution enabling secure and compliant participant consent capture across studies
EPROePRO software
Electronic patient-reported outcomes tool designed for real-time data entry directly from participants
RTSMRTSM software
Randomization and Trial Supply Management system for automated treatment allocation and supply tracking
CTMSCTMS software
Clinical trial management system supporting efficient planning, tracking, and oversight of study activities
EDCEDC software
Electronic Data Capture platform for accurate, compliant, and real-time clinical data collection
ETMFeTMF software
Centralized system for organizing, maintaining, and accessing trial master file documentation
ECOAeCOA software
Digital solution for capturing patient, clinician, and observer-reported outcomes in real time
ESOURCEeSource clinical trials
Electronic source data capture system enabling direct entry of site data without manual transcription
Why It Matters
Many CTUs rely on separate tools for data capture, trial management, documentation, and patient engagement. While functional, this setup creates gaps in oversight, delays in data availability, and increased administrative burden.
A unified clinical trial platform, built as a Clinical Research Information System (CRIS), connects all study functions within a single environment.
This enables consistent data flow, role-based access across departments, and improved coordination across complex hospital research structures.
Fragmented Tools
Data spread across disconnected systems and spreadsheets
Manual document tracking and version control across studies
Inconsistent audit trails and compliance gaps
High administrative burden on limited CTU staff
Unified Clinical Trial Software (oomnia)
All study data and documents in one centralized system
Automated workflows and structured document management
One unified audit trail across all study operations
Faster study execution with reusable templates and reduced overhead
SIDE BY SIDE
| Area | Modular eClinical system | Unified clinical trial software (oomnia) |
|---|---|---|
| Data flow | Data spread across CTU systems, tools, and vendors | Data flows within one system in real time |
| Reconciliation | High manual reconciliation across departments and systems | Reduced reconciliation through shared data model |
| Visibility | Limited, delayed insights across departments and sites | Real-time, role-based visibility across all study activities |
| Audit trails | Multiple audit logs across systems and departments | One unified audit trail |
| Team workload | Time spent aligning data between departments and external teams | More time for oversight and clinical decision-making |
| Patient data access | Fragmented across EHRs, systems, and study tools | Unified patient-level view across study data and documentation |
| Patient safety | Delayed visibility into patient status and adverse events | Faster access to safety-related data |
| Regulatory readiness | Harder to maintain traceability across CTU systems | Improved traceability and inspection readiness |
| Operational speed | Slower due to coordination across departments and vendors | Faster study execution and coordination |
Regulatory Readiness
oomnia is designed to support the strict regulatory demands of CTUs research environments, helping maintain compliance, keep documentation organized, and stay inspection‑ready at every step of the study
GxP-aligned processes
Designed to support GxP‑aligned clinical research practices
21 CFR Part 11
Electronic records and signatures structured to meet 21 CFR Part 11 expectations
ICH-GCP Standards
Workflows and oversight processes built around ICH‑GCP requirements
GDPR
Data management and privacy handled in accordance with GDPR standards
Audit Trails
A single audit trail providing full traceability across all study activity
Validation Documentation
Documentation and system support suitable for validation and continuous compliance
Get Started
Unify data, workflows, and teams across departments and sites to improve coordination and reduce administrative burden
Talk to our team