Unified clinical trial software
Unified clinical trial software for complex oncology trials
oomnia unifies clinical operations for adaptive, data‑intensive oncology trials, helping biotech and mid‑market pharma improve execution and strengthen data quality across global studies
INDUSTRY CONTEXT
Why oncology trials are hard to run
Oncology trials are hard to run due to adaptive designs, high data volume, and multi-source data dependencies.
Key challenges include:
Frequent protocol changes driven by complex study designs
High-volume, multi-source data (clinical, imaging, biomarker, safety)
Tight timelines in competitive indications
Global, multi‑center operational complexity
High site burden combined with strict data quality requirements
UNIFIED PLATFORM
Why unified clinical trial software is essential for oncology trials
When oncology trials depend on separate systems to manage clinical data, imaging, biomarker results, safety reporting, and operational workflows, teams encounter fragmented information, slow decision-making, and heavy operational load on sites and study teams. A unified clinical trial platform built as a Clinical Research Information System (CRIS) brings oncology-specific data and processes together within a single, centralized environment designed for complex, data-intensive oncology research.
| Challenge area | Legacy performance | oomnia result |
|---|---|---|
| Protocol amendment costs | Up to $535K | Configuration changes in hours |
| Drug supply overage | 200–300% typical | Reduced to 30–50% |
| Database lock delays | 50% from non-CRF data reconciliation | Removed by design |
| Query management | ~96,980 queries per Phase III | Real-time edit checks prevent errors at entry |
| Site workload | 98% Manual re-entry across systems | Single interface, single sign-on |
This model supports continuous alignment of clinical, imaging, and biomarker data, improves visibility into patient outcomes and safety signals, and enables more efficient execution of multi-arm, multi-site oncology studies.
CRIS ARCHITECTURE
One unified clinical trial platform for oncology trials
oomnia unifies eight separate tools into one clinical research information system (CRIS), giving oncology teams a streamlined framework built for complex, adaptive studies
Purpose-built to support adaptive, biomarker-driven oncology designs within one coordinated environment
Powered by a single data model that keeps clinical, operational, and patient data continuously aligned
Protocol updates are managed through configuration, allowing studies to adjust without system rebuilds
Minimizes handoffs and reduces friction by replacing fragmented systems with one connected workflow
ECOSYSTEM INTEGRATION
How oomnia connects sponsors, data, and sites in oncology trials
oomnia acts as a central clinical data hub connecting all stakeholders across the oncology trial ecosystem
It integrates:
KEY CAPABILITIES
Key capabilities for oncology trials
Trial design and adaptation
- Supports multi‑arm, adaptive, and biomarker‑driven oncology protocols
- Enables rapid configuration when cohorts expand or protocol amendments occur
- Minimizes disruption during mid‑study changes and complex schema updates
Data capture and quality
- Real‑time data entry and validation across high‑volume oncology datasets
- Unified data flow across EDC, CTMS, RTSM, ePRO/eCOA, eTMF, eSource, and eConsent
- Reduces manual reconciliation and eliminates duplicate data entry
Patient engagement
- Flexible ePRO/eCOA for symptom burden, toxicity, and quality‑of‑life reporting
- Remote and in‑clinic patient data capture to support long, intensive treatment cycles
- Automated reminders reduce missed assessments and improve visit adherence
Oversight and analytics
- Real‑time dashboards combining clinical, imaging, laboratory, and biomarker data
- Supports interim analyses, safety reviews, and decision‑making across global programs
- Export‑ready outputs for regulatory submissions (FDA, EMA, global authorities)
Imaging and biomarker integration
- Integrates imaging data flowing from central reading centers into the unified clinical trial software
- Connects laboratory and biomarker data directly with safety monitoring and analytics
- Provides a consolidated view of clinical outcomes, imaging, and molecular endpoints
Designed specifically for adaptive, biomarker‑driven oncology research
Built on a single relational architecture rather than layered integrations
Configuration replaces redevelopment when protocols evolve
Reduces operational friction for sites, sponsors, and CROs
Eliminates the need to manage multiple disconnected systems
VALUE PROPOSITION
Why sponsors choose oomnia for oncology 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 oncology teams with a compliance‑ready data environment that meets global regulatory expectations
21 CFR Part 11 compliance
21 CFR Part 11‑ready records, complete with audit trails and secure electronic signatures
Risk-Based Quality Management
Risk‑Based Quality Management (ICH E6(R3)) incorporated directly into routine study workflows
CDISC-aligned data standards
CDISC‑aligned data standards, including CDASH for collection and SDTM‑compatible outputs
Global regulatory submissions
Built to support regulatory submissions across FDA, EMA, and global authorities
Get Started
Design your next oncology trial with confidence
Discover how oomnia streamlines complex oncology studies, unifying data, workflows, and teams from first patient in to database lock
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