Unified clinical trial software
Unified clinical trial software for cardiovascular, renal, and metabolic (CVRM) trials
oomnia centralizes clinical operations for CVRM trials, enabling teams to manage data-heavy studies with streamlined workflows and connected systems
INDUSTRY CONTEXT
Why CVRM trials are hard to run
CVRM trials present unique operational and scientific challenges, driven by chronic disease progression, large patient populations, and interconnected clinical outcomes.
Common challenges include:
Long study durations and event-driven timelines that require sustained oversight across extended follow-up periods
Complex patient eligibility and comorbidity patterns across cardiovascular, renal, and metabolic conditions
Heavy reliance on continuous and device-generated data from wearables, remote monitoring tools, and imaging platforms
Large, geographically dispersed trials involving diverse site networks and multi-country patient populations
High operational load at the site level due to frequent assessments, data entry requirements, and safety monitoring
Strict safety oversight and monitoring requirements for adverse events including major adverse cardiovascular events (MACE)
UNIFIED PLATFORM
Why unified clinical trial software matters for CVRM trials
CVRM trials rely on multiple disconnected systems to manage clinical data, imaging, laboratory results, and real-world data streams.
This fragmented setup increases reconciliation effort, delays insight generation, and makes it harder to maintain consistency across long-duration, multi-site studies.
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 centralized oversight across large-scale CVRM programs.
| Area | Modular eClinical system | Unified clinical trial software (oomnia) |
|---|---|---|
| Data sources | Clinical, imaging, lab, and wearable data across separate systems | All CVRM data unified in one system |
| Data consistency | Inconsistencies across sites and vendors | Standardized data across all study components |
| Reconciliation | Manual alignment of lab, imaging, and clinical data | Reduced reconciliation effort |
| Patient monitoring | Delayed visibility into disease progression and events | Near real-time monitoring of longitudinal patient data |
| Endpoint tracking | Complex tracking of events like MACE across systems | Centralized tracking of endpoints and outcomes |
| Study execution | Disconnected workflows across partners | Unified workflows across sites, CROs, and vendors |
| Oversight | Limited visibility across large CVRM programs | Centralized, real-time portfolio-level oversight |
| Scalability | Difficult to manage large, global trials | Scalable across multi-country CVRM studies |
CRIS ARCHITECTURE
One unified clinical trial platform solution for CVRM trials
oomnia brings together multiple clinical trial functions into a unified Clinical Research Information System (CRIS), providing CVRM teams with infrastructure designed for large-scale, longitudinal, and event-driven studies
One shared data model across clinical, operational, and real-world data, keeping all CVRM study components aligned from enrollment through database lock
Supports cardiometabolic trials with diverse data sources and endpoints, including MACE, hospitalization, renal decline, and metabolic progression
Configuration-based updates enable protocol changes without system rebuilds, allowing studies to adapt to evolving clinical guidelines and endpoint definitions
Reduces fragmentation by replacing disconnected tools with one environment, simplifying collaboration across sites, sponsors, CROs, and data vendors
ECOSYSTEM INTEGRATION
How oomnia fits in the CVRM sponsor ecosystem
oomnia serves as a central operational and data hub for CVRM trials, connecting key systems and stakeholders across the study ecosystem
It connects with:
KEY CAPABILITIES
Core capabilities for CVRM trials
Study configuration and long-term outcome management
- Supports event-driven and longitudinal CVRM study designs focused on endpoints such as MACE, hospitalization, and disease progression
- Adapts efficiently to evolving clinical guidelines, endpoint definitions, and protocol refinements over extended trial durations
- Maintains study continuity during amendments, minimizing disruption across large, multi-country patient populations
Data aggregation and consistency
- Enables continuous data capture and validation across diverse CVRM sources, including clinical visits, laboratory results, imaging, and real-world data streams
- Unifies data across systems such as EDC, CTMS, ePRO/eCOA, eSource, eConsent, and safety platforms within a single framework
- Reduces the need for manual data reconciliation by harmonizing inputs from sites, vendors, and digital health technologies
Patient monitoring and engagement
- Supports hybrid trial models with both site-based and remote data collection, reflecting chronic disease management in CVRM populations
- Integrates patient-reported outcomes alongside continuous monitoring data from connected devices and wearables such as activity, heart rate, and glucose levels
- Uses automated reminders and structured workflows to improve adherence in long-duration studies
Operational oversight and endpoint tracking
- Provides centralized dashboards combining clinical data, safety signals, and event tracking across global CVRM programs
- Helps quickly identify and review cardiovascular and metabolic events for safety monitoring and interim analysis
- Delivers structured, submission-ready datasets aligned with regulatory expectations for FDA, EMA, and global authorities
Imaging, biomarkers, and digital data integration
- Incorporates cardiovascular and renal imaging data such as echocardiography, CT, MRI, and renal ultrasound alongside clinical and laboratory datasets
- Links cardiometabolic biomarkers including lipids, glycemic markers, and renal function with outcomes and safety monitoring
- Integrates data from digital health technologies and remote monitoring tools to provide a comprehensive view of patient status over time
Designed to support large-scale, longitudinal CVRM studies focused on outcomes such as cardiovascular events, renal decline, and metabolic progression
Built on a unified data architecture that connects clinical, operational, and real-world data across extended study timelines
Flexible configuration enables protocols to adapt to evolving endpoints, clinical guidelines, and regulatory expectations without system rework
Simplifies collaboration across sites, sponsors, CROs, and data vendors in complex, multi-country CVRM programs
Replaces fragmented systems with a single coordinated environment, reducing operational burden and improving data consistency
VALUE PROPOSITION
Why sponsors choose oomnia for CVRM 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 CVRM trials
oomnia delivers a compliance-aligned data environment tailored to the demands of cardiovascular, renal, and metabolic research, supporting complex, long-duration studies and diverse data sources
21 CFR Part 11–compliant records
21 CFR Part 11–compliant records with complete audit trails and secure electronic signatures to ensure data integrity across extended CVRM trial timelines
Risk-Based Quality Management
Risk-based quality management (ICH E6(R3)) embedded into everyday study operations, supporting continuous oversight in large, event-driven CVRM trials
CDISC-compliant data standards
CDISC-compliant data standards, including CDASH for data collection and SDTM-ready outputs for streamlined analysis and submission across CVRM programs
Global regulatory support
Designed to support regulatory submissions to FDA, EMA, and global authorities across multinational cardiovascular, renal, and metabolic programs
Get Started
Advance your next CVRM study with clarity
Bring clinical, imaging, laboratory, and real-world data into one unified environment to improve oversight, reduce operational complexity, and support efficient execution across global CVRM programs
Talk to our team