oomnia EDC

Optimized Electronic Data Capture for clinical research trials

software (2)

Effective and efficient trial management. Your way

oomnia EDC is a unique, fully digitized solution for collecting, cleaning, and reviewing clinical trial data. The data integration capabilities, customized dashboards, and real-time reports enable you to oversee and manage your clinical trial effectively and efficiently.

oomnia EDC is designed to support the process of clinical trials throughout their lifecycle. Paired with oomnia’s other features, our EDC module provides you with a flexible, versatile, integrated, role-specific and accessible platform with customized dashboards per role to facilitate clinical trial data and operational oversight.

Benefits

Interoperability

Data interoperability allows seamless data exchange and automated cleaning, reducing redundant and error-prone actions.

Reusability

Reuse eCRF templates, roles, settings, and variables easily across multiple trials.

Real-Time Reports

Customized downloadable reports and email notifications.

Solutions

Cloud Database

Cloud-based EDC ecosystem creates synergies along the entire clinical trial life cycle. All data is stored in a centralized cloud database, with the capability to create separate, secure country- and region-specific cloud databases to comply with local data sharing regulations.

Intrinsic and Extrinsic Integration

Data integration across designated eCRFs reduces duplicate data entry, and integration of external data within EDC further facilitates study oversight, automated data cleaning, and reconciliations.

Alignment with CDISC standards

The EDC module is designed with pre-programmed data collection groups based on CDISC standards, allowing each eCRF to be fully customized per eCRF page using a drag-and-drop functionality aligning with CDISC standardization.

Increased efficiency across Users

Capability for single sign-on access to all assigned trials within EDC, with the flexibility to use the previously defined User Roles or to create new study-specific definitions. Template User Role definitions can easily be updated per eCRF page, in addition to corresponding report and dashboard templates per User Role.

Features

Group 271

Star icon Integration

oomnia’s EDC integration engine is capable of integrating data from various sources, including but not limited to: electronic health records, medical device data (including wearables), central and local laboratories, ePRO, drug assignment and accountability.

Star icon Customized Reports and Dashboards

Standard template reports can easily be customized to meet Client and User needs per study. New reports can also be created to incorporate additional data or to present the data in different outlays to facilitate study oversight, monitoring, and reporting. Dashboards are created to be User-specific, providing the most critical study status updates upon sign-on.

Star icon SAE Reporting

Designated eCRFs can be utilized to capture Initial, Follow-Up, and Final SAE Reports directly within EDC.

Star icon Automated Data Cleaning

Our technology includes advanced edit checks during data entry and across eCRF pages. Each eCRF will only display the required data fields when applicable based on data entries for previous fields.

Star icon User Roles

User roles are defined for each study, with granular access and privilege settings that can be applied to any EDC document or tool. These Role settings can be saved and reused in the future, or they can be redefined.

Star icon Intuitive, User-Centered Design

Intuitive user-centric design minimizes requirements for training and support requests, facilitates faster data entry and data cleaning, and reduces overall time spent on data capture efforts. Our EDC solution is designed with the end user in mind. Therefore, we paid particular attention to efficiency, effectiveness, error tolerance, and ease of learning. As a result, users are provided with a more manageable data capture process, with fewer queries and redundancies.

Star icon Audit Trails

Our audit trails are visible within each eCRF. The Data Manager can also export the audit trails in various file formats, which are easily understood for study team members, but also suitable for computed analytics.

Generate prolific insights from your clinical trials with a truly interoperable platform.

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