Centralize and simplify data review and management
Fact Sheet
30-minute intro to elluminate Data Central
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Integrated data review and management — from any data source
elluminate® Data Central brings together all of the data associated with your trial into a single, central system for clinical data management and review — from any data source.
AI-enabled Data Review with eIQ Review
Seamlessly integrated with Data Central, eIQ Review provides AI-enabled review capabilities for data managers and reviewers to ensure data integrity in a more efficient, scalable way. With AI-enabled data review capabilities, you can improve data quality, increase the speed of review, and reduce manual efforts.
eIQ Review
Save Time with Integrated Data Review
With Data Central, data managers and medical reviewers collaborate within the clinical data management software to quickly and effectively manage study data and resolve queries and other data issues. Produce a high-quality database using in-stream data review – without having to access multiple disparate systems, spreadsheets and listings.
- Raise and process EDC queries directly in Data Central
- Review CRF data, listings, exception reports, and patient profiles
- Quickly identify data changed since the last review by role, to flag for re-review
Improve Data Quality with Actionable Analytics
Data Central analytics facilitate targeted data reviews based on roles and automatically highlight areas needing attention, such as long-outstanding queries. Analytics in one centralized clinical data review and management system eliminates the need to create and distribute multiple data exports, reducing the risk of introducing errors.
- Drill down to source data and raise issues directly from within the visualization
- Create and access customizable graphical patient profiles including single and ongoing events, lab data, etc.
- Focus on the right data for the tasks, not on assembling data sources
Role-Based Review to Manage Data More Effectively
Data Central gives teams one role-based clinical data management system for integrated data review. A holistic view of the study for data, query, and issue statuses provides you with earlier insight into potential areas to address, so you can be proactive and data-driven.
- Review data and listings according to role in the clinical data management software
- Track records that have been reviewed by role and records updated since last review
- Monitor and track issues by due date, assignee, site, subject, data domain and more
elluminate helps me focus more on strategy and less on the piece by piece data review, so I can look at the bigger picture. It also helps build better relationships within my company because I can provide the medical group and the safety group with what they need quickly and make sure that it’s accurate.
Elizabeth ThompsonAssociate Director, Clinical Data Management, Sarepta Therapeutics
FAQ
What is elluminate Data Central?
Data Central is a module within the elluminate Clinical Data Cloud that provides users with access to real-time clinical data from numerous sources. This centralized access provides greater visibility into data, and allows for faster, more efficient data management and data review processes. Users can access robust pre-programmed listings, patient profiles, visualizations, and review, add, or address issues and generate queries. Once reviewed, data does not show again unless it has been changed or new data added – streamlining the review process.
How quickly can Data Central be deployed?
The initial configuration of Data Central can be completed within a matter of days. Some features such as graphical patient profiles or exception listings can take additional time to populate, but no longer than a matter of weeks.
Will Data Central work with my existing clinical data infrastructure?
The elluminate clinical data cloud is system agnostic, and therefore capable of ingesting and aggregating data from any source regardless of file type or system. Data Central can expose raw and standardized data for review.
Is Data Central easy to use?
Yes, Data Central is designed to be user friendly and easy to adopt. In addition, the system removes burdensome manual efforts & guesswork, improving user experience. Using this module allows for rapid review of critical data instead of trying to sift through and find problem areas.
How often can the data be refreshed?
Data refreshes are completely configurable within Data Central. Users can also export data on an ad hoc basis depending on system permissions through elluminate.
Can users mark and/or comment on records or listings?
Yes, users can mark and/or comment on listings depending on system permissions. Additionally, listings created within Data Central can be configured to require review from a particular user, role, or number of users. Comments and queries are visible to other users, preventing duplicate efforts.
Who in my organization benefits from Data Central?
elluminate Data Central provides a wealth of benefits to numerous roles, including data managers, medical monitors, clinical scientists, and clinical operations. Additionally, Data Central benefits both insourced and outsourced models, allowing for more efficient resource and personnel management and greater oversight of CRO or third-party activities.
Are patient profiles available within Data Central?
Yes, graphical and Excel-based patient profiles are immediately available to users following initial configuration. Additionally, users can create graphical patient profiles for their own use or to share with team members.
Are all actions within Data Central captured in an audit trail?
Yes, elluminate is fully compliant with 21CFR Part 11 and ensures data privacy and security in accordance with global regulatory requirements. Applicable reports can be accessed within the system or exported for inclusion within trial master files or other documentation.
