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The Foundation of Digital Trials

agios
blue bird bio
bristol myers squibb logo
cerevel logo
sarepta
agios
blue bird bio
bristol myers squibb logo
cerevel logo
sarepta

Platform Benefits

Democratize Your Data

Optimize data flow by eliminating silos and multiple systems for data review and downstream data delivery. The eradication of silos and real-time access to data across clinical teams facilitates cross functional collaboration and more efficient, data-driven decision making.

Accelerate Cycle Timelines

Existing APIs & bi-directional interoperability allows faster integration of new data sources for more efficient data review and downstream analyses. Built in automation, standardization & interoperability allows your data to work for you, right from the start.

Increase Productivity

A unified end-user experience with integrated data review capabilities, easy-to-use analytics, workflow, and issue management enables faster decision making.. A one-stop-shop for all your clinical data management & analytics needs – from ingestion through submission – increasing speed & efficiency of your trial.

Future Proof Your Trial

elluminate’s modern data pipeline, built-in automation, and study agnostic ML approach supports rapid AI enablement across the platform. With expanding AI capabilities, clinical teams can transform data into intelligent decisions faster and support tomorrow’s breakthroughs with today’s resources.

PRODUCTS

Build a Strong Foundation for Your Digital Trials

Three integrated repositories to reduce data silos and speed the time to insight while supporting data quality, transparency, and audit readiness. A modern data pipeline, automation, and study agnostic ML approach supports rapid AI enablement across the platform.

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data central icon
eIQ Review
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operational insights
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Mapper

With elluminate Mapper, users perform complex transformations through a visual interface, turning disparate data streams into submission-ready CDISC SDTM and analysis datasets. SDTM and reporting transformations can be accomplished by less technical resources and data can be explored, combined, curated and published.

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Data Central

elluminate Data Central integrates all your clinical trial data – from all sources – into a single platform for data review and management. Clinical teams can collaborate to quickly and effectively manage study data, resolve queries, and track data issues – resulting in high-quality databases for analyses and submissions.

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eIQ Review

With the AI-enabled data review capabilities available in eIQ Review, data review processes are transformed, enabling data management teams to conduct clinical data review in a more efficient, scalable way.

eIQ Review

Clinical Analytics

Comprehensive visualizations and reporting that support safety and efficacy decisions, and operational analytics that help proactively manage your trial.

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Operational Insights

elluminate Operational Insights centralizes all your trial operations data and offers built-in automation and analytics to enable greater trial efficiency and proactive oversight. This platform-based approach eliminates the need to maintain siloed repositories for clinical and operational data, increasing visibility across your development portfolio.

operational insights

Risk-Based Quality Management

elluminate RBQM provides clinical teams with a single platform for all study data sources to support a more focused, data-driven monitoring effort that enables active oversight and trial compliance. elluminate RBQM proactively identifies potential issues, ensuring data quality and integrity throughout your trial.

Statistical Computing Environment (SCE)

elluminate SCE provides a validated environment for demonstrating rigor in statistical analysis and reporting. Unlike other cloud computing environments, elluminate SCE provides one centralized place for all your data, metadata, programs, and results – increasing the efficiency, traceability, and visibility of your statistical analyses.

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Sample Management Analytics

Sample Management Analytics enables you to track all of your trial samples from a single platform. With built in automation for data reconciliation, sample journey visualizations, and statistical reports, Sample Management Analytics enables you to track samples in real-time to proactively identify issues and mitigate potential roadblocks.

FAQ

How does pricing work?

elluminate is a cost-effective SAAS product and typically includes a monthly user license fee, support and an initial implementation and setup fee. There is a comprehensive set of training courses included along with 24×7 end user support. elluminate delivers value to clients by providing increased control over, and direct access to, all of the data from disparate sources being collected in clinical trials. End users who were formerly disintermediated from their data and had to rely on clinical programming teams for high quality analyses and reporting gain self-service access to curated data sets, saving both time and money. A detailed ROI model is available demonstrating how elluminate saves costs based on the products utilized and the number of ongoing and archived studies included.

Is the elluminate platform self-service?

The elluminate platform is dedicated to providing clinical researchers with self-service access to their data and self-service is one of the key themes used to govern elluminate product development prioritization. In Analytics, end users can copy and save worksheets to explore data and even create their own app from a variety of different data sources, according to their permissions. elluminate enables clients to determine the types of data access and permissions that are provided to different types of users, roles and groups to ensure the organization’s optimal level of self-service access to different data stores and analytics.

Will this work with my existing clinical data systems?

elluminate is a flexible platform that fits within existing clinical technology ecosystems. As a clinical data cloud, elluminate is designed for rapid data integration. elluminate gracefully coexists with many other eclinical platforms and has an out of the box, two-way integration with the Medidata Clinical Cloud. Data from many other systems including MDR, EDC, safety, eCOA, IVR, Labs, Omics, Biomarkers, eSource and physiological sensors have been successfully integrated into elluminate. Clients can also leverage elluminate for external data sources and combine that with EDC data for analytics and review, as well as data exploration and curation via Mapper. Hear how elluminate fit into Bristol-Meyers Squibb’s technology ecosystem in this brief video.

Is the elluminate Clinical Data Cloud compliant and secure?

elluminate is fully compliant with 21CFR Part 11 and ensures data privacy and security in accordance with global regulatory requirements. elluminate has a flexible permission architecture allowing limited access to certain types of data as required per client SOP. As a proven system in use for clinical data since 2012, elluminate has been used to prepare data for numerous regulatory submissions that have received approval across therapeutic areas.

Is my organization able to get immediate value out of this?

Yes. As a cloud based system, elluminate can be deployed rapidly to ensure maximum value. The typical implementation and rollout takes a phased approach by identifying key value drivers elluminate can deliver for specific roles and functions, and implementing the platform to those groups while measuring success and satisfaction in the process. The goal of the elluminate delivery team is ensuring clinical teams achieve their business goals with high volume and adoption in the least amount of time.

How long will implementation take?

elluminate’s cloud-based products are designed for rapid implementation. A typical elluminate implementation takes 90 days which may include putting archived, new or ongoing studies into the hub. The implementation process includes defining the key value drivers of the system for the client, the data sources that will be included, and preparing and standardizing data. elluminate includes a validation accelerator package that provides a risk-based approach, as well as test scripts and documentation to facilitate the internal validation process. Implementation consultants guide client teams through the process, focusing on the capabilities that will maximize value to client stakeholder groups. End users are fully trained and prepared for elluminate adoption and rollout.

Is elluminate easy to use?

elluminate is easy to use and is designed with the workflow of data management, clinical operations, and medical review of biostatistics in mind. The primary objective of elluminate Mapper is to make data integration and mapping easier for non-programmers. Data Central is designed for significantly more efficient and automated data review by data managers and medical monitors. The visualizations in elluminate Clinical Analytics are intuitive and flexible, linking to issue workflow so teams can act upon data insights in real-time. The eClinical Solutions professional services team uses elluminate on every engagement to deliver high quality data services to clients, and internal power users provide continuous feedback and suggestions so that enhancements always have end user goals in mind. elluminate includes role-based training guides and videos along with best practices to ensure users are up to speed quickly.

Is elluminate proven?

elluminate is a proven platform that has been used by Life Sciences companies since 2012. Currently, more than 100 clinical development organizations of all sizes rely on elluminate to regain control of their clinical trial data. Critical data assets across thousands of studies are currently being stored in the elluminate platform for both ongoing and archived studies, providing researchers with new clinical and operational insights. Studies using elluminate for clinical data review, management and analysis have been submitted to regulatory authorities and approved, and SDTM data that was produced with elluminate Mapper has been used for FDA submission.

How does the elluminate Clinical Data Cloud scale?

elluminate scales effectively and leverages cloud-based processing power to ensure high performance for users independent of the volume of studies or the number of users accessing the system. elluminate uses a modern technology stack to ensure users experience optimized performance and visibility to their clinical data at all times.

Who in my organization benefits from this platform?

End users from Clinical Operations, Data Management, Medical Monitoring, Biostatistics and Clinical Programming enjoy working in elluminate as it provides them with immediate value, time savings and streamlined workflows. elluminate provides clinical teams with one source of truth from which to work, eliminating the need for numerous excel trackers that tell different stories and require rework and reconciliation. The eClinical Biometrics Services team uses elluminate across all client trials. elluminate is designed for maximum ease of use by clinical teams.