is the Foundation of Digital Trials
All your data – from any data source – in one platform. Modernize & automate your digital data flow.
Streamline your end-to-end clinical data workflow with the elluminate Clinical Data Cloud
eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate® Clinical Data Cloud — the foundation of digital trials. Leveraged by 100+ biopharmaceutical companies, elluminate is a purpose-built clinical data cloud designed to accelerate digitization efforts in order to proactively manage the exponential growth of clinical data volume, variety, and velocity.
Delivering Value at Scale
According to Gartner’s 2022 Hype Cycle for Life Science Clinical Development, life science companies continue to accelerate scaling digital capabilities and the adoption of hyperautomation, AI and advanced analytics is becoming mainstream. With elluminate’s automated data pipeline and scalable infrastructure organizations are able to keep up with the complexities of modern clinical trials to deliver business value across clinical development functions.
elluminate delivers benefits to clients of all sizes. Leveraging the elluminate Clinical Data Cloud as the foundation for your digital clinical trials enables you to:
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 with Rave and other systems allows faster integration of new data sources for more efficient data review and cleaning. Built in automation, standardization & interoperability allows your data to work for you, right from the start. Clients see positive impact on cycle time metrics including LPLV to DBL and LPLV to data set analysis.
A unified end-user experience with integrated data review capabilities enables faster decision making with easy-to-use analytics, workflow, and issue management – all in one place. 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, automation and study agnostic ML approach supports rapid AI enablement across the platform. With expanding AI capabilities, clinical teams have the ability to transform data into intelligent decisions faster -keeping up with the speed of science – without sacrificing quality.
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. Modern data pipeline, automation, and study agnostic ML approach supports rapid AI enablement across the platform.
Clinical Data Repository
Operational Data Repository
Powerful data transformation, unification and automation from diverse data sources and formats without programming for submission and analytic needs.
All your trial data from every source, one place for integrated review- listings, patient profiles, analytics, queries and issue management.
Comprehensive visualizations and reporting that support safety and efficacy decisions within and across trials, operational analytics that help proactively manage your trial.
Manages and combines all your operational data into one source of truth that you can benefit from for both your ongoing and future trials.
Transform numerous data streams into actionable analytics and statistically significant insights for a more focused, data-driven monitoring effort that enables active oversight and ensures trial compliance.
Produce submission or exploratory analysis outputs – within and across studies – in a way that is transparent, auditable, automated, reproducible and secure.
Pervasive AI & machine learning to automate manual processes and deliver faster insights.
Manage samples in real-time for more effective trial oversight.
elluminate for Every Team
Clinical Data Management
elluminate helps me focus on strategy so I can look at the bigger picture.
We’re seeing ROI because we’re able to do a lot of programming in-house.
Our ability to now track samples helps us make real time decisions.
Recognize Value Faster
Establish a firm foundation for your digital trials rapidly – with out of the box data connectors use cases and implementation accelerators for every function
One Foundation Across All Functions
eClinical’s elluminate Clinical Data Cloud and Biometrics Services empower and inform stakeholders across the organization.
For Data Management
For Clinical Operations
For Medical Monitoring
For R&D IT
For Clinical Programming
Automate processes for clinical data integration and standardization from disparate sources, for streamlined publishing, exploration, and analysis.
I don’t know how you could run today’s trials without elluminate.
Director of Clinical Informatics
Praxis Precision Medicines
Automating the Data Transformation Process
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.
- Drag-and-drop interface for non-programmers
- Dynamic templates that map data upon import
- Automated standards checking and full compliance, including audit trails
Comprehensive Data Review
elluminate Data Central brings together all the data associated with your clinical trial into one integrated platform for data review and management — from any data source. Data managers and medical reviewers can collaborate to quickly and effectively manage study data, resolve queries and track data issues. The results are high-quality databases for analyses and submissions.
- Integrated data review from all sources
- Actionable analytics software supporting review, e.g., patient profiles, medical data analysis
- Role-based reviews, workflow and issue tracking
Meaningful Analytics that Accelerate Timelines
All your data in one platform means you have analytics that answer all your questions, without requiring your teams to check other sources. The result is accelerated timelines, faster insights and rapid identification of data issues.
- 40+ out-of-the-box analytics
- Visualizations designed to support data management, clinical operations, and medical review/safety
- Self-service access to all study data and ad-hoc analytics
- Guided Data Story and snapshot creation
- Operational metrics and predictive insights
Manage Your Trial Operations with a Data-driven Approach
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, enabling clinical teams to leverage all data for other data-driven applications.
- 20+ trial operational visualizations and instant insights about enrollment, data quality at sites and visit timelines with CTOA
- Automatically integrate and harmonize all operational data from CRO managed studies and other sources in a single location for increased visibility across the development portfolio with Operational Analytics
- Track samples in real-time to proactively identify issues and mitigate potential roadblocks with Sample Management Analytics
Risk-Based Quality Management
Proactively Manage Risk
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 improves the compliance of a clinical trial. Integrated with Data Central, elluminate RBQM proactively identifies potential issues the moment they arise, ensuring study data quality and integrity from start to finish. elluminate RBQM provides:
- A holistic view of risk across all trial data sources with visualizations and interactive dashboards that show risk at the site and country level
- The ability to define and track Quality Tolerance Limits (QTLs) within a study
- Predictive modeling for KRIs and QTLs using both advanced statistical modeling and AI / ML frameworks
- Advanced data management workbench capabilities supporting data management, clinical operations, and data science functions
Statistical Computing Environment (SCE)
Accelerate & Automate Statistical Analyses
The elluminate Statistical Computing Environment (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. Produce submission or exploratory analysis outputs – within and across clinical studies – in a way that is transparent, auditable, automated, and reproducible.
- Work seamlessly with existing raw and mapped data stores
- Access data and metadata across studies
- Set programs to execute automatically upon updates to data
- Assign tasks and track programming lifecycle within the system
- Version control of programs and audited traceability of executions & results
- Integrated compute environments for SAS, R, and Python
Automated Integrations with All Your Data Sources
Easily integrate with your existing data sources
elluminate provides automated integrations out of the box with the Medidata Clinical Cloud and numerous other MDR, EDC, eCOA, Lab and IVRS systems. Flexible APIs and Web Services enable easy data ingestion and extraction to other data environments.
- Data import from any source and format
- Two way integration with Medidata Clinical Cloud
- Import source data automation for standardization and consistency
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 platform, 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 50 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 Solutions Data Services team user elluminate across all client trials. elluminate is designed for maximum ease of use by clinical teams.
elluminate clients regain control & unlock the value of their clinical data
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Clinical Data Cloud is the Foundation of Digital Trials
All your data – from DCTs, EDC, labs and CROs' CTMS – your way. Modernize & automate your digital data flow from collection through submission.
is the Foundation of Digital Trials
All your data – from any data source – in one platform. Modernize & automate your digital data flow.
Ready to take charge of your clinical data?
Schedule a demo and/or speak to an eClinical Solutions representative to learn more.