eClinical Overview Fact Sheet

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eClinical Solutions

The elluminate® Clinical Data Cloud the foundation of digital trials provides a central location for all clinical and operational data. The result is a single source of truth across all data sources — from ingestion to insights. Out of the box data connectors, built-in automation, advanced analytics, and self-service access to data from a single location allows value to be recognized faster and enables smarter decision making throughout the trial lifecycle. Used by more than 100 life sciences companies, including 10 of the top 30, elluminate streamlines end-to-end clinical data workflows for more efficient digital clinical trials.

elluminate Products

■ Data Central Single, integrated application for comprehensive datareview and management from any data source. Provides users with self-service access to clinical data and to identify and track issues using visualizations and listings.

■ Clinical Analytics Powerful clinical and operational visualizations for use by Clinical Operations, Data Management, Medical and Safety along with the ability to build ad-hoc visualizations.

■ Mapper Unique application with a drag-and-drop interface allowing nonprogrammers to rapidly set up connections to numerous data sources, perform complex data transformations to SDTM and other standard formats, and publish curated data for analytics.

■ Risk-Based Quality Management Monitor risk across all trial data sources from a single platform for a more focused, data-driven monitoring effort that enables active oversight and improves trial compliance.

■ Operational Insights Combines all your operational data into one source of truth, for proactive management of trials and risks across the portfolio.

■ Statistical Computing Environment A validated environment for the production of submission or exploratory analysis outputs in a way that is transparent, auditable, automated, reproducible, and secure.

■ elluminate IQ Advanced AI and ML capabilities add to the depth and breadth of elluminate’s data-driven products to deliver transformational value and accelerate complex decision-making throughout the clinical trial lifecycle.

Company Fast Facts

■ Founded in 2012, headquarters in Boston, MA, offices in Europe and India

■ 400+ team members

■ Offerings: elluminate Clinical Data Cloud & Biometrics Services

■ Experience: 100+ Clients, 2000+ elluminate users

■ Medidata accredited partner with 8 Medidata certifications and in-depth experience across all Medidata products

■ Deep therapeutic area expertise in Oncology, Immuno-Oncology and Rare Disease

Fact Sheet

Biometrics Services

Biometrics Services help companies succeed and scale by providing increased data access, standardization and control. The combination of the Medidata Rave Clinical Cloud for data acquisition and the elluminate Clinical Data Cloud delivers modern, agile data management. The eClinical professional services team ensures your project has the highest quality and regulatory-compliant clinical data deliverables, from acquisition through submission.

Data Management Services

■ Data acquisition services include high quality database builds and libraries using Medidata Rave Clinical Cloud

■ Quality-driven data review and management from FPI through lock, for faster submission preparation

■ Optimized data review, metrics, and analytics through elluminate

Biostatistics & Programming

■ Strategic statistical input and programming including submission-ready SDTM and ADaM deliverables

■ Statistical analysis plan preparation including Mock TLFs

■ TLF generation for Interim Analysis/Final Analysis/DSMBs comprehensive ISS, ISE services

Data Management Functional Service Provider

■ Flexible FSP model provides an expert team of dedicated clinical data management professionals who are an extension of the sponsor—maximizing quality while reducing costs

■ Design and build of client data standards, SOPs and libraries

■ Powered by elluminate and Medidata Rave Clinical Cloud to deliver best-in-class technology enabled services

Learn More

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert biometrics services and the elluminate Clinical Data Cloud—the foundation of digital trials. Together, the elluminate platform and biometrics services give clients self-service access to all their data from one centralized location; plus, advanced analytics that help them make smarter, faster business decisions.

For more information or to request a demonstration, visit us at: eclinicalsol.com

Or email us at: info@eclinicalsol.com

Fact sheet – eClinical Solutions T: 877-355-8668 (877-ELLUMN8) eclinicalsol.com ©2023 eClinical Solutions LLC. All rights reserved. elluminate® is a registered service mark of eClinical Solutions LLC.
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