Top 15 Pharma Selects elluminate to Support Digital Clinical Initiative

A large pharmaceutical company is developing a next generation clinical data architecture to support their digital health objectives, and elluminate® is a key platform.

Challenge

A large pharmaceutical company needed a system to support their next generation clinical data architecture. The goal of the platform is to support the digital health objectives of the business, which are to identify promising targets faster, accelerate clinical trials, and develop new evidence-based models demonstrating value of developed products.

Solution

The primary objective of the new architecture is to deliver an integrated clinical data platform that will streamline access to clinical data to deliver better insights and improve data driven decision-making for use by clinical operations, data management and clinical programming.

Results

In the new architecture, elluminate provides streamlined, governed access to a broad set of clinical data. elluminate will be used for data ingestion, transformation, aggregation, and analysis. Implementation is currently underway and new trials plan to begin using the new integrated architecture in the fall of 2019.

Background

The Clinical Development organization and IT business partners of a large pharmaceutical company are developing a next generation clinical data architecture. The overall goal of the platform is to support the digital health objectives of the business which include identifying promising targets faster, accelerating and advancing clinical trials and developing new evidence-based models that demonstrate value of developed products. The project is being sponsored by executive R&D and IT leadership with key stakeholders from global clinical operations, clinical programming, data management and IT and includes a systems integrator that is helping to define and implement all pieces of the new architecture. The primary objective of the new architecture is to deliver an integrated clinical data platform that will streamline access to clinical data to deliver better insights and improve data driven decision-making for use by clinical operations, data management and clinical programming.

Project Components

The new architecture includes the following components:

  • Metadata Repository & Standards Management: Manage data standards across all phases of research
  • Clinical Data Hub (elluminate): Review, aggregate, analyze and curate data
  • Clinical Data Repository: Data from the CDR is accessed from statistical computing environment for analysis
  • Enterprise Data Lake: An enterprise data lake is being built to include genomics and other real-world data sources
Role of the elluminate Platform

In the new architecture, elluminate provides streamlined, governed access to a broad set of clinical data. elluminate will be used for data ingestion, transformation, aggregation, and analysis, enabling insights to advance clinical development. Key components of the elluminate implementation include:

  • Consume data from the Metadata Repository, Rave and other 3rd party applications
  • Review, and curate clinical data via elluminate Data Central, Mapper and Analytics
  • elluminate Analytics used by clinical operations and data management, replacing existing operational and clinical analytics built internally
  • elluminate APIs used to export data into the Enterprise Data Lake ecosystem, which is being built internally via external APIs.
Implementation Process

eClinical Solutions is providing a set of implementation and training services along with data configuration and mapping for the first set of studies to facilitate the initial implementation, rollout and adoption. These include:

  • Formal training courses for role-based end user training on Data Central, Mapper and Analytics
  • Implementation consulting via subject matter experts who align business objectives to the tools and functionality and identify elluminate best practices by role and function
  • Enablement training for the client team to use Mapper to configure and map data within elluminate for future trials

The implementation process is currently underway. New trials plan to begin using the new integrated architecture in the fall of 2019.

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