Building a Future-Proof Clinical Data Infrastructure Case Study
PROJECT BACKGROUND
In the wake of a recent acquisition, a growthminded, global biopharmaceutical company saw the need to evolve its clinical data infrastructure. To meet the data requirements of current and future studies - studies that would be more complex with an increasing volume of data being collected from a multitude of widely varying sources - they knew they needed to establish a new data culture. This vision meant moving on from inefficient, resource-intensive legacy processes to a more intuitive, modern, flexible, and technology-driven approach to clinical data management.
THE CHALLENGE
In the context of their rapid growth, the biopharmaceutical company developed a clear understanding of what they required from a new clinical data and analytics platform. At heart was the need for a robust overarching clinical data strategy that would maximize the value of their data. To achieve this, they needed a solution that would deliver better, deeper insights from the data with the flexibility to accommodate yet-unknown future needs. In tandem, they aimed to offer their platform users new ways to visualize data that would allow them to access and analyze
COMPANY PROFILE
■ Global, Mid-sized BioPharma
■ ~ $2 Billion+ in Revenue
■ ~ 1,200+ Employees
PRODUCTS
■ Mapper
■ Clinical Analytics
■ Data Central
■ Risk-based Quality Management (RBQM)
information more quickly and easily. Further, they needed on-demand access to data from CROs (Contract Research Organizations), labs, and other sources, as well as visibility into metrics and performance, which would give them greater overall control.
Finally, they wanted this new solution to drive greater efficiency and cost savings through process improvements and task automation, while establishing a solid foundation for future applications of advanced analytics.
THE SOLUTION: A Single Platform Solution for All Studies – Today and in the Future
The company sought a technology partner that could address its current needs while providing a foundation with additional capabilities embedded that could be leveraged as the organization continued to grow over time. Having evaluated various solutions, the client chose to work with eClinical Solutions and implement the elluminate Clinical Data Cloud® in 2020, specifically leveraging Mapper, Clinical Analytics, and Data Central at that time.
The elluminate platform provided the ability to consolidate a variety of data types from multiple
RESULTS
sources and systems into a centralized location. Having a single repository for all study data ensured stakeholders had access to the most current data, in near real-time. Additionally, through the implementation of elluminate, the team no longer had to manage system interoperability issues and were able to unlock greater efficiencies through automation and reuse of existing data sets.
The platform approach has enabled numerous cross-functional process improvements resulting in significant resource efficiencies and cost savings since implementation.
Since adopting elluminate in 2020, the biopharmaceutical company has used the platform for 40 studies. Over the past three years, they have seen numerous positive results, including:
■ Reduction in time required to monitor data quality, reducing clinical trial cycle times.
■ Improved internal resource utilization as the time required by internal teams to transform and standardize data decreased.
■ Faster identification of potential issues using dashboards and usage metrics to identify areas in most need of attention.
■ Reduced study closeout efforts by 3-4 weeks per study by leveraging the platform capabilities that enable more proactive data review, query handling, and issue management.
■ Achieved a 7-day DBL as a part of their 2024 initiative.
■ Saved on combined FTE employees by streamlining programming requests, creating consistent workflows, and by utilizing elluminate’s advanced data review capabilities.
Through its use of elluminate, the biopharmaceutical company now has the clinical data and analytics infrastructure it needs to meet the demands of its existing clinical research pipeline and a scalable foundation for more complex global clinical trials in the years ahead.
Today, the company continues to find additional ways to expand its use of elluminate and maximize its value, supported by the ongoing Product Development and collaboration with the eClinical Solutions team. For example, the rapid success of the elluminate implementation and the value realized by having a single, central data repository, led the company to expand and deploy elluminate’s Risk-based Quality Management (RBQM) solution to further drive efficiency and reduce risks and associated costs.
For more information on elluminate Clinical Data Cloud®, visit eclinicalsol.com | Or email us at: info@eclinicalsol.com