Case Study
Simplifying external data management for complex rare disease trials with people, process, and technology BACKGROUND Our client is a biotechnology company headquartered in the USA creating novel therapeutics for rare diseases. They have a portfolio of early phase studies investigating their innovative product for an area of high unmet patient need. In rare diseases, every data point counts, so the biotechnology client approached eClinical Solutions to support their biometrics services and execute an end-to-end data strategy from EDC (Electronic Data Capture) implementation to statistical analysis and reporting. While these projects have many unique challenges across the data life cycle, for this case study we focus on the specific challenges the client faced in handling the external data volume and variety characteristic of increasingly complex trials. We will explore the solutions that eClinical Solutions put in place through its Biometrics Services, Center of Excellence for External Data, and the elluminate Clinical Data Cloud®, and highlight efficiencies achieved working across several studies.
THE CHALLENGE OF EXTERNAL DATA With ongoing technology advances and an increase in overall research complexity, trials are now incorporating an ever-increasing variety of data types and sources collected outside of traditional electronic data capture (EDC) systems. This volume and variety, combined with growing data velocity, brings transformational opportunities for richer patient insights, and more efficient clinical development. However, a proliferation of external data brings accompanying challenges of standardization, reconciliation, and more complex vendor collaborations. In the face of this continual change, it is important to take a strategic approach to collecting, processing, and managing external data, and avoid bottlenecks that risk delays to Last Patient Last Visit (LPLV) to database lock cycle times.