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Leveraging an Integrated SCE to Streamline Digital Trials

Demonstrating rigor in the analysis and reporting of clinical trial results requires transparency, reproducibility, and adequate documentation. With the increasing amount of clinical data available, more sophisticated methods, and an emergence of data science techniques, a high-performance computing environment is necessary in order to produce accurate and consistent results in support of regulatory submissions.

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OP RA T I O E NAL DATA REPOSITORY CLINICAL DATA REP O S I TORY

METADATA REPOSITORY

More companies are considering leveraging an e-clinical platform as they optimize and modernize their analytics and infrastructure strategy. Gartner defines an e-clinical platform as “an integrated suite of technologies connected to a platform architecture that provides services and solutions to manage clinical trial planning and execution”. 4 Utilizing a Statistical Computing Environment within an e-clinical platform that provides access to metadata, clinical data, and operational data can provide even greater benefits for programmers and statisticians. With access to these key elements, data, standards, and mappings can be leveraged for maximum reuse and increased programming and analysis efficiencies.

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