While designing clinical studies, it is essential to plan and implement an effective and efficient centralized coding process and system, in order to detect and analyze evolving signals that will help companies manage and mitigate any safety concerns, early in the development stage.
PACE Clinical is designed to work as part of any adaptive trial process. As the terms are being coded, the inbuilt analytics at each stage of coding assists the coder and reviewer to understand the evolving safety profile of the investigational drug.
The Multi-Dictionary Version Flexibility of PACE allows different studies to be associated to different versions of dictionaries, per the design and requirement.
The built-in configurable, role based workflow and automated data movement help ensure consistency and quality.
Recoding could become challenging due to the size and type of data to be recoded. New dictionary versions often impact ongoing process. PACE central auto-coding engine makes it easier and faster to recode data as required. PACE allows coding of terms in batches thus increasing throughput and productivity. Assisted by the comprehensive impact analysis feature, the user would always know the impact before any change is applied.
PACE provides the facility to export the coded data in XML / ASCII format, so the processed information could be imported into any Clinical or Safety Database or into statistical tool for further analysis.
