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Case Studies

Streamline your clinical data processes and explore your data. If you are facing a complex data management process requiring specialized knowledge in data models, database design, and clinical data science, then contact us today!

Blinded Independent Review Committee for Observational Trial

To facilitate Blind Independent Central Review (BICR) in an observational trial, legacy scans must be appended to patient profiles and serve as a synthetic control arm. The images were received in a SharePoint directory, which provided permissioned access to authorized members. Our team automated the process of retrieving the images and generating patient profiles so that the reports could be made available soon after the latest data and images arrived.

Upversion Macros for New Standards

With the upcoming FDA standards catalog update, ensuring our SDTM macros align with the new standards is crucial. We've implemented a comprehensive framework for reviewing existing macros, pinpointing necessary updates, and conducting detailed testing to ensure compliance. Our team is committed to preserving data integrity and facilitating a smooth transition.

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Database Migration and Medical Review

By integrating various software tools such as Oracle, SAS, and JReview, we established a pipeline for data cleaning, standardization, analysis, and reporting to successfully transitioned multicenter longitudinal cohort studies to the cloud. This enabled us to provide SAS/SQL tools for preprocessing large datasets and ultimately creating numerous custom objects in JReview for the purpose of medical monitoring.

Rescue Services

The previous programming team, without a background in statistics, depended on code from an earlier study to perform the current analysis. Two weeks before the deadline, the lead programmer quit, leaving behind a defective codebase for the internal reviewers. A rapid source-to-target mapping using study documents and updated data definition tables uncovered significant discrepancies. The analysis datasets were overhauled, and tables and figures were processed with validated macros just in time for stat review!