Clinical Data Automation (eSource)
Our CPU in Antwerp is equipped with an eSource system, ClinSpark®, allowing for collection of study data directly into electronic format. eSoure technology has simplified the Phase I Unit workflow from recruitment, through study conduct, all the way to database lock, and allows access to all study data in one place.
Data Monitoring: The eSource allows for data visualization, verification and query management at the source level. The real-time access allows for continued data monitoring by Medical Monitor, CRA and Data Manager, ensuring faster query resolution. Reporting: Build-in reporting tool with standard reports and the possibility to extract real-time data files for monitoring activities. Data Management: In collaboration with SGS Data Management, direct data transfer into the Clinical database is possible. The eSource design allows for SDTM like annotations transferring the collected data into an SDTM inspired data export file. Available in excel, CSV and XPT format.
Subject recruitment: The eSource includes the full volunteer database, allowing for faster volunteer selection (including configurable inclusion and exclusion rules) and scheduling of appointments. Study Design and Direct Data Capture: Use of (sponsor) specific libraries allow for rapid protocol setup in the eSource system. The design allows for rapid adaptations during the trial.
Real-time, bar-code driven study data collection: results in a over 90% reduction of paper source/processes. The DDC ensures direct capturing of data from devices (Vital Signs, ECG, etc.). The process is barcode driven (subject, dose, collection, instruments), and includes edit checks and alerts, thus resulting in increased data quality. Automated Sample Management: barcode driven sample management ensures tightened control of the sample processes.
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