Data Collection Efficiency for a Novel Anti-Infective Therapy
A CREATIVE DATABASE DESIGN APPROACH STREAMLINES DATA CAPTURE FROM PHASE II-III
The complex situation begins with a 200 patient Phase II trial that needs a database built to accommodate an interim analysis while still enrolling and treating patients, a recommendation from the Regulatory Agency. Due to the patient disease-state, the study duration for each patient was less than one month, yet the amount of data collected was much higher than a typical study. For example, most patients had more than 100 concomitant medications and more than 60 medical history reports to collect.
Learn how we designed the database to allow the sponsor to lock patients for the interim analysis and keep enrolling and continue to capture data for all ongoing patients.
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