STUDYTRAK™ REPORTER

StudyTrak™ Reporter enables the centralization of serious adverse event (SAE) reporting across multiple clinical trials, Contract Research Organizations, and investigators. It provides visibility into safety data throughout a clinical trial and maximizes the efficiency of sponsor and site personnel.

When an investigator reports an SAE or event of interest to the Sentrx Safety Response Center, StudyTrak™ Reporter provides our Safety Monitors immediate access to investigator, patient and trial details. It populates the known data fields of the SAE report form from the clinical trial management system, then guides the Safety Monitor to request all necessary information during the first and subsequent interactions with the site. Edit checks and coding to common dictionaries improve the quality and consistency of the data collected, reducing follow-up questions and the associated time to resolve each inquiry.

StudyTrak™ Reporter is implemented within the Sentrx Safety Response Center in conjunction with the SafetyTrak® Clinical Trial Safety Solution. It can also be deployed at investigator and sponsor sites worldwide to enable online reporting of SAEs and real-time access to data at any point in a clinical trial.