Track and log adverse events from your clinical studies in real-time using our specially designed Adverse Event Tracking Software, providing trial safety departments with an easy-to-use system to handle all safety events from all of your current studies.
Our Adverse Event Tracking Software offers a well-organized system that enables safety personnel in clinical trials to efficiently document, categorize, investigate, and report adverse events associated with all ongoing studies. All phases of the adverse event tracking process, from capturing the adverse event and coding it in MedDRA to causality assessments, expedited submission to authorities, and aggregate reporting, are performed within our single software solution.
Give every safety team a single system for managing adverse events that keeps trials compliant, reporting deadlines met, and trial participants protected at every stage.
See Software DocumentationStructured capture forms, automated MedDRA coding, and regulatory timeline tracking built into every adverse event workflow. Every event is documented correctly from the moment it is reported.
There is support for the capture of adverse events data in a structured manner through electronic case report forms that can be configured to automatically code using MedDRA and WHO Drug Dictionary terminology, determine the severity and seriousness of events, and evaluate causality according to ICH E2A standards. An alert system warns of imminent deadlines for expedited reporting requirements.
Explore AE Capture FeaturesFDA, EMA, PMDA, and Health Canada reporting requirements built into every workflow. Jurisdiction-specific compliance that keeps every safety report accurate and on time.
The program has jurisdiction-specific expedited reporting guidelines, serious adverse event guidelines, and electronic submission guidelines to suit all of the major international regulatory authorities. Compliance verification checks each adverse event report against the relevant regulatory guidelines prior to its being submitted, ensuring lower query frequency.
View Regulatory Compliance DetailsIndividual events connected to aggregate trends, automatically and in real time. Safety signal detection that keeps pharmacovigilance teams ahead of emerging risks before they escalate.
The use of inherent aggregated safety analysis features ensures that pharmacovigilance and safety groups have the ability to recognize emerging signals, detect trends in adverse event frequency, and perform benefit/risk analyses on the entire adverse event data set, enabling the safety decisions necessary to ensure the safety of all current trial subjects.
Learn About Signal Detection Tools