Accurate and timely submission of adverse event safety reports is critical to compliant clinical study execution. Finding a cost effective, enterprise-ready safety management system has been difficult until now.

ClinApps™ AETS v1.7 application for the management of adverse events that occur during investigational studies, will allow you to simplify the data collection process, automate the production and distribution of dynamic reports and ensure security and accuracy utilizing digital signatures.

By providing immediate control over your adverse event reporting process and the flexibility to make quick and economical updates using a simple drag-and-drop interface, this application is essential for any trial.

Easy to use interface based on Microsoft technology
Supports regulatory compliance without affecting existing configuration
Enhances the adverse event processing & streamlines regulatory reporting
Adverse Event Forms can be received via fax, the web or mail
Provides customizable workflow, per study, for handling the different adverse event severities defining tasks, steps and approval responsibilities as they move through the notification and review lifecycle
Create deadlines and email notifications to manage the timing of movement through the various stages of an Adverse Events lifecycle
Will track & manage safety case information according to your unique internal processes
Capable of attaching supporting documentation & files (i.e. lab reports, etc.) to safety case files
Easily set up new studies and assign the characteristic of how adverse events for that study are to be handled
Ensures security and accuracy of digital signatures including a time-stamp of when document was last modified since signature was applied
Easy backup and restore processes for document libraries to prevent data loss