agComposer™

periodic & aggregate report generation

Periodic reports—PSURs, ASRS, and Risk Management Plans (RMPs)—not only help to ensure regulatory requirements are met in a timely manner, they also provide the opportunity to document a product's safety profile as it changes over time.

Meet your full periodic and aggregate reporting obligations

agComposer (formerly SafetyComposer™) is Aris Global's comprehensive periodic and aggregate reporting system that schedules, creates and tracks a full range of submission-ready, ICH-approved periodic reports, including PSURs, bridging reports and other annual reports such as the ASR.

Integration improves collaboration

agComposer works seamlessly with any safety system, including ARISg™, to simplify and automate the process of periodic report preparation. agComposer is fully integrated with Aris Global's agSignals™, an advanced signal detection and data mining system, aiding in benefit/risk analysis. Users can perform detailed analyses of safety data within the specified reporting period and support the assessments provided.

Once the clock is ticking, agComposer automatically sets deadlines and reminders to ensure that your reporting obligations are met on time. As a periodic or aggregate report is due, it can only be generated in cooperation with other departments. agComposer fully integrates the required departments and processes-clinical trial, regulatory and medical information-to ensure deadlines are met and reports meet the various regulatory agency requirements.

Report templates automate authoring, editing and content approval

agComposer offers users a variety of pre-defined templates when initiating a report. Different templates, comprised of chapters and sub-chapters, can be created based on the type of periodic report submitted.