Meeting Periodic Safety Reporting Obligations

Periodic safety reports – like the Periodic Safety Update Report (PSUR), Annual Safety Reports (ASR), Development Safety Update Report (DSUR), Periodic Adverse Drug Experiences Reports (PADER), 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. agComposer_Image

However, the generation of high-quality periodic reports is time consuming and requires careful planning and coordination by various departments of a life sciences company. A lot of the time is spent on the compilation and formatting of the report itself, taking away time for the analysis of the safety profile of the product.

agComposer is Aris Global’s comprehensive periodic reporting system that simplifies the process of scheduling, writing and tracking submission-ready periodic reports.

agComposer automates the periodic report creation process and expedites the

preparation of all periodic reports including post marketing (PSUR, PADER), pre-marketing reports (DSUR) and other reports like summary bridging and addendum reports.

As with all Aris Global products, agComposer is available on premise or on demand (SaaS).

Automated Content Creation Using Repeatable Report Templates

agComposer automatically calculates report deadlines and sends reminders to ensure that an organization’s reporting obligations are met on time. For authoring, agComposer facilitates collaboration between different departments whose inputs may be required for completing periodic reports. A simple, role-based workflow allows users who are responsible for authoring, reviewing or approving the content of a particular section to ensure deadlines are met and monitors completion of their activities in the stipulated timelines.

agComposer offers users a variety of ready-to-use templates including PSUR, DSUR, etc. New templates can be created based on the format defined by any regulatory authority and can be easily modified to support the preparation of new periodic reports.

Key features include:

Monitoring of both internal and submission schedules

Automated content creation based on a frozen data set

Standardized, repeatable report templates

Simple workflow capability for distribution of reporting tasks based on roles and responsibilities

Report preparation and progress tracking

Submission tracking

Flexibility to support a new or updated report by creating a template

Delivering Business Value

agComposer fully integrates the required departments and processes to ensure deadlines are met and that reports meet the requirements of the respective regulatory agencies with high quality.

The following are just a few of the key benefits that agComposer delivers:

Reduces report compilation time allowing experts to concentrate on data analysis for better risk management

Ensures compliance with all international reporting obligations for periodic reports including ICH E2C (PSUR), ICH E2F(DSUR), Risk Management Plan (RMP), PADER, Addendum report, etc.

Streamlines the periodic report preparation process across the organization

Allows companies to respond quickly to modified or new regulations

Tracks deadlines and ensures that no regulatory obligations are missed

Helps maintain inspection readiness by providing periodic report submission