Simplify Aggregate Reporting For Accurate Compilation and Submission of Cumulative Safety Information
Aggregate reporting is a critical process that involves the review of cumulative safety information from a wide range of sources, on a periodic basis. MAHs and sponsors need to timely prepare and submit findings about the product’s risk and benefit profile over time to regulatory agencies worldwide. Importantly, Aggregate reports are required during both pre-marketing and post-marketing stages of a product. These aggregate reports are required during both pre-marketing and post-marketing stages of a product. Each of these reports identifies and highlights a specific aspect of risk or benefit. The aggregate reports for respective stages are listed below.
Pre-marketing Aggregate Reports
- Clinical Study Reports (CSRs)
- IND annual reports in the USA
- Development Safety Update Report (DSUR)
- Annual Safety Reports (ASRs) in Europe
Post-marketing Aggregate Reports
- Periodic Safety Update Report (PSUR)
- Periodic Benefit-Risk Evaluation Report (PBRER)
- Periodic Adverse Drug Experience Report (PADER)
- NDA and ANDA Annual Reports
Common Aggregate Reporting Challenges
Introducing Compier Aggregate Reporting
Compier Aggregate Reporting is one of the industry's best digital platform to manage the entire lifecycle of timely preparing and sumbitting different types of pre-market and post-market aggregate reports across your global safety programs. It facilitates rapid digital authoring, collaborative review, electronic approval and speedy publishing of aggregate reports in the mandated regulatory approved format.
Solution Features & Benefits
We offer the Compier Aggregate Reporting solution using the Software as a Service (SaaS) model with a standard Service Level Agreement (SLA). Additionally, Techsol shall also provide professional services to complete the successful implementation, configuration, validation, and global rollout of the Compier Aggregate Reporting system along with the required system integrations.
Compier Aggregate Reports is a GxP regulatory compliant software system that fulfills FDA’s 21 CFR Part 11 and EU Annex 11 requirements. Techsol will provide the complete IQ/OQ validation documentation during the time of system implementation.
Our subject matter experts will deliver a hands-on Compier PV Aggregate Reports application training to your application champions by using ‘Train-the-trainer’ approach. Trainings will be delivered primarily through web conference using standard presentations.
The Compier PV Aggregate solution architecture is designed to support various types of system integrations to eliminate manual effort and facilitate stakeholder collaboration across different PV business functions for increasing quality, compliance, and productivity.
The system supports a wide range of external system integrations using RESTFUL APIs and file-based data exchange transactions. Our approach towards integrations with third party solutions is based on industry standards, web services, APIs, and open architecture-based solutions.