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
- Inefficiencies in compiling data for drafting pre-marketing and post-marketing aggregate reports
- Don't have a provision to manage their aggregate reporting schedule for different regulatory agencies
- Lengthy redundant and error-prone process to create aggregate reports without pre-defined templates
- Delays in completing report review and sign-off with manual sharing of documents and wet-ink signatures
- Poor visibility on aggregate report submission outcomes with disconnected communication and no historical tracking
- Lack of awareness on reporting delays and other issues that could result as findings during audits and inspections
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
Pre-defined Aggregate Report Templates
Leverage pre-defined Aggregate Report templates for various types of reports such as PADER, PSUR, PBRER, DSUR, CTPR for speedy report creation. Additionally, the system is flexible and allows your team to create new templates wherever required.
Rapid Digital Authoring of Aggregate Reports
Eliminate using traditional standalone software and leverage Compier to digitally author any type of aggregate report directly on your web browser. The system offers all authoring components to create tables, insert charts, images and manage the entire report format.
Collaborative Reports Review and Approval
Initiate real-time collaborative aggregate report review and approval with multiple team members for fast and smooth digital sign-off with electronic signatures.
Aggregate Reporting Schedule Management
Create and manage global aggregate reporting schedules / timetables with calendar trackers with a comprehensive oversight of reporting timelines.
Streamline Aggregate Reports Development
Define and configure workflows from scheduling, and authoring to submission by setup user access and permission controls as to who can view, edit, review, approve aggregate reports. Stay informed on workflow tasks assignments, workflow tasks, and related activity updates
Automate Table Calculations in Reports
Compier automatically calculates the safety summary tables in aggregate reports such as PSUR, PADER, PBRER, etc. by importing and validating safety database line listings. This saves 50% of the users' time spent in manual error-prone authoring of reports.
Correspondence and Collaboration
Leverage the built-in centralized Compier mail inbox which streamlines all stakeholder communication and information exchange between MAH and partners.
Process Alerts & Notifications
Proactively address all operational issues and stay informed on the progress of all partner activities through configurable system alerts and notifications.
Aggregate Reports Generation & Distribution
With Compier, PV Teams can generate accurate aggregate reports in the mandated regulatory format. The final PDF Reports can be scheduled and distributed to global teams.
Perform Aggregate Reporting Oversight
Leverage Compier's built-in reports and dashboards to track adherence to the aggregate reporting schedule and perform comprehensive oversight of safety compliance across programs.
Solution FAQs
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.
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