Aggregate Reporting

Overview

Aggregate safety reports provide a periodic, cumulative evaluation of safety information collected from multiple sources over a defined reporting interval. They help organizations assess whether new safety information changes the known safety profile or benefit-risk balance of a medicinal product.

Mediature GxP Solutions Pvt. Ltd. (MGS) supports Marketing Authorization Holders, pharmaceutical companies, CROs, and other life-sciences organizations with preparation, review, coordination, and quality control of aggregate safety reports.

Our approach integrates ICSR data, literature findings, signal information, exposure data, regulatory actions, product information, risk-management activities, and medical evaluation to support complete, consistent, and traceable aggregate reporting.

Our Aggregate Reporting Services

PSUR Support

Support for preparation and review of Periodic Safety Update Reports in accordance with applicable reporting requirements and reporting intervals.

PBRER Support

Preparation and review support for Periodic Benefit-Risk Evaluation Reports, including cumulative safety evaluation and benefit-risk discussion.

DSUR Support

Support for Development Safety Update Reports for applicable investigational products and clinical-development programs.

Data Collection & Coordination

Collection and organization of required safety, regulatory, clinical, exposure, literature, and product information from relevant functions and stakeholders.

ICSR Data Review

Review and summarization of cumulative and interval safety cases for inclusion in aggregate reports.

Literature Review

Assessment and summarization of relevant scientific and medical literature identified during the reporting period.

Signal Information Review

Integration of ongoing, validated, closed, or newly identified signals into the appropriate aggregate safety sections.

Exposure Data Support

Compilation and review of available patient exposure, sales, prescription, clinical-trial, or other relevant exposure information.

Benefit-Risk Evaluation Support

Structured assessment of whether cumulative safety information has a meaningful impact on the established benefit-risk profile.

Regulatory Action Review

Compilation of important regulatory or company safety actions taken during the reporting interval.

Medical & Quality Review

Support for scientific, medical, editorial, consistency, and quality review before report finalization.

Aggregate Reports We Can Support

Depending on product status and regulatory requirements, MGS can support:

• PSUR
• PBRER
• DSUR
• Periodic safety summaries
• Product-specific safety reviews
• Ad hoc cumulative safety analyses
• Supporting safety sections for regulatory submissions

Key Data Sources

Aggregate reports may incorporate information from:

• Spontaneous ICSRs
• Solicited reports
• Literature cases
• Clinical studies
• Post-marketing studies
• Regulatory authority information
• Partner safety data
• Signal-management activities
• Risk-management activities
• Product complaints with safety information
• Medical information
• Exposure data
• Previous aggregate reports
• Reference safety information

Key Aggregate Reporting Considerations

MGS may support evaluation of:

• Reporting interval
• Data lock point
• Product exposure
• Cumulative case data
• Serious and non-serious events
• Fatal cases
• Important identified risks
• Important potential risks
• Missing information
• New safety findings
• Literature findings
• Signal status
• Regulatory actions
• Label changes
• Risk-minimization activities
• Benefit-risk implications
• Previous commitments
• Data consistency
• Submission readiness

Our Approach

• Plan

Confirm report type, reporting period, data lock point, responsibilities, timelines, required inputs, and submission expectations.

• Collect

Gather relevant safety, exposure, literature, regulatory, signal, and product information.

• Reconcile & Review

Review source data for completeness, consistency, duplicates, discrepancies, and alignment across contributing functions.

• Analyze

Evaluate cumulative and interval safety information, trends, signals, important risks, and potential benefit-risk implications.

• Draft & Review

Prepare report sections and support medical, scientific, regulatory, and quality review.

• Finalize

Address review comments, perform consistency and quality checks, finalize the report, and support submission readiness.

Typical Deliverables

Depending on scope, MGS can provide:

• Aggregate-report planning tracker
• Data request templates
• Safety data summaries
• Literature summaries
• Signal summaries
• Exposure-data compilation
• PSUR draft
• PBRER draft
• DSUR draft
• Benefit-risk evaluation support
• Medical-review support
• Quality-control checklist
• Comment-resolution tracker
• Final report support
• Submission-readiness package

Why Choose MGS

Integrated PV Data Review

MGS brings together case data, literature, signals, risk information, exposure, and regulatory developments within a coordinated reporting process.

Medical & Scientific Focus

Aggregate reporting is approached as a cumulative safety evaluation, not only as a document-compilation activity.

Quality & Consistency

Our review process focuses on consistency between tables, narratives, safety conclusions, signals, and other report sections.

Timeline Management

Structured planning and tracking help support timely completion of complex periodic reports.

Flexible Support Model

MGS can support complete report preparation or selected activities such as data compilation, literature review, medical review, quality control, or section drafting.

Who We Support

MGS can provide Aggregate Reporting support for:

• Marketing Authorization Holders
• Pharmaceutical companies
• Biopharmaceutical organizations
• CROs
• Generic-drug companies
• Clinical-development organizations
• Product-license partners
• Organizations managing multiple periodic safety reports