Aggregate Reporting (PADER/PSUR)

At Masuu Global, we provide comprehensive end-to-end support for aggregate reporting, specializing in the preparation of Periodic Adverse Drug Experience Reports (PADER) and Periodic Safety Update Reports (PSUR). Our services ensure that these reports are accurately prepared, thoroughly analyzed, quality-controlled, and compliant with global regulatory requirements for successful submission and approval.

We understand the critical role of PADER and PSUR in pharmacovigilance and regulatory compliance. By leveraging our expertise, your organization can meet regulatory requirements with precision, ensuring ongoing drug.

Our Aggregate Reporting Process:
  1. PADER/PSUR Preparation
We begin by preparing comprehensive PADER and PSUR reports that align with global regulatory guidelines, including FDA, EMA, and ICH E2E requirements. Our team ensures that:
  • Complete and Accurate Reporting: Every relevant piece of safety data is included in the reports to provide an accurate overview of the drug’s safety profile.
  • Timely and Compliant Submissions: We ensure that reports are prepared in accordance with regulatory deadlines and compliance guidelines, enabling successful and on-time submissions.
  1. Data Integration
To provide a thorough safety evaluation, we integrate data from multiple sources, including:
  • Individual Case Safety Reports (ICSRs): Extracting and analyzing data from adverse event reports.
  • Clinical Trials: Incorporating data from ongoing clinical trials and studies.
  • Literature & Post-Marketing Data: Including findings from published medical literature and real-world evidence.
  1. Generation of Line Listing from the Database
  • Data Extraction: Our team generates detailed line listings from the pharmacovigilance database. These line listings summarize individual case safety reports (ICSRs), allowing a clear snapshot of the adverse events.
  • Compliance: We ensure the line listings adhere to regulatory standards and guidelines, such as those from the FDA, EMA, and ICH.
  1. Draft Report Creation
  • Initial Drafting: We create an initial draft of the PADER or PSUR, incorporating all integrated data and analyses, with a focus on highlighting critical safety findings, trends, and any emerging safety signals.
  • Client Collaboration: We collaborate with our clients to refine and review the draft reports, ensuring that all data and analyses are correctly interpreted and presented. This collaborative approach ensures that the reports reflect both the data and the client’s expectations.
  1. Medical Analysis and Expert Review
  • Expert Review: Our team of medical experts conducts an in-depth analysis of the data, identifying trends, patterns, and potential safety signals that may require further investigation or action.
  • Scientific Interpretation: Using our scientific expertise, we interpret clinical data and provide insights to support the overall benefit-risk evaluation of the drug. This helps ensure that the report is clinically sound and accurate in its assessment of drug safety.
  1. Quality Control (QC) of the Report
  • Rigorous QC Checks: We conduct comprehensive quality control (QC) on the draft reports to verify that all data is accurate, complete, and compliant with regulatory standards.
  • Error Correction: Any discrepancies, errors, or gaps identified during the QC process are promptly corrected to ensure the highest quality of reporting.
  • Final Report Validation: This step ensures that the report is finalized with complete confidence in its accuracy and regulatory compliance.
  1. Final Client Approval
Once the draft has undergone medical review and rigorous quality control, we work closely with the client to obtain final approval. This step ensures:
  • Feedback Integration: Any final client feedback or concerns are addressed to guarantee that the report meets the client’s needs and expectations.
  • Approval for Submission: Upon approval, the report is ready for submission to regulatory authorities.
  1. Regulatory Submission
Masuu assists clients with the final step: submitting the approved PADER or PSUR reports to the relevant regulatory authorities. Our services ensure:
  • Timely Submission: Reports are submitted in alignment with the regulatory deadlines, avoiding any delays in compliance.
  • Successful Approval: With our rigorous process, we aim to ensure that every report meets regulatory standards and is accepted by health authorities.
Book a Demo