Masuu Global provides end-to-end support in aggregate reporting, ensuring that PADER and PSUR reports are accurately prepared, thoroughly analyzed, quality-controlled, and compliant with regulatory requirements for successful submission and approval.
Periodic Adverse Drug Experience Report (PADER) and PSUR:- PADER/PSUR Preparation:
We prepare comprehensive Periodic Adverse Drug Experience Reports (PADER) and Periodic Safety Update Reports (PSUR) to meet regulatory requirements. - Data Integration:
Integration of data from various sources to provide a complete overview of drug safety over a specified period.
- Data Extraction:
We generate detailed line listings from the pharmacovigilance database, summarizing individual case safety reports (ICSRs). - Compliance:
Ensuring that the line listings comply with regulatory standards and guidelines.
- Initial Drafting:
We create initial drafts of aggregate reports, incorporating all relevant data and analyses. - Client Collaboration:
Collaborating with clients to refine and review the draft reports to ensure accuracy and completeness.
- Expert Review:
Our medical experts conduct in-depth analyses of the data, providing insights into trends, patterns, and potential safety signals. - Scientific Interpretation:
Interpretation of clinical data to support the overall safety evaluation of the drug.
- Quality Control:
Rigorous quality control checks are performed on the draft reports to ensure data accuracy, completeness, and compliance. - Error Correction:
Identifying and correcting any discrepancies or errors in the report before finalization.
- Client Approval:
We work closely with clients to obtain final approval on the aggregate reports, ensuring all concerns and feedback are addressed. - Regulatory Submission:
Assisting clients in submitting the final approved reports to regulatory authorities, ensuring timely and compliant submissions.