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Aggregate Reports are a critical part of the ongoing monitoring of drug safety during the life cycle of a product. During clinical development, a Development Safety Update Report (DSUR) is required. During the post-marketing phase, and depending on the markets involved, other types of report may be required for the renewal of marketing authorisation including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), and Addendum to Clinical Overviews (ACOs).
These aggregate reports form a comprehensive, systematic, and periodic way of collection and synthesis of safety information. They have the same basic aims but are used at different points within the drug development and marketing life cycle.
A DSUR presents a comprehensive and critical analysis of the balance between the benefit and the risk to patients from the use of a medicinal product under development, considering the data from Clinical Trials.
A PSUR (or PBRER or PADER), provides a periodic evaluation of the benefit-risk profile of an authorised medicinal product and is submitted to regulatory authorities at predefined frequencies.
An ACO provides additional, updated information about a product's benefit-risk profile, including safety and efficacy, to support regulatory renewal process.
Aggregate reports follow strict international guidelines to ensure they provide a thorough and accurate reflection of a drug's safety and are typically undertaken by experienced Medical Writers. They are a key requirement in regulatory compliance, ensuring the ongoing assessment of a product’s benefit-risk profile from trials through to established marketed pharmaceuticals.
The preparation of an annual plan, considering all local and regional requirements.
Oversight of the Aggregate Report schedule to identify what needs preparation and when.
The organisation of a Kick-off meeting to plan and agree the timelines for data sources collection, drafting, review and approval. This must take into account the submission date as per all local and regional requirements.
The request and collection of all relevant data from various sources, including relevant internal departments and/or from the client/Marketing Authorisation Holder (MAH).
The creation of a draft Aggregate Report that follows regulatory guidelines, all local and regional requirements, and the agreed annual plan timetable.
A quality review of the draft Report.
A Medical review of the draft report conducted by a qualified Safety Physician.
A Final review by the Head of our Pharmacovigilance Department.
A Final approval by MAH (and QPPV, if applicable)
Submission of the Aggregate Report as per all local and regional requirements, and deadlines.
Planning - this must be fully aligned with the latest local requirements through our world leading iViReg Regulatory Intelligence platform, and includes the annual schedule, the time plan for creating each report, and the distribution of the Request for Information (RFI) to all the relevant contributors for their input into the individual chapters within the structure of the report.
Assistance with harmonising the Development International Birthday (DIBD) in DSURs, and the International Birthday (IBD) in PSURs.
Data collection – The coordination and creation of all required data tables, and if used, their automatic export with our iViSight analytics platform for Argus Safety Database users.
Report preparation, QC, medical review and approval and subsequent submission.
We also handle all legal requirements, and together with our team of Medical Writers and Safety Physicians, we ensure that every report is created and reviewed by qualified and experienced experts that fully understand the requirements of all parties, adapting each report to your specific needs.