What is Aggregate Reporting?
Over the lifecycle of a product, cumulative or ‘aggregated’ safety information is gathered into reports on a periodic basis over time and submitted to National Competent Authorities. Aggregated reports are based on ICH guidelines and enable an understanding of the Benefit-Risk profile of a product, and how that changes over time as more Real World Data becomes available at different development and post-marketing stages.
Throughout development, and for Marketing Authorization Holders, aggregate reports demonstrate the ongoing monitoring and assessment of the Benefit-Risk profile of products, and can identify any new risks over time.
Whatever your reporting needs, we can handle it.
Our experts can handle all your aggregate reporting obligations throughout the lifecycle of your products, from development to market, through the preparation, medical review, and submission of a wide range of aggregate reports, including:
- Development Safety Update Report (DSUR),
- Periodic Benefit-Risk Evaluation Reports (PBRERs),
- Periodic Adverse Drug Experience Reports (PADERs),
- Addendum to the Clinical Overviews (ACOs).
From compiling your DSUR information to preparing your PSUR for the EMA and/or PADER for the FDA, we have the deep knowledge and expertise you need to stay fully compliant with all the requirements.
Line listings/periodic reports.
We can prepare all SAE line listings, biannual SUSAR line listings, frequency tabulations, and trend reports, as applicable. We can also propose additional solutions and customizable reports to fit your requirements.
Development Safety Update Report (DSUR) preparation and submission.
DSURs provide a comprehensive overview of your investigational medicinal product’s benefit-risk evaluation and compliance with applicable regulations. We provide a full DSUR writing and submission service to guide you through or manage the process.
Period Benefit-Risk Evaluation Report (PBRER) and Periodic Safety Update Report (PSUR).
PBRERs provide a global overview for a particular active substance through a comprehensive cumulative and interval analysis of safety and efficacy data for all strengths, indications, and/or formulations.
Our experts can support you with all stages of your PBRER/PSUR planning, preparation, submission, and follow-up.
Periodic Adverse Drug Experience Report (PADER).
In the US, medicinal products approved by the US FDA need to submit regular PADERs summarizing the post marketing experience of the product. These documents, that have been largely superseded by the submission of PBRERs, must be submitted quarterly for the first three years and annually thereafter.
Our expert medical writing team can support you in the scheduling, alignment, and preparation of your aggregate safety reports.