Whatever your reporting needs, we can handle it.
Our experts can handle all your Aggregate Safety Reporting obligations throughout the life cycle 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) or Addendum to the Clinical Overviews (ACOs).
From compiling your DSUR information to preparing your PSUR for the EMA (European Medicines Agency) and/or PADER for the FDA, we have the deep knowledge and expertise you need to stay fully compliant with all the requirements.
Period benefit-risk evaluation report (PBRER/EU PSUR).
A PBRER, also known as a EU PSUR (Periodic Safety Update Report) in Europe, is a periodic post-marketing regulatory document. It provides 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/EU PSUR planning, preparation, and submission.
Periodic Adverse Drug Experience Report (PADER/PAER).
In the US, medicinal products approved by the USFDA 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 These documents, that have been largely superseded by the submission of PBRERs, must be submitted quarterly for the first 3 years and annually thereafter.
Our expert medical writing team can support you in the preparation of a PADER, or with the preparation of a global PBRER.
Development Safety Update Report (DSUR) preparation and submission.
The DSUR includes 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.
Line listings/periodic reports.
We prepare all Serious Adverse Event (SAE) line listings, biannual line listings, frequency tabulations, and trend reports, as applicable. We can also propose additional solutions and customizable reports to fit your requirements.