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Aggregate Report Development and Submission

Accomplished Authoring and Quality Reviews for Drug and Drug-Device Regulatory Compliance

ClinChoice’s team of safety and regulatory experts adopt a collaborative approach to create high-quality periodic and ad-hoc safety reports.

We have extensive experience in:

  • Periodic Benefit/Risk Evaluation Reports (PBRERs)
  • Periodic Safety Update Reports (PSURs)
  • Post-Marketing Safety Report
  • Integrated Summaries of Safety (US)
  • Canadian Aggregate Reports (CARs)
  • Summary Bridging Reports (SBRs)
  • Periodic Adverse Drug Experience Reports (PADERs)
  • PRAC/Health Authority Responses
  • Developmental Safety Update Reports (DSURs)
  • Benefit/Risk Profile Reports
  • Literature Search, Analyses, and Ad-Hoc Benefit/Risk Assessments
  • Data Analysis and Risk Communications
  • Subject Matter Expertise for Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS)
  • Risk Minimization Plans (RMP)

Over the years of our service, we have excelled in managing the aggregate report authoring and submission process. We partner with our clients in:

  • Maintenance of the Aggregate Reporting Calendar
  • Generation of Listings from the Pharmacovigilance Database
  • Technical and Medical Review of the Reports
  • Response to Health Authority Queries