Aggregate Reports

Overview

CONTINUUM has best-of-class capabilities for the analysis of grouped/aggregate data for a drug over a prolonged period of time (months or years) and the subsequent incorporation of such data into prescribed reports on behalf of our clients. These reports include:
  • PBRERs/PSURs
  • PADERs
  • PSUR Addendum Reports
  • PSUR LL Reports
  • ACOs
  • IPSRs
  • SUSAR Reports (six-monthly)
  • DSURs
  • Drug Safety Reports/Ad-hoc reports
  • PQC reports/HHEs

For all the reports above, we help determine strategy, review and analyze data/literature/signals, provide guidance, and review and implement comments.

Additional services, such as generation of listings for Aggregate Reports, Clinical Expert Statements and Independent Quality Reviews, are also offered.

Medical Writing

CONTINUUM'S team of experienced scientists and physicians offer services for preparing
  • RMPs and RMP Updates
  • Safety Narratives for Clinical Study Reports & Protocols
  • Clinical Summaries/Product Feasibility Reports for Medical Devices
  • Guided Questionnaires
  • Company Core Safety Information

Our Services

Dedicated Customer Teams & Agile Services

Our strong team of experts ensures the professionalism, expertize, timeliness & cost efficiency required to ensure that your plans are carried out as needed.