GlobVigilance

  • Phone : +91 9350029763
  • Email : Support@GlobVigilance.in
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Aggregate Reporting

Home > Aggregate Reporting

1) OUR SOLUTION HELPS ALL TYPES OF AGGREGATE REPORTS IN:

  • determine strategy,
  • provide guidance,
  • review and analyse data/literature/signals, and
  • review and implement comments

2) COMPLIANCE WITH REGULATORY REQUIREMENTS & ENSURES APPROPRIATE FORMATTING OF:

  • periodic reports, safety summaries, and risk assessment documents

3) TYPE OF AGGREGATE REPORTS:

  • 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