Aggregate Reports
ICBio, provide reliable and efficient pharmacovigilance aggregate reporting services. We understand the substantial responsibility and effort involved in preparing pre-approval and post-marketing aggregate reports.
The ICBio medical writing team can support you in the scheduling, alignment, and preparation/ submission of all types of aggregate reports.
Stand-alone or End-to-end Services
* Period Benefit-Risk Evaluation Report (PBRER) and Periodic Safety Update Report (PSUR)
* Development Safety Update Report (DSUR)
* Periodic Adverse Drug Experience Report (PADER)
* Risk Management Plans (RMP)/REMS
* Periodic Adverse Drug Experience Report (PADER) * ACO
* Health Authority (HA) Requests
* Canada Annual Summary reports
*PSUR Addendum reports, PSUR Line Listings Reports * SUSAR reports (six monthly)
* Clinical Overviews / Ad-hoc reports, special projects, review of lit & listings,
* Other services (Clinical Expert Statements, Generation of Listings for Aggregate Reports, call for information, Data set Generation.
* Clinical trial Reconciliation, Exposure Calculations, Publishing, Archiving, Translation support.
* Independent Quality Review & Quality Assurance.
For all the reports above, we help determine strategy, review, and analyze data/literature/signals, provide guidance, review, and implement comments.
Aggregate Experience
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