Wizard is adept at creating aggregate reports per regulatory agency guideline for aggregate report writing of EU RMP/RiskMAPs/REMS/PIPs, SUSAR, PSUR, PADER, ASR, DSUR, SBR and other aggregate reports. At Wizard has experienced clinical/medical writers with specific therapeutic areas with relevant medical degrees who are experts in medical assessment, risk assessment and interpretation with clinical/medical judgment.
Wizard has a unique modular approach to aggregate reporting activities that emphasizes an organized effort in the writing of PSURs, ASRs and other aggregate reports. At Wizard, experienced and trained personnel write all sections of the reports including medical assessments, risk assessment plans, executive summary, and the business and sales section.
A dedicated medical team provides guidance, as well as single case reporting, to ensure that medical consistency is maintained across all reporting forms. Our team’s objective is to optimize the periodic report preparation process in order to enable the surveillance and signal detection that allows for the delivery of greater patient safety.
Aggregate Reporting Services Include :
- Tracking of reporting periods and submission dates
- Generation of tables and listings from safety database
- Analyze line listings and prepare relevant tables
- Analyze previous aggregate reports for the product
- Compose case summaries and analysis
- Draft report for client review and approval
- Medical review of each report