Aggregate Safety Reports

Our post-approval product safety and pharmacovigilance (PSPV) group assists pharmaceutical and biotech companies in preparing periodic reports. We provide country-specific reports, such as the U.S. new drug application (NDA) periodic report and the harmonized International Conference on Harmonisation (ICH) E2C-format periodic safety update report (PSUR). Periodic report compilation includes periodic and annual reports.

Quality Focus, Deadline Driven

Our PSPV professionals work closely with your designated safety contacts to complete draft periodic reports for your review well in advance of regulatory submission dates. We have a keen understanding of the need to coordinate receipt of diverse information originating from myriad departments within your company.

Client Focused

During project implementation, we conduct extensive training on your medicinal products and their clinical applications, client-specific procedures, templates and conventions, and proprietary safety databases. Our PSPV group provides:

• Specialized knowledge and understanding of periodic reports
• Benchmarking experience in working with a diverse client mix
• An ability to mobilize a validated safety platform on a client’s behalf
• The option for shared workflow with a client in periodic report preparation
• Generation of periodic reports in multiple formats and time frames

Services Provided

PPD provides compilation of:

• Worldwide market authorization status reports
• Updates on actions taken for safety reasons
• Individual case histories for inclusion
• Line listings
• Summary tabulations by system organ class (SOC)
• Published safety literature review

Other aggregate safety report services include:

• Quantification of patient exposure
• Medical assessment and review
• Epidemiologic assessment and review
• Trending analysis and signal detection
• Risk assessment and management
• Quality assurance review
• Regulatory submissions