Aggregate Safety Report Generation and Reporting
High-Quality Postmarketing Report Writing
Within aggregate safety reports, safety data from relevant sources are periodically reviewed and assessed for patients’ safety and well-being.
At Gemini Group, our team works meticulously to ensure compliance with applicable regulations for aggregate safety reports. We have industry leading expertise in pharmacovigilance and aggregate safety report writing. We have real-world experience from the pharmaceutical industry, regulatory authorities, and academic settings. We will support you with both advices in aggregate safety data analyses and in overall benefit-risk assessments.
Aggregate Safety Report Services and Know-how
Our full Aggregate Safety Report services include strategic planning, time management, data requests, writing, quality control, strategic advice, technical advice, communication, and evaluation. We have comprehensive subject matter expertise in analyzing and evaluating safety data. We work methodically and accurately to generate required periodic reports such as the Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), and Risk Management Plans (RMPs).
