Aggregate Safety Report Generation and Reporting

Best in Class Post-marketing Report Writing

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Within aggregate safety reports, safety data from pertinent sources are regularly reviewed and assessed for patients’ safety and well-being.

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At Gemini Group, our consultants works meticulously to ensure compliance with applicable regulations for aggregate safety reports. We have industry leading experience and a tremendous amount of knowledge in aggregate safety report writing. Our consultants have hands-on experience from the pharmaceutical industry, regulatory authorities, and academic settings. We will help you with advice in aggregate safety data analyses and in overall benefit-risk assessments.

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Aggregate Safety Report Services and Know-how

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Our full Aggregate Safety Report services include strategic planning, time management efficiency procedures, data requests, writing, quality control, tactical advice, robust communication, and dynamic assessment. We have wide-ranging experience in analyzing and evaluating safety data. We are subject matter experts when it comes to generating 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).