Aggregate Reports

Our approach to data is both quantitative and qualitative. We do not stop with compiling your safety data, we help make sense of it and help maintain the risk-benefit of your treatments.

For efficient and effective review of line listings, frequency tabulations and trend reports to establish the benefit-risk evaluation of your marketed drugs in Canada. To ensure compliance to regulatory requirements, we perform collective analysis of drug safety cases of your drug through periodic reporting and aggregate reports. Our work will help you take the necessary steps including regulatory documents update and notifying the Health authorities in a timely manner.

Medical Writing
Services

Aggregate Reports

From compiling your drug safety information to preparing your PSUR for Health Canada, we help you stay compliant with all the requirements.

We provide medical writing support for aggregate reports development and compilation such as Annual Summary Reports (ASRs), PBRERs PSURs

Signal Detection and Benefit- Risk management

Establishing a causal relationship between reported adverse events and specific medicinal products/conditions allows you to take timely action and reduce that risk. We handle this process to ensure all signals undergo Validation, Prioritization, and Assessment in a manner that ensures continued patient safety.

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