Patient Well-Being Is Our Core Value
Protecting the safety of patients is critical to the success of any drug product. With over two decades of pre- and post-approval experience working directly with the US FDA and Health Canada, our drug safety expertise includes:
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Clinical Trial Safety Monitoring
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Medical Monitoring including availability of therapeutic area specialists(24/7 Coverage Provided by In-House Physicians)
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Safety Physicians
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Case Narrative Writing
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Individual Case Safety Reports (ICSRs)
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Expedited and Periodic Reports
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MedDRA and WHO - Drug Coding
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SOP Development
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Risk Evaluation and Mitigation Strategies (REMS) / Risk Management Plans (RMPs)
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Medical Information
We achieve a compliance rate of >99% for on-time safety reporting in a constantly evolving regulatory environment.