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Patient Safety Is Our Top Priority
PATIENT & DRUG SAFETY
Development of safe drugs, biologics, vaccines and medical devices is critical to their pre- and post-approval therapeutic success. Two decades of experience working directly with the US FDA and Health Canada has enhanced our patient and drug safety expertise in the following areas:
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Clinical Trial Safety Management
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Medical Monitoring (24/7 Physician Coverage)
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Safety Physician Oversight
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Case Narratives
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Individual Case Safety Reports
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Expedited and Periodic Reports
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MedDRA and WHO - Drug Coding
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Risk Evaluation and Mitigation Strategies (REMS) / Risk Management Plans (RMPs)
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Clinical Safety Sections of NDAs, ANDAs, NDS and ANDS
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Drug Prescribing Information and Product Monographs
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SOP Development