Quality
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Clinical Quality Systems
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Clinical SOPs development
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Create and implement Corrective and Preventive Action (CAPA) process
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Clinical Quality Assurance and Compliance
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Study site oversight tools
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Clinical trial trends
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Corrective and Preventive Action (CAPA) development, implementation and follow-up for clinical internally and externally
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Develop training tools and documents for clinical trials
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Establish clinical study training processes for internal personnel, external vendors and trial sites
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Develop training materials for pre and post-market studies
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Provide training on GCP, Compliance, FDA inspections, CAPA, PMA-panel
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Due Diligence
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Establish quality controls and processes for different clinical functions
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Preparation for FDA BIMO and EU regulatory audits
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Conduct clinical due diligence for mergers/acquisitions
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Conduct audits
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Gap analysis
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Corrective and Preventive Action (CAPA) tools and management
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Clinical Sites Audits
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Regulatory documents review
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IRB approval and ICF review
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AE/SAE/UADE reporting
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Product accountability
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Protocol deviations
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Source documentation review
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