Quality

  • Clinical Quality Systems

    • Clinical SOPs development

    • Create and implement Corrective and Preventive Action (CAPA) process

  • Clinical Quality Assurance and Compliance

    • Study site oversight tools

    • Clinical trial trends

    • Corrective and Preventive Action (CAPA) development, implementation and follow-up for clinical internally and externally

  • Training

    • Develop training tools and documents for clinical trials

    • Establish clinical study training processes for internal personnel, external vendors and trial sites

    • Develop training materials for pre and post-market studies  

    • Provide training on GCP, Compliance, FDA inspections, CAPA, PMA-panel 

  • Due Diligence

    • Establish quality controls and processes for different clinical functions

    • Preparation for FDA BIMO and EU regulatory audits

    • Conduct clinical due diligence for mergers/acquisitions 

  • Vendor Audits

    • Conduct audits

    • Gap analysis

    • Corrective and Preventive Action (CAPA) tools and management

  • Clinical Sites Audits

    • Regulatory documents review

    • IRB approval and ICF review

    • AE/SAE/UADE reporting

    • Product accountability

    • Protocol deviations

    • Source documentation review

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