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