Quality Assurance

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We establish quality structures and streamlined approaches to reduce risk and reinforce operational innovation in the changing landscape of clinical quality and compliance.

We ensure that quality structures and streamlined approaches are implemented within the clinical trial setting to reduce risk and reinforce operational innovation in clinical quality and compliance.

Quality Assurance Team:

  • Provide clinical quality oversight of clinical trials and programs
  • Manage all aspects of global quality compliance activities:
    • Provide assistance in managing quality issues, including analysis and documentation
    • Conduct “gap analysis” activities
    • Provide oversight of Quality Management Systems (QMS)
    • Devise internal/external audit and compliance strategies
    • Conduct vendor and site audits
    • Develop policies and SOPs, including managing review and approval process
    • Create and implement quality-based training programs, including providing global regulatory updates and reviewing current GCP requirements

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