Quality Assurance

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

Overview of Expertise

  • Global compliance management
  • Gap analysis investigation for companies or internal departments
  • Developmental oversight of Quality Management Systems (QMS)
  • Internal and external auditing and compliance strategy planning and guidance
  • Vendor and site auditing on behalf of sponsors (and internally as part of our own QMS)
  • Development of required policies / SOP preparation /review / approval
  • Development and implementation of change management programs
  • Development and implementation of change and/or training programs of all quality-related aspects and metrics
  • Oversight of the development and delivery of all quality-related training (including regulatory updates and current GCP training)
  • Clinical quality oversight on behalf of a company
  • Rapid assistance in managing quality issues that arise during the course of a study