Quality Assurance

We 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:

  • Managing global compliance activities
  • Conducting internal “gap analysis” activities for companies
  • Developmental oversight of Quality Management Systems (QMS)
  • Devising internal/external audit and compliance strategies
  • Conducting vendor and site audits on behalf of Sponsors and internally as part of our own QMS
  • Developing required policies/SOP preparation/review/approval
  • Creation/implementation of change/training programs of all quality related aspects and metrics
  • Oversee the development/delivery of all quality related training including regulatory updates and current GCP training
  • Provide clinical quality oversight on behalf of a company
  • Provide assistance in managing quality issues that arise during a course of a study