Amgen operates in a regulated environment and the Clinical Quality Assurance (CQA) Department evaluates the quality and compliance of all aspects of Amgen’s clinical development processes against regulations and guidelines.

We highlight risks and facilitate the sharing of best practices. Our CQA personnel visit investigator sites, Contract Research Organisations (CROs), vendors and Amgen affiliates. We also assess Amgen’s internal processes and facilitate Good Clinical Practice (GCP) regulatory inspections. We share our knowledge of regulations, guidelines, Standard Operating Procedures (SOPs) and current inspection issues to help improve processes across a variety of teams and work streams within International Research and Development.