Clinical Audit in Pharmaceutical Development

Clinical quality assurance audits, performed to ensure that scientific and ethical standards are met in the conduct of clinical trials, are conducted using proprietary computerized audit tools, customized to each project, so that GCP audit findings can be efficiently and consistently collected, analysed and reported. This focused systems-oriented approach to quality assurance is designed to assess and validate study conduct and documentation to ensure regulatory compliance and conformance to protocol, SOP and contractual requirements. Methodology should evaluate the activities and documentation underlying study data integrity and Good Clinical Practice (GCP) ethical and regulatory requirements.

  • Clinical investigator site audits
  • CRO and SMO audits

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