Noahpharm's quality management system focuses on control of study specific risks, and ensures data integrity and subject protection and safety. In accordance with the quality management principles, GCP guidelines and pharmaceutical regulatory requirements, we follow the company policy and project control requirements and establish the complete operation department’s standard operation procedures (SOP) and quality management systems. Our quality assurance system ensures the protocol compliance and identifies quality risks.

  •  Establish and optimize clinical quality management system, including SOP quality management manual that complies with regulations
  •  Study site audit, including varied phases of clinical trials for drugs and medical devices
  •  Supplier qualification audits and routine audits, such as PK laboratory, central laboratory, phase I ward and computer system (e.g., CTMS, eTMF)
  •  Risk management-based process audits, such as audits on TMF, informed consent process, protocol writing and safety information submission
  •  Self-inspection, inspection preparation, inspection onsite support, and proactive and effective responses to ensure optimal inspection results
  •  Risk assessment, major GCP issue investigation, trend analysis, guidance on fundamental reason analysis, and formulation of corrective and preventive actions and validity check