Based on extensive quality assurance experience across all areas of clinical trial conduct and our expertise in SOP development, we provide professional consulting services to support the establishment of our clients’ Quality Management Systems.

We provide practical guidelines that incorporate both domestic and international regulatory requirements, including Good Clinical Practice (GCP), to ensure that our clients’ clinical trial processes remain fully compliant with all applicable regulations. This ensures the reliability and accuracy of clinical trial data, while supporting our clients in responding and confidently to regulatory authority inspections and approval reviews.

Leveraging extensive quality assurance experience across diverse therapeutic areas, domestic and international projects, and a wide range of implementing institutions, we provide customized clinical trial inspection services. Based on a deep understanding of the latest guidelines and requirements from regulatory authorities worldwide, we apply these standards in real clinical trial environments to support the successful conduct of clinical trials by our clients.

At the pre-initiation stage, we review the adequacy of the protocol and essential documents. During the trial, we assess the quality of monitoring activities and compliance with procedures. After trial completion, we verify the accuracy and reliability of the captured data. Through such end-to-end inspections, we help ensure that our clients’ clinical trials meet international quality standards, proactively minimize risks in advance of regulatory inspections, and contribute to securing reliable clinical data.

Through a risk-based quality management (RBQM) system based on the ICH E6(R2) guideline, we proactively identify and manage critical risks throughout the clinical trial lifecycle. Risk assessment procedures focused on data integrity and participant safety are implemented early in trial design, prioritizing key data and activities for efficient, targeted quality management. Through continuous risk monitoring, we detect and address potential quality issues early in the trial, ensuring consistent quality throughout the study.