The Food and Drug Administration (FDA) and European Medicines Agency (EMA) are the world’s most authoritative drug regulatory authorities. Their clinical trial inspection standards are stringent, covering key aspects such as protection of subjects’ rights, consistency between source data and case report forms, and full-process traceability of drug management. As a trusted clinical research partner for sponsors, Medkey Clinical consistently commits to providing comprehensive support through meticulous management and expertise empowerment in the face of complex international inspections.
In December of last year and April of this year, we assisted one U.S. global pharmaceutical company in successfully passing FDA inspection for its Phase III renal cancer study conducted at a site in Beijing, and another U.S. global pharmaceutical company in successfully passing FDA inspection for its Phase III breast cancer study conducted at a site in Shanghai, with zero significant deficiency.
Meanwhile, in March of this year, we assisted a Chinese domestic biotechnology company in successfully passing EMA inspection with zero significant deficiency for its innovative drug in ovarian cancer at two sites in Zhengzhou and Shenyang, fully demonstrating the Medkey Clinical team’s high standards and quality in SMO services.
Notably, we have passed five FDA/EMA inspections with zero deficiency in the past six months, with our cumulative zero-deficiency passes now exceeding ten. This achievement is the result of the project team’s sustained efforts. In the face of such highly challenging tumor projects, the team has maintained strict control over SMO service quality throughout several years of treatment follow-up. From subject follow-up management and raw data verification to document archiving and compliance training, we strive for precision and accuracy in every aspect. It is this sustained professional investment that enables us to face international inspectors with confidence.
The value of Medkey Clinical lies not only in execution, but also in empowerment. We help clients transform complex clinical trial processes into controllable, credible, and verifiable high-quality SMO service through standardized SOP systems, forward-looking risk prediction mechanisms, and efficient communication bridges between sponsors and research centers. The successful completion of this EMA verification is not only a recognition of the professional ability of the Medkey Clinical team, but also a demonstration of our ability to empower clients and achieve excellence.
In the future, Medkey Clinical will continue to strengthen our professional capabilities, enabling more innovative drugs to meet international regulatory standards and benefit global patients at the earliest opportunity.
