With tight turnaround and five years after study completion, George Clinical brings new staff up to inspection standards and trial passes inspection with no significant findings.

SITUATION

George Clinical completed a Phase III, randomized, double-blind, double-dummy, parallel group, local registration trial on cancer pain in 2013 and 2014. The trial covered 28 sites and 230 patients. In 2019, the national drug administration of China (NMPA) scheduled a regulatory authority inspection of clinical sites as part of a new drug application process implemented in 2015 when Chinese regulators began to mandate several processes such as self-assessment and on-site inspection to be required for NDA approval. This was done to improve the quality of data generated in clinical trials, and there are penalties in place for non-compliance with the mandate. The long delay in inspection resulted from the need to finish any other clinical trials within the same program and submit a complete dossier to the NMPA followed by the actual evaluation process, which can take a significant amount of time.

CHALLENGES

Clearly, the length of time from study completion to the inspection created many challenges including the fact that some of the site monitors from the original trial were no longer with George Clinical. Guidelines and regulations had also changed in this time, and both Principal Investigators from the trial had retired from the sites.

We were also given the extremely short notice of only one week prior to inspection for preparations including supply procurement and getting a new George Clinical team familiar with the study materials. This was also an insufficient time period in which to perform 100% source data review and verification.

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