Site Audit Data Analysis 2020-2023

From April 2020 to May 2023, we performed 113 investigator site audits.

73% were phase III trials, followed by phase I trials with 12%, and phase II and IV were less involved

Investigator sites are mainly distributed in Shanghai and Beijing

Regarding the types of sponsors involved, proportion of domestic biopharmaceutical companies is 49%, followed by multinational companies of 41%

The indications involved a variety of therapeutic fields, among which oncology dominates the largest proportion, coming in at 52%

In terms of the finding grades, most were Minor findings sharing 79.54%, followed by Major 20.32% and Critical 0.15% respectively

The highest occurrence of Major findings was source data recording with AE/SAE reporting next and monitoring activities related findings accounted for the third