Quality with efficiency is the primary objective of the National Medical Products Administration (NMPA) (formerly named CFDA) in the past few years started with the 722 storm in China in 2015. Many new regulatory requirements and guidelines relating to clinical research were implemented thereafter, resulted in upsurge demand for efficient model for clinical research management and oversight in academic institutions or hospitals.
In response to this hot area, Chinese Pharmaceutical Association invited representatives of HKU-CTC to share its successful experience in developing an authentic Site Management Organization (SMO) in managing clinical research in HKU/QMH at its ‘2018 Annual Meeting of Chinese Pharmaceutical Association Research Committee for Drug Clinical Evaluation cum Clinical Research Forum’ on 10-11 November 2018 in Guangzhou. More than 400 participants from various backgrounds, including government officials, study site personnel and industry partners attended this event and the success of HKU-CTC’s SMO model has drawn much attention of different clinical trials stakeholders after the forum.