From the point of view of clinical operation, the drug scale-up estimation + global project management + global regulatory compliance was discussed; and drug transport consideration in epidemic situation - remote blinding, D2P, cross-site drug taking and other special case considerations can be brought in

The journey to the sea of Chinese pharmaceutical companies is walking forward, being full of thistles and thorns. In this topic, we discussed the key points of data management in the whole lifecycle of MRCT, the problems and challenges of data management in MRCT projects, and effective solutions with industry colleagues.

In the global situation and impact of COVID-19 pandemic, it becomes so important in this period for the following aspects, how to conduct the tests under study, especially the global clinical projects successfully, what dimension of risks are to be considered, and how to develop measures in line with project management.

From the current situation of medical device clinical trial industry in China, we discussed the series of impacts of the new regulations on registrants, clinical agencies, contract research organizations (CROs) and the future industry globalization, taking into account the new changes faced by medical device clinical trials under the new regulation environment