Research On Interior MIS Of China's CRO

CROs emerged in China in 1997, when several of the world's leading CROs established a presence in Beijing. Contract research has experienced explosive growth since then, and today China is home to more than 300 CROs of all sizes. This growth has been fueled by demographic changes and economic trends, as well as recognition of the opportunities associated with a market whose potential has been estimated at up to $1 billion. China's CRO faces both challenges and opportunities. The low cost of drug development (The cost of drug development in China is 20% of that of in the U. S. and many other countries) and the large domestic market potential, plus government support promise to continue its growth trend. But lack of clinical trial management experiences and low quality in clinical trial, Lack of experience in regulatory and other specialized areas and irreality of clinical trial data plus most CROs in miniature, these disadvantages obstruct China CRO's progress. And these disadvantages also let foreign medicine industries down; they don't like to cooperate with China's CRO in clinical trial research. As the key point of clinical trial is high quality and reality data, it is hard to let them trust the data and results made by China's CRO. So it has become the urgent issue that China's CRO must solve, and only do that can increase CRO's core-competitiveness, ensure CRO develop rapidly and healthily.This paper set up an internet-based interior management information system (IMIS) based on the advanced experience from foreign CROs. It focuses on the study of theory foundation, thinking system and main function of IMIS. By analyzing validity of IMIS, internet-based IMIS can assure China's CRO obey SOP during the clinical trial management, provide high quality and reality data, compare staff's efficiency, manage project costs, and support business department offer reasonable. It will accelerate the development of China's CRO and enhance CRO's core-competitiveness.