Secondly, the internationalization of qualification certification standards. As an important part of the global pharmaceutical industry value chain, CRO is bound to be in line with the global standards system. After the establishment of SFDA, China vigorously promoted the establishment of GMP, GCP, GLP and other quality standard systems, and gradually moved closer to the quality standard systems of western developed countries. But it is undeniable that compared with the strict quality system of western developed countries, especially the United States, China still has a long way to go. For the real outsourcing business of new drug research and development, how to meet the standards of western countries (such as the GLP standard of FDA) will also be a necessary condition for the future development of CRO local enterprises.
The third is the further promotion of advanced R&D operation technology and service management process in CRO industry. Mainly manifested in CRO enterprises to strengthen the professional technology of drug discovery and establish a research and development model that conforms to the development of new technologies represented by biotechnology. In order to meet the requirements of timeliness, EDC, a network tool, was established to strengthen contact with the trial site and speed up the clinical trial process.
Fourth, technological innovation and expansion have become the focus of enterprise competition. In addition to clinical trials, CRO's business is expanding to a wider range of fields. In some developed countries, CRO has extended its services to drug research and development, preclinical research, pharmacoeconomics, pharmacogenomics, drug safety evaluation, phase I-IV clinical trials, trial design, selection of researchers and experimental units, monitoring, auditing, data management and analysis, informatics, clinical documents, policy and regulation consultation, product registration, production and packaging, and promotion. How to make CRO local enterprises have the technical expertise and global, high-quality technology development and clinical trial management capabilities required by pharmaceutical companies to meet the new drug market demand of these large pharmaceutical companies will also be the future development goal.
Finally, the adjustment of CRO industrial structure was accelerated. With China's entry into WTO and the acceleration of economic globalization, large multinational CRO enterprises seize the development prospect of China's pharmaceutical market and the advantages of R&D cost, and set up CRO enterprises with foreign investment background in China in the form of sole proprietorship, joint venture and cooperation. With the continuous development of CRO industry in the future, the competition will inevitably become international. How to effectively cooperate with multinational enterprises, digest and absorb advanced technology, form their own technological advantages and adapt to the new competitive environment will be an important topic before us.