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Upgrade CRO

In June 2008, located in Taizhou, China Medical City, held a "new drugs created with the CRO Forum." Period, the organizers played CRO industry to develop slogans.
"At present, the level of China's CRO industry is roughly equivalent to Japan 10 years ago. Japan's CRO industry has been relatively standardized, but in China have not formed a certain 'rules of the game'." Guangzhou Ji-Bo Wang, general manager of new drug clinical research center recently for Ting Chun told reporters.

Two main risks for

July 5 is the site of drug clinical trials, a professional network of clinical trials on the 5th anniversary celebration, this is only a parts CRA (clinical supervision of the Clerk) gatherings, but attracted Quintiles, Guangzhou Bo Ji, universal and other former CRO to participate. As the CRO the past two years to develop the hot, medicine, people want to take this opportunity to do more to share.
Shanghai New Medicine Development Co., Ltd. Deputy General Manager Liu Ye told reporters that the entire drug development process, clinical trials is a very profitable part of it. However, due to cost reasons, pharmaceutical companies will outsource an increasing proportion of R & D, thus for the CRO industry development has brought tremendous business opportunities. "In addition to screening of compounds of the structural modification of lead compounds, preclinical pharmacology and toxicology testing and other services, currently many domestic CRO companies are engaged in clinical trials business."
CRO companies in China is not difficult to set up, the cost is relatively low, but really want to do is not easy. In particular, in the relevant laws, regulations and industry self-regulation needed to improve the situation, CRO companies face many problems, of which, capital-chain operations and policy change is the CRO companies face two major risks.
Particularly in the financial chain operation, the attending the celebration of a certain industry sources, domestic small number of CRO's in the receipt of orders, and pre-paid funds to begin the project after the operation. "In this process, if the project could not proceed as planned, accounts receivable financing delayed, it may cause the company's overall capital chain CRO dysfunctional. If the CRO's pre-advance implementation of the project funds, once the reasons for commissioning party can not make implementation of the project continue, then, CRO company's liquidity position may also be problems. "The former official said that once the project must be continuously input, after completion of the project is the final lump-sum amount due CRO company profits.
Wang Ting Chun is added, the project implementation did not go often because the funds entrusted to its own side chain of a problem, in this case, CRO's very difficult to recover payment.
Policy risks, since the concept of national CRO to some extent been over-generalization, CRO company not only to conduct clinical research, clinical trials, is also involved in program design, new drug approval and so on. On the one hand, the majority of domestic companies are required commission approval CRO companies to participate in work; On the other hand, CRO companies often will "ensure the adoption and acceptance" and other slogans as part of its promotion of business.
The actual situation is that as new drugs for approval will take time, during which, CRO, once a pilot program designed to catch up with policy changes may result in approval is not approved. In this way, the program must be re-adjusted, and "who pay the cost of initial investment," CRO company has become a very troublesome problem.
U.S. BrightechInternational Chairman Thomas Xie's remarks might be able to provide some reference for the country. He said that in the United States, CRO company only implementation of the project who is not responsible for program design, does not involve approval. Under normal circumstances, they signed an agreement with the customer, the customer will be prepaid at least 10% of the start-up capital, in the recruitment of the subjects after the first payment of a sum, after the payment is carried out under the contract. If the project can not be the final implementation, customers are required by the contract-related payment.

To be standardized

This reporter learned that, "clinical trials of drug quality control standards" (GCP) has been enacted five years, but in recent years, some new problems CRO industry, need to be further standardized.
For example, the domestic part of the CRO companies to compete for orders and use of ultra-low pricing, and some offer no guarantee that even the basic clinical trial costs. At the same time, some pharmaceutical companies nor the formation of irregular habit of rigorous scientific research in pursuit of short-term interests as the center, to make GCP a mere formality.
Quintiles Medical Development (Shanghai) Co., Ltd. Zhang Haixia, said vice president of clinical operations, subject to the industry price war, at present is still the main business of Quintiles Transnational pharmaceutical companies for the start, and less acceptance of the commission of domestic enterprises.
According to Liu Ye revealed that at present some domestic companies registered as "pharmaceutical consulting firm," but in fact, been carried out CRO services. "In Beijing, for example, to carry out a number of CRO business enterprises, but really formal clinical research throughout the enterprise are very few."
When the development of the industry to a certain stage, reorganization of resources to achieve CRO upgrade is necessary, since the ultimate result of shuffling, you can still achieve a large integrated companies and small and highly specialized CRO's CRO companies coexist. "Like to buy shirts, and some people to buy imported brands, it was also willing to spend in the low-end products, enterprises have their own customer base and targeting, rather than the state of cohabitation." One guest says.