There is no standard answer to the question whether the sponsor establishes a team of monitors to do clinical research or outsources clinical research to CRO. Sponsors often outsource a large number of projects to CROs. After a period of time, they find that there is a problem with the quality of control, and then take them back to do it themselves. After doing it for a while, I felt uneasy and started outsourcing a lot. This cycle goes back and forth, vacillating.
In fact, various methods have their own advantages and disadvantages, and the “good” of one method may be the “bad” of another. Understanding the pros and cons of various situations is conducive to good management of quality and schedule.
There are two main situations for the sponsor to outsource projects to CRO companies: one is outsourcing to internationally renowned brand CRO companies, and the other is outsourcing to small and medium-sized CRO companies with better cost performance. The author analyzes the pros and cons of these two situations.
The biggest advantage of the sponsor outsourcing the project to an international brand CRO company is that the quality is more assured. The brand CRO company has a complete quality management system and rich project experience, and the probability of major quality problems is relatively small. At the same time, if the project is outsourced to an international brand CRO company, the clinical research leader of the sponsor will feel that his own responsibility is less. The project is handed over to the international brand CRO company, and perhaps the drug administration department can feel that the product’s efficacy and safety are relatively strong. These are the advantages of outsourcing projects to international brand CROs.
The first disadvantage of outsourcing projects to international brand CRO companies is price. This price is not only the price when the contract is signed, but also the price of subsequent changes to the service content. In fact, after signing the contract with the CRO and starting the project, the sponsor began to be in a relatively disadvantaged state.
In addition, there are some other risks. For example, all CRO companies are now facing the problem of a shortage of experienced first-line inspectors. For brand CROs, there may also be cases where frontline inspectors are not experienced enough. In addition, the main service targets and long-term partners of brand CRO are often large global multinational companies. Even if Chinese companies can spend huge sums of money to use brand CRO companies, they may still sit in the last row with brand CRO companies. These items may not be the best inspectors. The sponsor’s sense of pride when signing the contract echoes the sad face behind it. As mentioned earlier, if the sponsor is not a major customer of the brand CRO, the CRO will be slower, and the sponsor will have little choice.
Another point is that the work objectives of international brand CROs are different from those of the sponsor. The goal of the sponsor is that clinical studies can reflect the efficacy and safety of the drugs studied. The goal of the brand CRO is that the execution of clinical research can be fully in line with the procedures. The high degree of specialization of the CRO company has led to a high degree of proceduralization of the work of the inspectors, which has turned the inspectors into brainless screws working on the assembly line. But after all, the clinical research industry is different from Foxconn, which produces parts, and the work of an inspector is not entirely mechanical.
The sponsor outsources the project to small and medium-sized CRO companies. The price is often lower than that of international brand companies, and will be more cautious in subsequent additional costs. After all, they have to consider the following business. In addition, small and medium-sized CRO companies may treat the sponsor as a VIP customer, and they need to be more dedicated in service, and they do not need to count every action as money. Many key personnel of small and medium-sized CRO companies have also worked in international brand companies and have management experience, so the quality of the project is not necessarily worse than the brand CRO.
However, the sponsor outsourcing the project to small and medium CRO companies will have the following problems:
The first is personnel issues. Big brand CRO companies, like pumps, constantly remove slightly more experienced inspectors from small and medium CRO companies. Big brand CRO companies get projects with high prices and high salaries to attract experienced inspectors. Inspectors joining the brand CRO will not only increase their salary, but also their experience in the brand CRO will be recognized by the market and their value will also increase. This kind of talent competition has made small and medium-sized CRO companies unable to fight back, and they have reached a state of being slaughtered.
Secondly, the sponsor will package the project to the CRO and interview the CRO personnel. However, some CROs who participate in the interview are not the same person who actually conducts on-site inspections. This is especially true for some small third-party inspection companies. The general manager participates in the interview, and the workers below are novices. The experience of the inspectors is not as good as that of the inspectors. Clinical research is an industry based on integrity, and integrity is the most important professionalism in the clinical research industry. Without integrity, other abilities are zero.
In order to retain experienced inspectors, small and medium-sized CRO companies often work hard on the company culture to establish a good working atmosphere. This may also lead to a decrease in the binding force of the company’s management on the frontline inspectors. If the front-line inspectors do not work well, the company has no good solutions.
At the same time, if the sponsor outsources the project to small and medium-sized CRO companies, the person in charge of the project bears greater pressure. If it is outsourced to a CRO that is too small, there is a suspicion of using power for personal gain. If you really use power for personal gain, then the CRO will not do it well.
In short, the sponsor outsources the project to a CRO company, whether it is outsourced to a large international brand CRO company or to a small and medium-sized CRO company, it will have its own problems. However, there are also problems when the sponsor does it by itself.
Clinical research is a systematic project, and various systems need to be established to ensure that the project is carried out with high efficiency and high quality. When the sponsor’s project was launched, it was rushed, and clinical research needs to be initiated immediately. At that time, the system and personnel of the clinical research department might not be complete, so they could only be contracted to the CRO company.
At the same time, because of different goals, it is difficult for the sponsor’s own clinical research team to adopt the assessment standards of CRO companies. CRO companies require employees to complete the required work within the specified time. Give money when you do the job, regardless of the result. Inspectors work hard, but they are also worry-free. The work goal of the sponsor is that the drug can be marketed. Therefore, the sponsor cannot manage the inspector like a CRO. In order to mobilize the initiative of the inspectors, the sponsor will not quantify the management of its own inspection team as detailed as a CRO. As mentioned earlier, the quantitative results of the CRO company cause the CRO’s inspectors not to spend time doing anything other than the prescribed actions. But many things in clinical research are not fully covered by a set of prescribed procedures, and there are often many changes. Change and quantification are contradictory. The sponsor will not ignore any changes, because changes often create risks. Therefore, the sponsor generally does not quantify the work of the inspector. However, this kind of non-quantitative work mode, although the work intensity is not as great as CRO, but it is not at all worrying, it is always worried. At the same time, there will be inertia if there is no quantification. Gradually the department becomes bloated and people are overwhelmed. Then they think about outsourcing.
In short, outsourcing and doing it yourself have their own difficulties. How to maximize strengths and avoid weaknesses is a question that needs to be discussed.
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