Outsourcing CRO or doing it yourself? Analysis of the advantages and disadvantages of three options in clinical research

On February 23rd, the medical website sponsored the team to set up a team of inspectors for clinical research, or outsourced clinical research to CROs. There is no standard answer to this question. The sponsors often first outsource the project to the CRO in large numbers. After a period of time, they found that the quality of the control was problematic and they took it back and did it themselves. After doing it for a while, I felt uneasy and started to outsource a lot. This cycle reciprocates and swings.

In fact, each approach has its own advantages and disadvantages. The "excellent" of one approach may be the "bad" of another approach. Understanding the pros and cons of various situations is conducive to good management of quality and progress.

There are two main situations in which the sponsors outsource the project to the CRO company: one is outsourcing to the internationally renowned brand CRO company, 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.

Handed over to the brand CRO ?

Poor price!

The biggest advantage for the sponsor to outsource the project to the 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, outsourcing the project to the international brand CRO company, the sponsor of the clinical research will feel that their responsibility is smaller. The project is handed over to the international brand CRO company, and it may be possible to administer a sense of efficacy and safety of the administrative department. These are the advantages of outsourcing projects to international brand CROs.

The disadvantage of outsourcing projects to international brands CRO is first of all the price. This price is not only the price at the time of signing the contract, but also the price of the subsequent changes to the service content. In fact, after signing a contract with the CRO and starting the project, the sponsors began to be in a relatively inferior state.

There are other risks besides this. For example, all CRO companies now face the problem of shortage of experienced first-line auditors. For brand CROs, there may also be cases where the first-line monitors are not experienced enough. In addition, the main service targets and long-term partners of the brand CRO are often large multinational companies around the world. Chinese companies can use the brand CRO company even if they spend a lot of money, but in the brand CRO company, Chinese companies may still sit in the last row, assigned to These projects may not be the best monitors. The pride of the sponsor when signing the contract echoes with the frowning face behind. As mentioned above, if the sponsor is not a big customer of the brand CRO, the CRO is slower, and the sponsor has almost no way.

Another point is that the international brand CRO's work target is not the same as the sponsor. The sponsor's goal is that clinical research can demonstrate the efficacy and safety of the drug being studied. The goal of the brand CRO is that the implementation of clinical research is fully compliant with the procedure. The highly specialized nature of CRO has led to a high degree of procedural work for the inspectors, turning the inspectors into brainless screws that work on the assembly line. However, the clinical research industry is not the same as Foxconn that produces parts. The work of the monitor is not a complete mechanical work.

Small and medium-sized CROs are cost-effective.

But be alert!

The sponsors outsourced the project to small and medium-sized CRO companies, which are often lower in price than international brand companies, and will be more cautious in the subsequent additional costs. After all, the latter business should be considered. In addition, small and medium-sized CRO companies may treat the sponsor as a VIP customer, and do more with the service, and do not have to count the money for each action. The main responsible personnel of many 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 will outsource the project to small and medium-sized CRO companies with the following problems:

The first is the personnel issue. The brand-name CRO company, like a water pump, constantly withdraws a little experienced auditor from small and medium-sized CRO companies. The brand big CRO company gets the project at a high price and attracts experienced auditors with high wages. The auditors joined the brand CRO, not only the wages rose, but also their own experience in the brand big CRO will be recognized by the market, and the value is also rising. This kind of talent competition, the small and medium-sized CRO company has no way to fight back, has already reached the state of being slaughtered.

Secondly, the sponsor will package the project to the CRO and will need to interview the CRO staff. However, some CROs who participate in the interview are not the same person as the actual auditor who performs the on-site inspection. Some small third-party auditing companies are even more so. The general manager is involved in the interview. The following is a newcomer. The experience of the inspectors is still not up to the monitor. Clinical research is an industry based on integrity, and integrity is the most important professional in the clinical research industry. Without the integrity, other abilities are zero.

In order to retain experienced auditors, small and medium-sized CRO companies often work hard in the company culture to establish a good working atmosphere. This may also result in a decline in the company's management's ability to bind the first-line auditors. If the frontline monitors don't work well, the company has no good idea.

At the same time, the sponsors outsourced the project to small and medium-sized CRO companies. The pressure of the project leader is relatively large. If the CRO is outsourced to a small CRO, there is also the suspicion of using power for personal gain. If you really want to gain power, then the CRO will not do it well.

Does the sponsor do it by himself?

There are also problems!

In short, the sponsor will outsource the project to CRO, whether it is outsourcing to a large CRO company of international brands, or to small and medium-sized CRO companies, they will have their own problems. However, the sponsor has problems with it.

Clinical research is a systematic project, and it is necessary to establish and perfect various systems to ensure that the project is carried out with high efficiency and high quality. The sponsor's project was in a hurry and needed clinical research to start immediately. At that time, the systems and personnel of the clinical research department may not be available and can only be packaged for CRO.

At the same time, because the target is different, it is difficult for the sponsor's own clinical research team to adopt the assessment criteria of CRO. CRO requires employees to complete the required work at the specified time. When you do your job, you will give money, regardless of the outcome. The auditors work hard, but they also worry. The target of the sponsor's work is that the drug can be listed. Therefore, the sponsor cannot manage the monitor like the CRO. In order to mobilize the initiative of the auditor, the sponsor's management of the audit team will not be carefully quantified like the CRO. As mentioned earlier, this quantitative result of CRO companies has caused CRO's monitors to take no time to do anything other than the prescribed actions. But many things in clinical research are not completely 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, as changes often create risks. Therefore, the sponsor generally does not quantify the work of the auditor. However, this kind of work mode without quantitative, although the work intensity is not as big as the CRO, but it is not worrying at all, and it has to be worried. At the same time, no quantification will produce inertia, and gradually the department becomes bloated, people are overstaffed, and then they think about outsourcing.

In short, outsourcing and doing it yourself have their own difficulties. How to develop strengths and avoid weaknesses is a question that needs to be discussed.