Great question- I would have to say that if I were a sponsor, I would not want to transfer the responsibilities of: selecting monitors & investigators and overall managing/checking investigators. The reason why I selected these was because most of the other work that a sponsor is responsible for can usually be learned very quickly, such as record keeping, filing IDE’s/safety reports, maintaining a quality system, manufacturing/ storing/ packaging/ labeling product, and creating the financial disclosure. However, selecting monitors/investigators and managing them is a task that requires more interpersonal skills, and ultimately needs to be someone that you can trust to do the job right. Outsourcing this task to a CRO could result in the sponsor and investigator or monitor not getting along or not meeting expectations.

Your last two words meeting expectations raised another very important question. What if the CROs do not meet the expectations or deliver the expected result?

And I agree with your choice of responsibilities that will be better if handled by the sponsor himself. Monitors and investigators are the key components in the clinical trial. If you do not know the monitors/investigators of the task you transferred over, then you as a sponsor won't be satisfied with the results. If you personally know who is working on your task and their ability to think outside the box. Then you will be more likely to get the results you expected.

Again, what do you guys think happens if a CRO is unable to deliver the expected results? Has this ever happened from your experience or to your knowledge?

Hi All,

This is a very good question. I actually work with a company that helps Pharmaceutical companies to connect with CROs and I found it quite surprising how much they are willing to outsource through these companies. Many of them they have established relationships with for many years so they trust them with huge and extremely important studies.

With regards to your other question about what occurs if a CRO is unable to deliver. This is usually decided upfront with a long contract process. It typically outlines exactly what will occur if the study is not completed, how much the CRO will be paid, and what will be done to compensate for this study. They are often very careful to ensure these terms are setup to protect both them and the client.

-Andrew Nashed

If a CRO is not able to deliver the expected results I am sure there is language within the contract specifying this possible outcome and steps to take to get a proper return on their money and resources. Usually, strong and well supported clinical trials are executed for over 5 years or more. This ensures that the proper data and research is collected as well as evidence that properly claims that the device is not harmful and performs as intended. For some instances, this allows the company to observe possible side effects of the device that may be observed during the trials and correct the issue or label the product with this side effect.

Using a CRO can usually over an objective assessment to a company when it comes to its drug/device and the resultant outcomes. CROs are usually well versed in conducting and managing clinical trials set forth by a company. This is usually a better round to recieve sound and unbiased feedback and regulated control of a clinical trial.

I believe that the only responsibility that the sponsor cannot outsource to any CRO is the overall responsibility of the clinical study. I think that any adverse events, injuries and risks will be the responsibility of the clinical study sponsor not the CRO.

As for the advantages of transferring clinical study to CROs, it mainly occurs because these organizations have huge experience in that field, plus they posses great connections and recruiting abilities which makes them capable of finding invistigators easily and effectively. They are also dedicated to monitor study results to ensure that the results are indeed reflecting the results of the study without any biased or unrealistic data.

A sponsor may transfer any or all of the sponsor's trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. Real benefit is that the sponsor does not have to spend their time investing in training the CRO resources for regulatory compliance, project knowledge, industry standards knowledge, or compound knowledge. The expertise and experience should already be there at the CRO project team. The sponsor company does not need to invest in time or cost training the CRO. CRO will setup their process and programs to follow the latest regulatory. requirements. The quality and consistency of the project are reliable. Great advantage to the pharmaceutical manufacturer, it gives the chance to hold the fixed costs at a minimum during the time of going over to the next project, if the project's results are not positive. The disadvantages are sponsor is generally hands-off in team selection, and as a result, the CRO will consider placing less costly, and thus, less experienced personnel on the project and still attempt to deliver it correctly. The valuable knowledge and experience gained about a compound in development is a benefit that goes directly to the CRO hands, and may be passed to future projects from other sponsors.

In my experience at Sloan Kettering we have encountered as many have mentioned advantages and disadvantages to using CROs. At Sloan we have an efficient and accomplished clinical department which includes management of clinical trials, contracts, etc and we have established relationships with CROs. However sometimes a sponsor wants to select the CRO and in that case we are basically forced to work with whichever CRO is selected, in these cases, it can sometimes take more time and delays are caused with putting contracts in place, protocols, etc because they are not familiar with Sloan standards and procedures and unfortunately having delays with clinical trials can be costly because especially in the field of oncology where patients need to get onto these clinical trials quickly in order to receive the appropriate treatment. Overall, I think most large institutions with a great clinical management team have existing relationships with CROs, but working with new CROs can prove challenging and can sometimes cause costly delays.

The biggest advantage to in hiring CRO is the expertise and experience that the company would provide. Do to their sole role in the industry. And the second biggest would be its cost efficiency of hiring an outside company to do the heavy lifting. Their developed system would Speedline the process turns of getting the maximum value from the money spent. The disadvantages could be actually hiring a trusted company that will be able to provide the necessary service. A second could be IP and confidentiality management, there would be a need for a strong legal team. And lastly, issue of communication management.

Clinical Research Organizations, or CROs, are very beneficial to companies to have certain responsibilities for creating products to be done. With CROs, companies save money as they do not have to worry about expenses for human resources or equipment. CROs will do accordingly to get the research done in a timely manner with their money. In addition, the CROs have more experience with projects that they are able to input their own knowledge to complete the research. Along with money, companies save time by using CROs. Companies do not to take time to figure out the requirements needed to complete the research. CROs will be responsible of making sure that the trials are completed according to schedule. One factor to consider with CROs is that companies share their product ideas by outsourcing, and as much as they are legally bound from releasing information on the product, there is the risk that it will be.