I believe that to determine if you should outsource a clinical trial or not, you should first develop a scope, WBS, Gantt chart, and budget for these tasks. This will give you an idea of how you would run the trial. Then contact a CRO and get a quote and outline of what they feel they can do. If they seem to have a better handle on the situation than you (suggesting good ideas that you didn't think of) and its more cost effective, then outsource. If you believe that you can do a better job then do the clinical trial within the company. The factors that you would consider are budget, WBS, and the Gantt chart.

Many times the clinical trials conducted by the CRO are done with the intention of gaining maximum profit out of the business without any concern for the safety and efficacy of the patients. In my opinion, the outsourcing policy only benefits the organization by extracting the poor, illiterate and needed population by giving them lucrative offers. In the past there have been some cases of unethical outsourcing done in India and Nigeria. In one of the case, the unethical clinical trials was conducted on the Bhopal gas tragedy victims, without informing them and without asking their consents.Thus, I feel it must be minimized in the developing nations. And the deign regulations must make sure that there is no compromise with the human safety. If the company decides to outsource ,the job opportunities should not be curtailed and the human volunteers should be treated with respect and they should be properly informed and their consent must be taken.

There are a lot of factors that can influence whether clinical trials should be outsourced or insourced. One could be the size of the company. Say a small company wanted to perform clinical trials, it wouldn’t be reasonable for them to do it on their own if they don’t have the capabilities. Rather it would be more cost-effective if it was outsourced and have other people who are more capable and effective to do the work. It is also important to ensure that the organization running the clinical trials are well certified. It is first important to figure out whether the depth of the clinical trials require the participation of external companies or if it’s okay to simply do it in-site. it is important to remember the capabilities of your clinical trial division and the cost that it can handle, otherwise, it would be a better idea to outsource such trials if they save more money and time.

From a website it stated, “Market Competition increased, with supply market seeing continuous mergers and acquisitions, resulting in consolidations and CROs”( clinical leader website). I think the reason for the outsourcing is because it may be to much work for one company to simply do. They may not have enough specialized employees to do the work. Employees may not want to work for the company. The bottom line is going to other companies helps to limit the amount of work an entire company may have to do. Therefore outsourcing may be a better approach because having to involve multiple processing groups may not be manageable for the PM who is in control of the overall project.

Outsourcing is best option for those who lacks the expertise or who lacks resources and this is the case with smaller companies. But now a days major pharma company is also outsourcing there clinical trial to CRO's because it's found that CRO's are able to finish this trials faster and now company can use its remaining resources to focus on other task like CAPA for findings, risk mitigation, regulatory or marketing.

Her is some finding which I tried to discuss over here.
According to the 2016 Nice Insight Contract Research - Preclinical and Clinical Survey,2 there was a big jump in expenditure for outsourcing services this year, maintaining the continuously escalating spend over the last five years. The majority of companies (38%) now spend $51 million to $100 million for outsourcing, and another 18% spend more than $100 million. That is a big increase from the previous year’s Nice Insight survey, where the vast majority (64%) spent $10 million to $50 million on outsourcing and only 23% spent more than $50 million.

Rising costs and falling productivity, among other trends, are driving industry companies to outsource an increasing range of functions to CROs to achieve cost savings. In addition to providing substantial global capacity to drug developers, CROs have become a critical contributor to clinical trial programs. According to a recent report by ResearchandMarkets, clinical trials conducted by CROs are completed up to 30% more quickly than those conducted in-house by pharma companies.3 That, of course, translates into a considerable cost savings and likely a faster market launch.

Deciding on when to outsource clinical trial or insource depending on the project, capabilities and resources needed. I think insourcing is more expensive for an organization as a result of implementing new processes to start a different division of the organization. Outsourcing uses the developed workforce of an outside organization to perform tasks. The benefit of outsourcing reduced costs, strengthened performance and flexibility. However when choosing a CRO, try to find the best solutions, NOT the cheapest, and allowing CROs to take on the risks.

When looking to decide if we should outsource work and let a CRO do it you must look at your technical and time availability. If your project team is running really behind on schedule because you chose to take your time, then it may be best to outsource your work so that you can finish your product on time and not lose any more sponsorships and potential money form investors. If the money you would make from sales and investing by finishing the project on time or ahead of time is more than you would spend on the CRO than outsource work to the CRO. Also, if your facility does not have the capability to perform the necessary testing that you would like to do than a CRO would be needed as well. Also, it is better to alleviate some of the risk that would come with performing the project on your own and to let a second party or third party vendor take on those risk. In addition, it could be helpful in comparing results if your facility or secondary source are producing different or poor results.

As stated above, CROs should be used when necessary. If a company has the time and money for it, then a reputable CRO would not be an issue if it was utilised. In addition, some small companies could possibly benefit from the use of a CRO, especially if they're new in the game and do not have the resources to run clinical trials themselves.
However, if a company is large enough and based well, moving clinical trials in house would be time and money saving in the long run.

I think outsourcing a clinical trial is the most efficient option for a medical device company. In my opinion I think that outsourcing will free up human resources for working on additional projects and ensure that the trial is completed by professionals as fast as possible while maintaining compliance with all the clinical trial rules and regulations. Having a clinical research organization conduct your clinical trial adds a level of certainty, knowing that clinical trials are that company's specialty.

I agree with gingeranderson, a company should look at how much time, effort, and cost its going to take to in-source a clinical trial. They then should call a CRO and get a quote from it and compare the two. I believe that in most cases, unless a company has some type of previous experience with clinical trials, it should hire a CRO. These companies are trained to handle clinical trials and take it from step A to Z. They're professionals and they might even be more accredited than trying to do things yourself. This will help the process go a lot faster and that energy spent in setting up your own trials, you could invest in another project. Another thing to look at is to compare CROs and see which one is the best with respect to cost rating.

One factor this can easily boil down to is the amount of resources that a company has. Should the company have the time, manpower, and money to invest in a trial, they should certainly undergo the trial themselves rather than sending it out to a CRO. There tends to be a higher amount of traceability and control when things are done in house rather than outside. That being said, I agree with what one person said about resource availability. If doing the clinical trial in house means losing resources that could be doing other things, then using a CRO may be wiser. Generally, smaller companies that don't have the equipment/trained personnel/money to do clinical trials themselves should rely on CRO's. Of course, it will not be this cut and dry. I believe even larger companies actually do a mix of sending some of their clincial trials to CRO's and doing some of them inhouse, just by nature of what their competencies are in. CRO's can have a wide range of capabilities that a company may not have (access to certain animals, clearances and approvals, personnel trained in a wide range of procedures, experience, etc) that can fill the gap that a company has.

I think it's better to outsource if you aren't as qualified to run a clinical trial. If you lack the resources in man power and knowledge you are better off hiring a CRO to do the clinical trial for you. This could prevent many pitfalls that can result in added costs to the clinical trial which is already very expensive. If the company has the man power and the monetary resources to run this clinical trial then it's okay to do it in house. It also depends on what is most favorable with the FDA. If they are looking for particularly certifications or procedures followed then the CRO might be more qualified to run the trial and increase chances of the FDA approving of the while process.

Not all companies have the capacity or the resource to run a clinical trial in house. Also, depending on the size and the scope of the project will determine if the clinical trial should be outsourced or in source. The amount of time and investment required to conduct, analyze, and document clinical trials has grown enormously and as such, many companies have chosen to focus on pure research, while contracting out development and regulatory work to contract research organizations (CROs). 
Both outsourcing and in-sourcing has its benefits and risks which needs to be considered before making a decision. As a small to medium-sized company, the decision regarding how to outsource your clinical trial activities requires a fully informed discussion of the pros and cons. A completely in-sourced model is not practical for a small to medium-sized company, given the challenges with a small clinical organization. 
In today’s environment of increased litigation, regulatory oversight, and focus on efficacy, some companies benefit from insourcing, with CRO employees working side by side with them to find the right process. For most companies, the need for appropriate staffing levels based on the phase of the study, having the required expertise based on the region of the clinical trial, and cost, are the main drivers for outsourcing clinical trial activities. 
As companies bring more and more activities in house, they face new challenges. With each new technology, a new skill set is required: additional hires, additional training, maybe even additional shop floor square footage. Once in place, each activity needs to justify its existence from a financial standpoint. Some of these drawbacks/limitations are what have lead companies to explore the option of increased outsourcing. With the digital age now truly upon us, the number of companies utilizing this popular strategy has even given rise to the birth of the virtual medical device company, a company that solely relies on outsourcing to create a product and meet market needs. 
In sum, choosing to contract an outsourcing company or choosing to take up such responsibilities in-house for clinical trials, will solely depend on the size and scope of the project and company, financial and resource capacity, time and management dedication.

I believe the most important factors would be if the company running the trial has adequate facilities and resources already present within the company. If a company does not already have these, it would take significant time and possibly delay the start of the trial in order to acquire facilities and resources. If the company does have the resources to run the trial themselves, it would be important to consider the timeline and budget of the project. It would most likely cost more to outsource the clinical trial to a CRO, however it is also likely that completing the trial themselves would take more time. It would be necessary to consider how the budget and schedule of the project would be effected by insourcing or outsourcing a clinical trial, and determine if either of these would be critical factors.