With any type of animal testing the main pitfall stems from delays. The process of ordering animals is time consuming and also limited. If you are completing an animal test on a specific animal then you would need to find multiple suppliers to purchase from because animal suppliers can run out of animals. If the animal testing is now being completed 1600 km away then it would be a wise decision to locate different suppliers in that area in advance. Build in time for delays within your testing schedule so that your study does not get overdue. Open the study to more than one type of animal testing so that you have an alternate option to complete the tests. Lastly, take into account the cost of the number of animal test that need to be conducted along with cost of transportation and maintenance while discussing the budget of the study due to the new testing location.

Animal testing procedures can encounter many pitfalls in the course of it's phase just as many other testing procedures such as clinical trials. Considering in this scenario that the company is using a university located 1000 mi away since a research member has connections can be helpful but also problematic if no contingency plan is established. To further elaborate on this contingency plan, I refer to time constraints, lack of communication and shortage on specific animals availability. To prevent any delays in the animal testing phase, a good approach would be to establish a list of possible animal suppliers in the area as a backup and gather a price list to compare. Suppliers can encounter shortages based on high demand and also can vary in price due to their scarcity. By creating a backup plan, this would help in preventing delays in the phase, another issue would be the cost of shipment, the larger to supply, the longer the distance, the more expensive the shipment can be overall. This can affect the overall project budget, as a company, it is best to ensure to pay attention to expenses, it is wise to gather quotes early on for comparison.

First of all, I think that the decision to outsource to this university just because a team member has connections there is a poor decision. In a best case scenario (which is probably what was assumed when making this decision), the team member will have more leverage with the lab to make sure they run the test exactly as planned and on time. However, this can also work in the other direction, since there is a conflict of interest. If something does go wrong, such as an unexpected result in the test, or a delay in the test, what may happen during the resolution of the problem is more of "how do I smooth this over to maintain a good relationship with this lab, since they are my former colleagues," instead of "what exactly went wrong, who is responsible, how can it be resolved and how will it impact the project?" So in the case of something going wrong in the test, which is probably a more likely situation than everything running exactly as planned, it can lead to compromises being made by the company since the team member feels bad for his colleagues, and in general it can lead to a messy situation where it is difficult to reach a resolution due to the conflict of interest. However, if this lab was selected not only because of connections, but because of having a good reputation and past history, and reasonable pricing and timing, a precaution that a company can take to avoid this situation is to not have the team member who has the connection to be leading this effort, and to keep his involvement in the interactions with this lab to a minimum.

I work at a non-profit. If a company outsources a study to a university there would need to be a formal contract in place (collaboration agreement, sponsored research, or service agreement) to cover the scope of the what university will be doing, budget, payment terms, IP terms, etc. This process is handled by our contracts/legal department and this could take several weeks (at best) just to get executed. Once the agreement is executed then the animals can be ordered and the project to take place. As @bb240 mentions there are pitfalls due to the distance that could also create delays. There are protocols used for animal studies and other SOPs required and this would be required to preform the research for the company. The budget needs to be defined, how many animals, how many days (when will they be sacrificed) etc.

Overall, it takes awhile to set up a collaboration/service agreement for a university to perform studies for a company. It might seem cheaper to use a university than a CRO, but in fact there are IDC rates in place which for my institution are about 73% IDC rate since we are in NYC- the overhead is high. So you would have the direct costs of how much the pre-clinical study would cost and then you would take 73% of that and add it to it! So it can become very expensive.

To avoid these pitfalls, the company should reach out to the Tech Transfer office at the university and start putting in place the formal agreement that will cover this project. The lab should make preparations for ordering the animals and making sure the proper protocols are up and ready for this particular project. There has to be communication with the company and the tech transfer office, the company and the lab, and the lab and the tech transfer office. Having a clearly defined study/budget and the appropriate approvals are necessary to even contemplate having a successful pre-clinical study done at a university.

assuming the university to which the study was outsourced to is competent to properly complete the task, as alexandrabuga stated, explicit instructions are vital for proper execution of the animal study. as bb254 stated, because of the distance of the university time delays are imminent, but can be mediated. to minimize delays, frequent phone or video meetings should take place to maintain continuous communication about the status of the study. the distance also introduces potential pitfalls in securing the data. minimizing data loss can be achieved by ensuring the data, when collected, is uploaded and stored on local servers and saved by both parties until the project is completed.

depending on the value/importance of the study, a staff member can be sent to the university to either oversee the study to visit periodically as another form of contact.

also as Alexandrabuga stated preparations for ordering the animals should, ensuring there is no issue with delivery quality and shipping times from an appropriate vendor.

Some great points made above, yes. You see some of the pitfalls that have happened with favoring close connections over sound business decisions, but as some of you correctly point out, the sound business decisions are not clear-cut either.

* University overhead can make an animal study nearly twice as expensive as doing it at a CRO
* Personal relationships can make problem solving a little more nuanced.
* University contracting and Tech Transfer departments are extremely slow. (Why wouldn't these same departments be as slow at a CRO?)

Why wouldn't these same departments be as as slow at a CRO? -Josh

According to Pharmamodels, "When evaluating the growth of CROs, the statistics show it all. Seven years ago, the biotech and pharmaceutical industry spent $60 billion of which $15 billion was outsourced. This means that CROs accounted for 25 percent of the market seven years ago, a number which has probably increased since then. The partnerships made between sponsors and CROs continue to grow, and there are now numerous networking websites that help connect CROs and Pharmaceutical companies connect".

This statement indicates that the CRO's provide efficiency for pre clinical research. This is a major benefit for pharma companies due to their strict deadlines and allocated budgets. CRO's help reduce the cost for biopharmaceuticals by relieving the overheads spending for the required trials. To answer the question, if CRO's are rapidly growing or even being outsourced which indicate that their process cannot be slow otherwise companies would not pursue them. Even Forbes magazine show that there is much greater interest in CRO's than even before due to low costs. A CRO would be providing the exact service and expertise required for the job and since it is an established company, there are professionals doing the work. Therefore, the attitude cannot be lax if the company's deadline has to be met.

Right, so the underlying message there is that CRO's are businesses that want to maximize their turnover. The more studies they do, the more money they make.

How is the situation different in a university? Obviously they also want to make money, but in this specific case of animal studies, that's not the main motivating factor. What is?

Looking at this situation presented here, there is a lot of pitfalls that you should put into consideration. First, you have to check the study design so that you don't discover any missing points and make sure everything is clear enough to start the project. Then you have to consider any delays caused by the distance to the lab or the time spent by the supplier to supply the animals. Just the fact that the university is 1000 mi away, that is a sign to prepare for any delay caused by commuting there and back. To make yourself more prepared, you can contact more than one animal supplier just in case one of them runs out of animals. The last thing is to be sure that there is enough money to cover the expenses.

The main motivating factor, in terms of animal studies, is conducting the study on these animals and seeing what the results are. The results will demonstrate if the research for the university is worth pursuing and these type of studies help identify for professors and doctors in the school if they should continue some of their research interest. Outside of that, I would speculate the motivation outside money for a university to conduct clinical research trails would be to bring prestige and a reputation to the school.

The pitfall to awarding the trial to this university could bring about ethical issues. With so many ties to the university one could assume possible manipulation of data to favor the clinical trial. Also, the risk of kickbacks associated with awarding the contract to alma mater.
Depending on the location of this lab the preclinical trials may not be conducted to specific guidelines. In certain countries animal rights may differ from that of the U.S. It is known that stressed rats develop chronic inflammatory conditions that can affect the overall data collected.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4594046/
The location of the site may also be an extra expense when traveling is involved. On the other hand the location might be very cheap but remember you always get what you pay for.

The University is interested in making connections with Industry-some investigators are in hopes to build a relationship in which the company will fund more research and be a source of funding for the lab. Others are doing it not only for the money, but in certain cases (as the contracts will determine) the ability to publish on the research. A PI always loves to add another publication to the books.

If you do a service agreement for a company, they may provide something to in the future. For example, maybe provide material (a drug) for internal research purposes under a Material Transfer Agreement or collaboration agreement. In this situation the lab would not have to pay for the material, they essentially get it for free but as everyone knows company's don't just give things for free. Industry material transfer agreements/ collaborations include strict restrictions and basically want the university to assign all of the rights away to any invention that arises in relation to the drug. This is why Tech Transfer Offices are crucial in reviewing/negotiating Industry contracts in order to protect the university's IP.

There are many pitfalls to consider with the animal study being doing so far away. The most important factor to consider is that the design of the study is thought out thoroughly and there are no missing aspects. In addition, there needs to be a guarantee that there is enough animal supply in that area for the study. Another factor to consider is that there will be importance given to the research. When doing research yourself, you give more importance to making sure that it gets done. However, when the research is being done at a different, distant location, the research may be given lower priority. Maybe one of the researchers on the team who designed the animal study should be present when the study is being completed. This way someone who has knowledge of the background as to why and how the study is being done will be able to oversee that the study is being done as needed. It would probably be better to have the animal study done at a closer location, to ensure that there will not be any delay in the research.

I think that the biggest problem that this type of situation can encounter may include communication. Because of the distance, regular in-house check ups may not be possible which may cause problems in the progress of the project. There will always be always be some sort of miscommunication when people do not talk and meet face to face. There will also be the issue of different understandings of the concept. This may need a different experimental design based on the different environment at which the lab is. Observing the procedures of the experiments may also cause trouble since there is distance.