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alexandrabuga replied to the topic Discussion Topic: Beyond experimental design issues in the forum Pre-clinical Device Development 7 years, 8 months ago
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.