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  • ih37 replied to the topic Discussion Topic: Beyond experimental design issues in the forum Pre-clinical Device Development 6 years, 7 months ago

    The main pitfalls with outsourcing to a long-distance university would be delays in the project, as mentioned in lecture, in that “animals take time to come in when ordered”. The long distance can also pose an issue to the product’s integrity during transporting (blood cell-based products can lose viability over long durations of travel despite following current cryopreservation protocols). Finally the long distance aspect can inhibit the study process since a project lead/representative is not likely to always be on site at the university. This is important for a project because the university must be administered the protocol, which cannot always be put into precise writing depending on the complexity of the product. Some research must occur within an ISO cleanroom, which most likely do not have a protocol for a live virtual tour. Therefore, if the study/research site is too far, it may lead to complications along the research process, which can delay further delay the project and/or result in unforeseen costs, which can overall result in the study getting cut down. A more feasible option is to hire a contract research organization (CRO), which simply has more experience in organizing research trials as well as partnering up with more pharma-research companies, and overall performs the work at a quicker pace. Also, as mentioned in lecture, if a university has too many projects and your project is not a priority to them, it may go neglected. On the other hand, if an industry-based research facility has too many projects, then they will at least attempt to complete them in a reasonable manner.