-
krp76 replied to the topic Discussion Topic: Beyond experimental design issues in the forum Pre-clinical Device Development 7 years, 6 months ago
While working in industry I did come across a situation very similar to this, in which our company was conducting animal studies for a product under development. The constraint that we had was we had to conduct the trial at a specific test center that was pre-approved by the company and had a non-disclosure assigned. The test center was in Ohio and the main contingency that we took to ensure a properly conducted study is proper communication. First off we created a detailed protocol and went back and forth to ensure that the study and its’ parameters were properly understood by the lead investigator at the facility and there was no ambiguity in the procedure. Moreover, we also decided it was best to arrange the study so that we can send two employees during the initial testing phase of the animal trial to ensure the first round was conducted properly and work out any issues that the lab may have.
In the scenario presented above I would advise that the individual who chose the lab not be heavily involved further on so that it removes any bias from the study. Moreover, proper communication is key in ensuring that the study requirements are met, and if possible a site visit would be the best way in negating any issues.