Design of a Medical Device Clinical Trial

 

Our company has an innovative fluid filled incubator for preterm infants which we need to take to clinical trials. We need individuals with experience in clinical trials who can do research and help put together the protocol for the clinical trial. Tasks involved include: 1) Critical review of literature a. Organizing scientific articles in preparation for study design b. Creating selection criteria such as list of key words for selected publications c. Reference list of relevant research papers 2) Selection of inclusion and exclusion criteria 3) Drafting the background section for the study 4) Drafting a document examining similar products and alternate therapies 5) Critical review of risks associated with use of device 6) Developing a Statistical Analysis Plan guidance to include: a. Study design and objectives b. Trial design c. Sample size justification d. Selection of study endpoints e. Detail of statistical methods used to analyze endpoints 7) Other tasks related to drafting clinical trial protocol, setup and execution of the trial.

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