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What is development and clinical feasibility?
Development and clinical feasibility refers to the assessment of whether a proposed medical product or treatment can be successfully developed and tested in a clinical setting, evaluating factors such as scientific validity, market potential, and regulatory considerations.
Who is required to file development and clinical feasibility?
Typically, pharmaceutical companies, biotech firms, and medical device manufacturers that are seeking to develop new products and conduct clinical trials are required to file development and clinical feasibility.
How to fill out development and clinical feasibility?
To fill out development and clinical feasibility, applicants need to provide detailed information about the product's design, intended use, market analysis, study protocols, and regulatory compliance plans, usually following specific guidelines set by health authorities.
What is the purpose of development and clinical feasibility?
The purpose of development and clinical feasibility is to determine the practicality of carrying out a proposed clinical study, ensuring that all necessary conditions for a successful trial are met before proceeding.
What information must be reported on development and clinical feasibility?
Reported information generally includes project objectives, scientific rationale, target population, trial design, endpoints, potential risks, and statistical analysis plans.
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