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Then, the last stage before going to clinical trial is preparing the regulatory documentation.
The templates below have been shared by other groups, and are free to use and adapt for your researchstudies.
Clinical Trials Strategy: The Clinical Development Plan
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Clinical Trials Strategy: The Clinical Development Plan
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This is a vital road map defining how the product will be developed through a series of clinical trials to achieve approval and market acceptance. The Clinical Development Plan is the blueprint of the entire clinical research strategy of a drug, which defines the critical path for the clinical program, including development, assessment, and decision points, and the project resource (personnel and budget) estimates. How much of this is different from the job you have done?
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