A Novel Clinical Trial Procedure That's Changing How Patients Are Treated

The clinical trial protocol is an essential document for the successful conduct of a clinical trial. As per the US FDA, “Clinical Protocol should be submitted for each planned clinical study or trial. An original IND application submission lacking a clinical protocol is considered incomplete.”1 Therefore, a clinical trial protocol must be prepared to conduct any trial under the US FDA. Though it is mandatory, however, what is more important is what this clinical trial protocol contains. Other than the sponsor, only an experienced medical writer could assess the real value of a well-written clinical trial protocol that could generate quality data. This blog will discuss the importance of a clinical trial protocol in drug development, the challenges related to clinical trial protocol development, and the importance of hiring an experienced medical writer.

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