Clinical Research Report Shell: An All-inclusive Manual

The clinical study report is an essential part of the regulatory submission process. Its writing and finalization are important milestones. Company sponsors try their best to achieve this milestone as early as the availability of clinical study data (tables, listings, and figures [TLFs]) to meet the planned timelines of the drug development process. However, due to the uncertainty about the length of clinical study data, it becomes difficult to assess the exact time required to write and finalize a clinical study report. Therefore, to meet the planned timelines, the current industry practice is to split a clinical study report writing into two parts, i.e., shell writing (before the availability of clinical study data) and results writing (after the availability of clinical study data). The purpose of this blog is to enlighten the readers on clinical study report shell writing.

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