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Showing posts with the label clinical research

The fundamentals of medical writing

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Fundamentals of medical writing Medical writers are people who write important documents about new medicines. These documents are sent to government organizations like the FDA (Food and Drug Administration) to get approval for the new drugs. These documents have to be very accurate, complete, and follow all the rules and laws. To write them correctly, medical writers need to know a lot about how new drugs are made. Medical writers also need to understand the science behind these medicines. They have to explain complex scientific ideas in a simple and clear way, especially for people who don't know much about science. So, they need to be good at both science and writing. 1. Definition: Medical writing is a branch of medical and pharmaceutical science, which deals with the process of communicating complex medical and scientific information in a clear, concise, and accurate manner to a variety of audiences, including healthcare professionals, patients, and the general community. D...

Importance of guidelines in medical writing

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  In the realm of medical writing, guidelines serve as the North Star, guiding authors through the intricate constellation of precision and clarity, importance of guidelines in medical writing Introduction:  Documents that offer direction or recommendations on how to create particular sorts of medical documents are known as guidelines in t he field of medical writing. Typically, they are created by professional associations like the American Medical Writers Association (AMWA) or the  International  Council  for  Harmonisation  of Technical Requirements for Pharmaceuticals for Human Use (ICH) . The objective behind providing guidelines is the standardization of data.  Guidelines in Regulatory Medical Writing Documents Purpose:    Guidelines may address a variety of subjects, such as: Medical document format and organization Language and terminology employed Reporting the results of clinical trials Creating informed consent documents...

Principles of Agile, Lean Six Sigma in the medical writing process.

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Principles of Agile, Lean Six Sigma in the medical writing process. Project management conventional process:  The 5 key steps of the project management method, which apply to all projects, are not an exception to medical writing. Project managers and medical writers should collaborate on projects. There may be some overlap or repetition, but the steps are usually completed in the following order. Project Initiation : The project's initial definition and approval occur during this phase. Along with the selection of the project manager, the project charter is created. Project Planning : The project manager develops a comprehensive plan for carrying out the project during this stage. The project's scope, timeline, budget, and risks must all be specified in this regard. Project Execution : During this phase, the project team puts the work that was planned during the prior phase into action. The project manager is in charge of keeping an eye on changes, troubleshooting, managing ris...