Regulatory Medical Writing at Cognibrain

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Regulatory Medical Writing How to Manage
Multiple Projects?
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Regulatory Medical Writing

• Regulatory Medical Writing involves writing a
  study protocol and/or a clinical study report
  (CSR) of a project.
• However, sometimes the medical writer has to
  tackle multiple projects with converging
  deadlines and all the study teams demanding more
  and more of his time.

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Here are the Medical Writing Tips to Manage
Multiple Projects Efficiently
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• Identify the documents which are the most urgent
  and have the highest impact in a study.
  Prioritize them over those with the least impact.
• Assign a timeline to yourself with all the
  overlaying projects. This will help you identify
  the gaps in your workload and where you might
  need support.
• Explain the entire document completion process to
  the study team at the beginning of the project.
  Ask them for any changes to be made beforehand.
  Show them how large changes, ad hoc reviews etc.
  in the end can affect the timelines.

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• Write the methods section of the CSR once the
  client finalizes the protocol and statistical
  analysis plan.
• For writing CSRs, hold a results review meeting
  with the study team where you show them the way
  you plan to present the data. Discuss your
  opinions about the key messages and conclusions. 
  This will help you know what the study team wants
  exactly and how it must be presented.
• Take help from your colleagues to complete the
  projects with converging timelines. For example,
  as the lead medical writer, you can write the
  efficacy results more accurately, but you can
  assign a large in-text table or the safety
  section to your colleague.

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• Once you have completed the first draft of your
  document, call the study team for a live meeting
  and discuss. Any disagreements from the study
  team will be apparent at an early stage and you
  can resolve them quickly, thus moving the
  document swiftly to the next stage.
• Do not hurry and wait till you receive all the
  clients comments. Their comments may help
  resolve team contradictions. Moreover, while
  waiting you can work on another project from
  another client. Also, make sure you know the
  signatories of the study project.

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• Inform your QC and peer reviewers about any
  changes in the timeline changes. If you wish to
  deliver all your medical documents on time, you
  must ensure that all the reviewers know when they
  will be required to complete the work, how long
  will it take, and the degree of urgency of the
  project.
• Finally, be honest with your clients.
  Irrespective of how much projects you have, do
  not agree with a client if he has unrealistic
  expectations. Work with him to change the
  deadlines or medical document writing process as
  far as possible. A client knows better how to
  make changes so as to deliver the document on
  time rather than late.

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With these tips in hand, you need not worry about
the deadlines of your projects. Because now you
will be a master who can handle multiple projects
at one time.
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Professional Medical Writing Services
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To Know More

• Contact Us
• Email ID project_at_cognibrain.com
• Phone [phone]
• Visit us https//www.cognibrain.com/