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Regulatory Medical Writing at Cognibrain


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Title: Regulatory Medical Writing at Cognibrain

Regulatory Medical Writing How to Manage
Multiple Projects?
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.

Here are the Medical Writing Tips to Manage
Multiple Projects Efficiently
  • 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.

  • 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.

  • 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.

  • 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
  • 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.

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.
Professional Medical Writing Services
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